<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04423211</url>
  </required_header>
  <id_info>
    <org_study_id>EA8191</org_study_id>
    <secondary_id>NCI-2020-02686</secondary_id>
    <secondary_id>EA8191</secondary_id>
    <secondary_id>EA8191</secondary_id>
    <secondary_id>U10CA180820</secondary_id>
    <nct_id>NCT04423211</nct_id>
  </id_info>
  <brief_title>Treating Prostate Cancer That Has Come Back After Surgery With Apalutamide and Targeted Radiation Based on PET Imaging</brief_title>
  <official_title>Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients With Post-ProstaTEctomy Biochemical Recurrence (INDICATE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ECOG-ACRIN Cancer Research Group</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Eastern Cooperative Oncology Group</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase III trial tests two questions by two separate comparisons of therapies. The first&#xD;
      question is whether enhanced therapy (apalutamide in combination with abiraterone +&#xD;
      prednisone) added to standard of care (prostate radiation therapy and short term androgen&#xD;
      deprivation) is more effective compared to standard of care alone in patients with prostate&#xD;
      cancer who experience biochemical recurrence (a rise in the blood level of prostate specific&#xD;
      antigen [PSA] after surgical removal of the prostate cancer).&#xD;
&#xD;
      A second question tests treatment in patients with biochemical recurrence who show prostate&#xD;
      cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET)&#xD;
      imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced&#xD;
      therapy (apalutamide in combination with abiraterone + prednisone) is tested.&#xD;
&#xD;
      Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the&#xD;
      pelvis. Androgens are hormones that may cause the growth of prostate cancer cells.&#xD;
      Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor&#xD;
      cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor&#xD;
      cells and shrink tumors that have spread. This trial may help doctors determine if using PET&#xD;
      results to deliver more tailored treatment (i.e., adding apalutamide, with or without&#xD;
      targeted radiation therapy, to standard of care treatment) works better than standard of care&#xD;
      treatment alone in patients with biochemical recurrence of prostate cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. For patients without PET-evidence of extrapelvic metastases, to evaluate whether the&#xD;
      addition of enhanced systemic therapy to standard of care (SOC) salvage radiation therapy&#xD;
      (RT) could prolong progression-free survival (PFS).&#xD;
&#xD;
      II. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the&#xD;
      addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could&#xD;
      prolong PFS.&#xD;
&#xD;
      III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy&#xD;
      - Prostate (FACT-P) total score, at 6 months between the two sets of treatment arms (A with B&#xD;
      and C with D). (QUALITY OF LIFE [QOL] OBJECTIVE)&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate overall survival in each arm. II. To evaluate event-free survival in each arm.&#xD;
      III. To evaluate time to prostate-specific antigen (PSA) progression in each arm.&#xD;
&#xD;
      IV. To assess the incidence of adverse events with the addition of enhanced systemic therapy&#xD;
      in patients without PET-evidence of extrapelvic metastases.&#xD;
&#xD;
      V. To assess the incidence of adverse events with local ablative metastasis-directed RT for&#xD;
      PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases.&#xD;
&#xD;
      VI. To estimate the detection rate of PET at the patient and regional level, and to evaluate&#xD;
      its concordance with the follow-up Food and Drug Administration (FDA)-approved conventional&#xD;
      imaging modalities (CIM) (as available) considered standard-of-care per institution,&#xD;
      including computed tomography (CT), bone scintigraphy, magnetic resonance imaging (MRI) and&#xD;
      PET imaging.&#xD;
&#xD;
      VII. To determine the distribution of PET-positive lesions among anatomic sites (prostate&#xD;
      fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone&#xD;
      metastases) in patients with post-radical prostatectomy (RP) biochemical recurrence (BCR),&#xD;
      correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters.&#xD;
&#xD;
      VIII. To compare the change in overall QOL, measured by FACT-P total score, from baseline to&#xD;
      6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) IX.&#xD;
      To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy&#xD;
      [FACIT]-Fatigue scores) at 6 months between the two sets of treatment arms (A with B and C&#xD;
      with D). (QOL OBJECTIVE) X. To compare patient-reported overall QOL (FACT-P scores), fatigue&#xD;
      (FACIT-Fatigue scores) and pain interference (patient reported outcomes measurement&#xD;
      information system [PROMIS] Pain Interference Short Form 4a) between the two sets of&#xD;
      treatment arms (A with B and C with D) at the time of disease progression. (QOL OBJECTIVE)&#xD;
&#xD;
      EXPLORATORY OBJECTIVES:&#xD;
&#xD;
      I.To determine the value of repeat PET (PET2) at time of second PSA progression, clinical&#xD;
      concern for progression, or 12 months after completion of enhanced systemic therapy,&#xD;
      whichever comes first to assess response to therapy (enhanced systemic therapy +/- focal RT&#xD;
      and/or androgen deprivation therapy [ADT]) compared to available standard response&#xD;
      assessments (PSA and conventional imaging modalities [CIM]).&#xD;
&#xD;
      II. To compare cognitive function, measured by FACT - cognitive function (Cog) peritoneal&#xD;
      cancer index (PCI) and total scores, between the three treatment arms receiving enhanced&#xD;
      systemic treatment with ADT and apalutamide (Arms B, C, and D) and antiandrogen therapy (ADT)&#xD;
      alone (Arm A) at 6 and 12 month. (QOL OBJECTIVE) III. To compare the change in cognitive&#xD;
      function, measured by change in FACT-Cog PCI and total scores, from baseline to 6 and&#xD;
      baseline to 12 months, between the three treatment arms receiving enhanced systemic treatment&#xD;
      with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. (QOL&#xD;
      OBJECTIVE) IV. To characterize longitudinal change in cognitive function between baseline and&#xD;
      24 months in patients with prostate cancer receiving treatment for biochemical recurrence&#xD;
      (BCR) and define clinical and disease related characteristics associated with greater&#xD;
      cognitive change by the FACT-Cog PCI and total scores. (QOL OBJECTIVE)&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C&#xD;
      or D and receiving fluciclovine F18 intravenously (IV) undergo a repeat PET2 at time of PSA&#xD;
      progression or clinical concerns for progression or 12 months after completion of enhanced&#xD;
      systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for&#xD;
      PET1 do not undergo PET2.&#xD;
&#xD;
      STEP 1: Patients are randomized to 1 of 4 arms based on results of fluciclovine F18 PET/CT or&#xD;
      PET/MR in Step 0.&#xD;
&#xD;
      ARM A (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC external beam&#xD;
      radiation therapy (EBRT) for 6 months. Patients also receive goserelin acetate subcutaneously&#xD;
      (SC), leuprolide acetate intramuscularly (IM), triptorelin IM, relugolix orally (PO), or&#xD;
      degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days&#xD;
      after start of EBRT. All treatment continues for 6 months in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      ARM B (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive&#xD;
      goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as&#xD;
      in Arm A. Patients also receive apalutamide PO once daily (QD) for 6 months in the absence of&#xD;
      disease progression or unacceptable toxicity.&#xD;
&#xD;
      ARM C: (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive&#xD;
      goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as&#xD;
      in Arm A. Patients also receive apalutamide PO QD as in Arm B.&#xD;
&#xD;
      ARM D (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive&#xD;
      goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as&#xD;
      in Arm A and apalutamide PO QD as in Arm B. Patients also undergo stereotactic body radiation&#xD;
      therapy (SBRT) or 3-dimensional (3D) conformal radiation therapy (CRT), intensity-modulated&#xD;
      radiation therapy (IMRT) (including volume modulated arc therapy [VMAT]), and&#xD;
      intensity-modulated proton therapy (IMPT) over 3-10 fractions in the absence of disease&#xD;
      progression or unacceptable toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up every 3 months for the first 2&#xD;
      years, every 6 months for years 3-5, and then annually for years 6-10.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2032</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2032</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival (PFS)</measure>
    <time_frame>From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years</time_frame>
    <description>The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS prolongation in patients without PET-evidence of extrapelvic metastases</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFS prolongation in patients with PET-evidence of extrapelvic metastases</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Up to 24 months</time_frame>
    <description>Descriptive statistics will be used to characterize QOL over time in each arm.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>From randomization to death or date last known alive, assessed up to 10 years</time_frame>
    <description>Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare OS between the two arms in each cohort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival</measure>
    <time_frame>From randomization to radiographic progression by conventional imaging or PET, symptomatic disease, or initiation of new treatment for the disease or death, whichever occurs first, assessed up to 10 years</time_frame>
    <description>Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare EFS between the two arms in each cohort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to prostate-specific antigen (PSA) progression</measure>
    <time_frame>From randomization to documented PSA progression or radiographic progression, whichever occurs first, assessed up to 10 years</time_frame>
    <description>Patients without any progression will be censored at the date of last disease assessment that shows free of PSA progression. Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare time to PSA progression between the two arms in each cohort.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>Toxicity will be defined using the Common Terminology Criteria for Adverse Events.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Detection rate of fluciclovine F18 (18F-fluciclovine) PET</measure>
    <time_frame>At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years</time_frame>
    <description>For the detection rate, the proportion of baseline standard of care 18F-fluciclovine PET (PET1) positive results at the patient and regional (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) level will be calculated and its 95% confidence interval will be estimated using the Exact method based on the binomial distribution.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Concordance of detection rate with the follow-up conventional imaging modalities (CIM)</measure>
    <time_frame>At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years</time_frame>
    <description>Will use Cohen's Kappa coefficient to measure the agreement between dichotomized PET results and the dichotomized CIM results. Baseline CIM comparison will not be performed because as per our study eligibility criteria, baseline CIM will be negative for metastases.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of 18F-fluciclovine PET-positive lesions among anatomic sites</measure>
    <time_frame>Baseline</time_frame>
    <description>The rate of 18F-fluciclovine PET-positive lesions will be reported for each anatomic site, including prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases. Their confidence intervals will be estimated using the Exact method for the binomial distribution. To evaluate if PSA (level, doubling time, velocity) and other relevant clinical parameters affects the positivity distribution, will use the logistic regression to model with the binary outcome (positive vs. negative from PET) and covariates will include anatomic site, PSA, and other clinical parameters. Will test the interactions between anatomic site and PSA (plus other clinical parameters) to see if the positivity distribution across anatomic site may change according to the levels of the interacted terms. Will use the technique of generalized estimating equation to account for the outcome correlations within subjects.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Value of repeat PET to assess response to therapy compared to standard response assessments</measure>
    <time_frame>At time of second PSA recurrence or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years</time_frame>
    <description>Analyses will be conducted to evaluate qualitative visual evidence of 18F-fluciclovine PET positive metastatic lesions and quantitative PET standardized-uptake value (SUV) changes on a lesion-to-lesion basis from 18F-fluciclovine PET1 (baseline) to PET2 on visually determined sites of recurrence and metastatic disease. This will be compared to reference standard-of-care conventional imaging (Prostate Cancer Working Group 2 criteria) and PSA response at PET2 time point to determine PET2 response to therapy. PET2 visual and quantitative assessment will also be compared to PFS in the time-to-event analysis using a log-rank test (PET2 visual assessment) and a Cox proportional hazards regression (PET2 quantitative assessment). PET SUV parameters to be obtained at PET1 and PET2 will include SUVmax, SUVpeak. PET SUV change from PET1 to PET2 will include absolute SUVmax and SUVpeak change (PET2-PET1) and percent change of SUVmax and SUVpeak (% change = 100*[(PET2-PET1)/PET1]).)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison - Functional Assessment of Cancer Therapy (FACT)- prostate (P)</measure>
    <time_frame>At baseline and 3, 6, 9, 12 months</time_frame>
    <description>For the PET-negative cohort, with 216 analyzable patients in each arm, the study will have about 84% power to detect a 6-point (0.29 standard deviation) difference between the two arms using a two-sample t test with two-sided type I error of 0.05. The power will be greater than 99% if the difference between the two arms is 10 points (0.48 standard deviation). For the PET-positive cohort, with 146 analyzable patients in each arm, the study will have 68% and 98% power to detect a 6-point (0.29 standard deviation) and a 10-point (0.48 standard deviation) differences between the two arms, respectively, using the same test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue</measure>
    <time_frame>Baseline up to 6 months</time_frame>
    <description>A paired t test will be used to compare FACT-P scores at these two time points in each arm. A two-sample t test will be performed to compare the changes in FACT-P scores from baseline to 6 months between the two arms of each cohort. The FACIT-Fatigue scores at 6 months will be compared between the two arms of each cohort using a two-sample t test.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QOL Assessments at Progression</measure>
    <time_frame>Up to 10 years</time_frame>
    <description>A paired t test will be used to compare FACT-P total scores, FACIT-Fatigue scores and pain scores at these two time points in each arm. The changes in these scores from baseline to progression will be evaluated in each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FACT- cognitive functioning (Cog)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will be compared between two groups of patients on this study, patients receiving antiandrogen therapy (ADT) + apalutamide (Arms B, C and D) and patients receiving ADT alone (Arm A), at different time points. To ensure similarity of the three arms with systemic treatments (Arms B, C and D), a comparison in FACT-Cog total scores among these three arms will be performed using the Kruskal-Wallis test before combining them together to be compared with Arm A.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">804</enrollment>
  <condition>Biochemically Recurrent Prostate Carcinoma</condition>
  <condition>Metastatic Prostate Carcinoma</condition>
  <condition>Prostate Adenocarcinoma</condition>
  <condition>Stage IVB Prostate Cancer AJCC v8</condition>
  <arm_group>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.&#xD;
STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.&#xD;
STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.&#xD;
STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.&#xD;
STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>3-Dimensional Conformal Radiation Therapy</intervention_name>
    <description>Undergo 3D CRT</description>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>3-dimensional radiation therapy</other_name>
    <other_name>3D Conformal</other_name>
    <other_name>3D CONFORMAL RADIATION THERAPY</other_name>
    <other_name>3D CRT</other_name>
    <other_name>3D radiotherapy</other_name>
    <other_name>3D-CRT</other_name>
    <other_name>Conformal Therapy</other_name>
    <other_name>Radiation Conformal Therapy</other_name>
    <other_name>Radiation, 3D Conformal</other_name>
    <other_name>Three dimensional external beam radiation therapy (procedure)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Apalutamide</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>ARN 509</other_name>
    <other_name>ARN-509</other_name>
    <other_name>ARN509</other_name>
    <other_name>Erleada</other_name>
    <other_name>JNJ 56021927</other_name>
    <other_name>JNJ-56021927</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Computed Tomography</intervention_name>
    <description>Undergo PET/CT</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>CAT</other_name>
    <other_name>CAT Scan</other_name>
    <other_name>Computed Axial Tomography</other_name>
    <other_name>Computerized Axial Tomography</other_name>
    <other_name>Computerized axial tomography (procedure)</other_name>
    <other_name>Computerized Tomography</other_name>
    <other_name>CT</other_name>
    <other_name>CT Scan</other_name>
    <other_name>tomography</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Degarelix</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>FE200486</other_name>
    <other_name>Firmagon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>External Beam Radiation Therapy</intervention_name>
    <description>Undergo EBRT</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>Definitive Radiation Therapy</other_name>
    <other_name>EBRT</other_name>
    <other_name>External Beam Radiation</other_name>
    <other_name>External Beam Radiotherapy</other_name>
    <other_name>External Beam Radiotherapy (conventional)</other_name>
    <other_name>External Beam RT</other_name>
    <other_name>external radiation</other_name>
    <other_name>External Radiation Therapy</other_name>
    <other_name>external-beam radiation</other_name>
    <other_name>Radiation, External Beam</other_name>
    <other_name>Teleradiotherapy</other_name>
    <other_name>Teletherapy</other_name>
    <other_name>Teletherapy Radiation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fluciclovine F18</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>(18F)Fluciclovine</other_name>
    <other_name>(18F)GE-148</other_name>
    <other_name>18F-Fluciclovine</other_name>
    <other_name>[18F]FACBC</other_name>
    <other_name>Anti-(18f)FABC</other_name>
    <other_name>Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid</other_name>
    <other_name>Anti-[18F] FACBC</other_name>
    <other_name>Axumin</other_name>
    <other_name>Fluciclovine (18F)</other_name>
    <other_name>FLUCICLOVINE F-18</other_name>
    <other_name>GE-148 (18F)</other_name>
    <other_name>GE-148 F-18</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Goserelin Acetate</intervention_name>
    <description>Given SC</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>ZDX</other_name>
    <other_name>Zoladex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Intensity-Modulated Proton Therapy</intervention_name>
    <description>Undergo IMPT</description>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>IMPT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Intensity-Modulated Radiation Therapy</intervention_name>
    <description>Undergo IMRT</description>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>IMRT</other_name>
    <other_name>Intensity modulated radiation therapy (procedure)</other_name>
    <other_name>Intensity Modulated RT</other_name>
    <other_name>Intensity-Modulated Radiotherapy</other_name>
    <other_name>Radiation, Intensity-Modulated Radiotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Leuprolide Acetate</intervention_name>
    <description>Given IM</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>A-43818</other_name>
    <other_name>Abbott 43818</other_name>
    <other_name>Abbott-43818</other_name>
    <other_name>Carcinil</other_name>
    <other_name>Depo-Eligard</other_name>
    <other_name>Eligard</other_name>
    <other_name>Enanton</other_name>
    <other_name>Enantone</other_name>
    <other_name>Enantone-Gyn</other_name>
    <other_name>Ginecrin</other_name>
    <other_name>LEUP</other_name>
    <other_name>Leuplin</other_name>
    <other_name>Leuprorelin Acetate</other_name>
    <other_name>Lucrin</other_name>
    <other_name>Lucrin Depot</other_name>
    <other_name>Lupron</other_name>
    <other_name>Lupron Depot</other_name>
    <other_name>Lupron Depot-3 Month</other_name>
    <other_name>Lupron Depot-4 Month</other_name>
    <other_name>Lupron Depot-Ped</other_name>
    <other_name>Lutrate</other_name>
    <other_name>Procren</other_name>
    <other_name>Procrin</other_name>
    <other_name>Prostap</other_name>
    <other_name>TAP-144</other_name>
    <other_name>Trenantone</other_name>
    <other_name>Uno-Enantone</other_name>
    <other_name>Viadur</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Magnetic Resonance Imaging</intervention_name>
    <description>Undergo PET/MR</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>Magnetic Resonance</other_name>
    <other_name>Magnetic resonance imaging (procedure)</other_name>
    <other_name>Magnetic Resonance Imaging Scan</other_name>
    <other_name>Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance</other_name>
    <other_name>MR</other_name>
    <other_name>MR Imaging</other_name>
    <other_name>MRI</other_name>
    <other_name>MRI Scan</other_name>
    <other_name>NMR Imaging</other_name>
    <other_name>NMRI</other_name>
    <other_name>Nuclear Magnetic Resonance Imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Positron Emission Tomography</intervention_name>
    <description>Undergo PET/CT or PET/MR</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>Medical Imaging, Positron Emission Tomography</other_name>
    <other_name>PET</other_name>
    <other_name>PET Scan</other_name>
    <other_name>Positron emission tomography (procedure)</other_name>
    <other_name>Positron Emission Tomography Scan</other_name>
    <other_name>Positron-Emission Tomography</other_name>
    <other_name>proton magnetic resonance spectroscopic imaging</other_name>
    <other_name>PT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Relugolix</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea</other_name>
    <other_name>Orgovyx</other_name>
    <other_name>TAK 385</other_name>
    <other_name>TAK-385</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Stereotactic Body Radiation Therapy</intervention_name>
    <description>Undergo SBRT</description>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>SABR</other_name>
    <other_name>SBRT</other_name>
    <other_name>Stereotactic Ablative Body Radiation Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triptorelin</intervention_name>
    <description>Given IM</description>
    <arm_group_label>Arm A (EBRT, short-term androgen deprivation therapy [STAD])</arm_group_label>
    <arm_group_label>Arm B (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm C (EBRT, STAD, apalutamide)</arm_group_label>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>6-D-Tryptophan-LH-RH</other_name>
    <other_name>6-D-Tryptophanluteinizing Hormone-releasing Factor</other_name>
    <other_name>AY-25650</other_name>
    <other_name>CL-118,532</other_name>
    <other_name>Detryptoreline</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Volume Modulated Arc Therapy</intervention_name>
    <description>Undergo VMAT</description>
    <arm_group_label>Arm D (EBRT, STAD, apalutamide, RT)</arm_group_label>
    <other_name>VMAT</other_name>
    <other_name>Volumetric Modulated Arc Therapy (procedure)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STEP 0: REGISTRATION ELIGIBILITY CRITERIA&#xD;
&#xD;
          -  Patient must be male and &gt;= 18 years of age.&#xD;
&#xD;
          -  Patient must have had a radical prostatectomy (RP) as definitive therapy for&#xD;
             histopathologically-proven prostatic adenocarcinoma&#xD;
&#xD;
          -  Patient must have biochemical recurrence (BCR) after RP, defined as follows:&#xD;
&#xD;
               -  If time to BCR, defined as time to first detectable PSA ( &gt; lower limit of normal&#xD;
                  for assay used) after RP, is &lt; 12 months, a minimum PSA level of &gt;= 0.2 ng/mL and&#xD;
                  a confirmatory reading of &gt;= 0.2 ng/mL is required, per the American Urological&#xD;
                  Association (AUA) definition (Note: patients with a persistent PSA reading of at&#xD;
                  least 0.2 ng/mL are eligible)&#xD;
&#xD;
               -  If time to BCR, defined as time to first detectable PSA (&gt; lower limit of normal&#xD;
                  for assay used) after RP, is &gt;= 12 months, a minimum absolute PSA of 0.5 ng/mL is&#xD;
                  required&#xD;
&#xD;
               -  If the patient has a detectable PSA (&gt; lower limit of normal for assay used) at&#xD;
                  any time after RP AND has an eligible baseline SOC PET (PET1) with at least one&#xD;
                  positive lesion in any location, then there is no minimum PSA requirement&#xD;
&#xD;
          -  Patients must have no definite evidence for extrapelvic metastatic disease by&#xD;
             conventional imaging modalities (CIM) (CT abdomen/pelvis or MRI abdomen/pelvis AND&#xD;
             bone scintigraphy, or equivalent), within 26 weeks prior to Step 0 registration. If a&#xD;
             patient only has a study-eligible PET/CT or PET/MR (i.e., PET done without prior CIM):&#xD;
             if the PET is negative for extrapelvic lesions, then baseline CIM is NOT required. If&#xD;
             the PET positive for extrapelvic lesions, then patient should have a baseline CT/MRI&#xD;
             for soft tissue lesions and/or a bone scan for osseous lesions&#xD;
&#xD;
               -  Study eligible = PET using FDA-approved radiotracer and performed within 16 weeks&#xD;
                  prior to study registration&#xD;
&#xD;
          -  Extra-pelvic metastases is defined as any osseous metastases and/or any extrapelvic&#xD;
             soft tissue, lymph nodes and organ metastases; extra-pelvic is defined as superior to&#xD;
             common iliac bifurcation, outside of standard prostate bed + whole pelvis nodal RT&#xD;
             fields. Baseline PET/CT or PET/MR scan (PET1) is eligible for this study if the SOC&#xD;
             PET scan is completed with an FDA approved radiotracer for prostate cancer after Step&#xD;
             0 registration and prior to Step 1 randomization OR up to 16 weeks prior to Step 0&#xD;
             registration&#xD;
&#xD;
          -  Patient must be a candidate for SOC post-prostatectomy radiation therapy (RT) to the&#xD;
             prostate bed and pelvic nodes with androgen deprivation therapy (ADT)&#xD;
&#xD;
          -  Patient must have the ability to understand and the willingness to sign a written&#xD;
             informed consent document. Patients with impaired decision-making capacity (IDMC) who&#xD;
             have a legally authorized representative (LAR) or caregiver and/or family member&#xD;
             available will also be considered eligible&#xD;
&#xD;
          -  Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2&#xD;
&#xD;
          -  Patient must not have started ADT for biochemical recurrence prior to baseline PET&#xD;
             (PET1) imaging. A short course of low-dose anti-androgen such as bicalutamide, given&#xD;
             after baseline study PET/CT but prior to study registration, is permitted as a brief&#xD;
             temporizing measure in advance of starting protocol-approved SOC ADT.&#xD;
&#xD;
          -  Patient must not be enrolled in another therapeutic clinical trial&#xD;
&#xD;
          -  Patient must be able to lie flat and still for approximately 20-30 minutes or&#xD;
             otherwise tolerate a PET scan and radiation treatment planning and delivery&#xD;
&#xD;
          -  Patients undergoing a PET/MR must meet local institutional safety guidelines for MRI&#xD;
&#xD;
          -  Patient must not have history of seizures or known condition that may cause&#xD;
             predisposal to seizures (e.g., stroke or head trauma resulting in loss of&#xD;
             consciousness) within 1 year prior to registration&#xD;
&#xD;
          -  Patient must not have history of inflammatory bowel disease or any gastrointestinal&#xD;
             disorder affecting absorption that is expected to increase risk of complication from&#xD;
             radiotherapy&#xD;
&#xD;
          -  Hemoglobin (Hgb) &gt;= 9.0 g/dL (independent of transfusion and/or growth factors within&#xD;
             3 months prior to Step 0 registration) (obtained within 8 weeks prior to Step 0&#xD;
             registration)&#xD;
&#xD;
          -  Leukocytes &gt;= 3,000/mcL (obtained within 8 weeks prior to Step 0 registration)&#xD;
&#xD;
          -  Absolute neutrophil count &gt;= 1,500/mcL (obtained within 8 weeks prior to Step 0&#xD;
             registration)&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcL (obtained within 8 weeks prior to Step 0 registration)&#xD;
&#xD;
          -  Total bilirubin &lt; 1.5 x institutional upper limit of normal (ULN) (patients with&#xD;
             Gilbert's syndrome, if total bilirubin is &gt; 1.5 x ULN, must have a direct bilirubin of&#xD;
             &lt; 1.5 x ULN to be eligible) (obtained within 8 weeks prior to Step 0 registration)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase&#xD;
             [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])&#xD;
             =&lt; 2.5 x institutional ULN (obtained within 8 weeks prior to Step 0 registration)&#xD;
&#xD;
          -  Creatine &lt; 1.5 x instituional ULN (or measured creatinine clearance &gt; 30 mL/min)&#xD;
&#xD;
          -  Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral&#xD;
             therapy with undetectable viral load within 6 months are eligible for this trial&#xD;
&#xD;
          -  Patients with known history or current symptoms of cardiac disease, or history of&#xD;
             treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac&#xD;
             function using the New York Heart Association Functional Classification. To be&#xD;
             eligible for this trial, patients should be class I or II (by patient symptoms) or A&#xD;
             or B (by objective assessment)&#xD;
&#xD;
          -  Patient must not have completed a course of prior pelvic radiation therapy for any&#xD;
             reason&#xD;
&#xD;
          -  Patient must agree not to father children while on study&#xD;
&#xD;
          -  Patient must be English or Spanish speaking to be eligible for the QOL component of&#xD;
             the study&#xD;
&#xD;
               -  NOTE: Sites cannot translate the associated QOL forms&#xD;
&#xD;
          -  STEP 1: RANDOMIZATION ELIGIBILITY CRITERIA&#xD;
&#xD;
          -  Patient must have completed a baseline SOC PET/CT or PET/MR (PET1 scan) using FDA&#xD;
             approved radiotracer with results of extra-pelvic metastases involvement known&#xD;
             (positive or negative). The PET1 must have been completed after Step 0 registration&#xD;
             and prior to Step 1 randomization OR up to 12 weeks prior to Step 0 registration&#xD;
&#xD;
          -  For patients with negative extra-pelvic metastases, PET-imaging status of intra-pelvic&#xD;
             nodes must be known (positive or negative)&#xD;
&#xD;
          -  For patients with positive extra-pelvic metastases (defined as any PET positive&#xD;
             lesions outside of standard salvage RT fields [prostate bed +/- typical whole&#xD;
             pelvis]), the number of extra-pelvic lesions must be known (1 - 5 or &gt; 5 extra-pelvic&#xD;
             lesions)&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neha Vapiwala</last_name>
    <role>Principal Investigator</role>
    <affiliation>ECOG-ACRIN Cancer Research Group</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Anchorage Associates in Radiation Medicine</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>98508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alaska Breast Care and Surgery LLC</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alaska Oncology and Hematology LLC</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alaska Women's Cancer Care</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Anchorage Oncology Centre</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Katmai Oncology Group</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Alaska Medical Center</name>
      <address>
        <city>Anchorage</city>
        <state>Alaska</state>
        <zip>99508</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>907-212-6871</phone>
      <email>AKPAMC.OncologyResearchSupport@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Center at Saint Joseph's</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>602-406-0777</phone>
      <email>CancerInstitute@DignityHealth.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Fort Smith</name>
      <address>
        <city>Fort Smith</city>
        <state>Arkansas</state>
        <zip>72903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-378-9373</phone>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mission Hope Medical Oncology - Arroyo Grande</name>
      <address>
        <city>Arroyo Grande</city>
        <state>California</state>
        <zip>93420</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>805-219-4673</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Saint Joseph Medical Center/Disney Family Cancer Center</name>
      <address>
        <city>Burbank</city>
        <state>California</state>
        <zip>91505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>818-847-4793</phone>
      <email>Najee.Boucher@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center �� Carmichael</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy San Juan Medical Center</name>
      <address>
        <city>Carmichael</city>
        <state>California</state>
        <zip>95608</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-556-3301</phone>
      <email>OncologyResearch@DignityHealth.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Scott M. Glaser</last_name>
      <phone>626-218-2247</phone>
      <email>sglaser@coh.org</email>
    </contact>
    <investigator>
      <last_name>Scott M. Glaser</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center - Elk Grove</name>
      <address>
        <city>Elk Grove</city>
        <state>California</state>
        <zip>95758</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-556-3301</phone>
      <email>OncologyResearch@DignityHealth.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UC San Diego Moores Cancer Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>858-822-5354</phone>
      <email>cancercto@ucsd.edu</email>
    </contact>
    <investigator>
      <last_name>James M. Randall</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Los Angeles County-USC Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>USC / Norris Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UCLA / Jonsson Comprehensive Cancer Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-798-0719</phone>
    </contact>
    <investigator>
      <last_name>Amar Kishan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center - Rocklin</name>
      <address>
        <city>Rocklin</city>
        <state>California</state>
        <zip>95765</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-556-3301</phone>
      <email>OncologyResearch@DignityHealth.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center - Sacramento</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95816</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-556-3301</phone>
      <email>OncologyResearch@DignityHealth.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Pacific Central Coast Health Center-San Luis Obispo</name>
      <address>
        <city>San Luis Obispo</city>
        <state>California</state>
        <zip>93401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>805-219-4673</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mission Hope Medical Oncology - Santa Maria</name>
      <address>
        <city>Santa Maria</city>
        <state>California</state>
        <zip>93444</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>805-219-4673</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Woodland Memorial Hospital</name>
      <address>
        <city>Woodland</city>
        <state>California</state>
        <zip>95695</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>916-556-3301</phone>
      <email>OncologyResearch@DignityHealth.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penrose-Saint Francis Healthcare</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Penrose</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Francis Cancer Center</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80923</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Porter Adventist Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Anthony Hospital</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Littleton Adventist Hospital</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Longmont United Hospital</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Parker Adventist Hospital</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80138</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Mary Corwin Medical Center</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81004</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>719-776-6550</phone>
      <email>ResearchTracking@Centura.Org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sibley Memorial Hospital</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20016</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>202-243-2373</phone>
      <email>jquiver1@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Curtiland Deville</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83712</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Caldwell</name>
      <address>
        <city>Caldwell</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kootenai Health - Coeur d'Alene</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Fruitland</name>
      <address>
        <city>Fruitland</city>
        <state>Idaho</state>
        <zip>83619</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Idaho Urologic Institute-Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>734-712-3671</phone>
      <email>stephanie.couch@stjoeshealth.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Nampa</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83686</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Nampa</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83687</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kootenai Clinic Cancer Services - Post Falls</name>
      <address>
        <city>Post Falls</city>
        <state>Idaho</state>
        <zip>83854</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Cancer Institute - Twin Falls</name>
      <address>
        <city>Twin Falls</city>
        <state>Idaho</state>
        <zip>83301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>208-381-2774</phone>
      <email>eslinget@slhs.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rush - Copley Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>630-978-6212</phone>
      <email>Cancer.Research@rushcopley.com</email>
    </contact>
    <investigator>
      <last_name>Sinisa Stanic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>312-695-1301</phone>
      <email>cancer@northwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Sean Sachdev</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Illinois</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>312-355-3046</phone>
    </contact>
    <investigator>
      <last_name>Daniel Moreira</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle at The Riverfront</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@Carle.com</email>
    </contact>
    <investigator>
      <last_name>Sinisa Stanic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Cancer Center Kishwaukee</name>
      <address>
        <city>DeKalb</city>
        <state>Illinois</state>
        <zip>60115</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>630-352-5360</phone>
      <email>Donald.Smith3@nm.org</email>
    </contact>
    <investigator>
      <last_name>William F. Hartsell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Effingham</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Sinisa Stanic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Cancer Center Delnor</name>
      <address>
        <city>Geneva</city>
        <state>Illinois</state>
        <zip>60134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>630-352-5360</phone>
      <email>Donald.Smith3@nm.org</email>
    </contact>
    <investigator>
      <last_name>William F. Hartsell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Mattoon/Charleston</name>
      <address>
        <city>Mattoon</city>
        <state>Illinois</state>
        <zip>61938</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Sinisa Stanic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Loyola University Medical Center</name>
      <address>
        <city>Maywood</city>
        <state>Illinois</state>
        <zip>60153</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>708-226-4357</phone>
    </contact>
    <investigator>
      <last_name>Abhishek A. Solanki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Regional Health Center</name>
      <address>
        <city>Mount Vernon</city>
        <state>Illinois</state>
        <zip>62864</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>618-242-4600</phone>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Sinisa Stanic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-446-5532</phone>
      <email>Research@carle.com</email>
    </contact>
    <investigator>
      <last_name>Sinisa Stanic</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwestern Medicine Cancer Center Warrenville</name>
      <address>
        <city>Warrenville</city>
        <state>Illinois</state>
        <zip>60555</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>630-352-5360</phone>
      <email>Donald.Smith3@nm.org</email>
    </contact>
    <investigator>
      <last_name>William F. Hartsell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center - Garden City</name>
      <address>
        <city>Garden City</city>
        <state>Kansas</state>
        <zip>67846</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-948-5588</phone>
      <email>aroland@kccop.org</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center - Great Bend</name>
      <address>
        <city>Great Bend</city>
        <state>Kansas</state>
        <zip>67530</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-948-5588</phone>
      <email>aroland@kccop.org</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Radiation Oncology Resource Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>859-629-7169</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital East</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>859-629-7169</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Jewish Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Suspended</status>
  </location>
  <location>
    <facility>
      <name>MaineHealth Coastal Cancer Treatment Center</name>
      <address>
        <city>Bath</city>
        <state>Maine</state>
        <zip>04530</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>888-823-5923</phone>
      <email>ctsucontact@westat.com</email>
    </contact>
    <investigator>
      <last_name>Matthew D. Cheney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MaineHealth/SMHC Cancer Care and Blood Disorders-Biddeford</name>
      <address>
        <city>Biddeford</city>
        <state>Maine</state>
        <zip>04005</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>LLemire@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Matthew D. Cheney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center-Bramhall Campus</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-885-7565</phone>
    </contact>
    <investigator>
      <last_name>Matthew D. Cheney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MaineHealth Cancer Care Center of York County</name>
      <address>
        <city>Sanford</city>
        <state>Maine</state>
        <zip>04073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-459-1600</phone>
    </contact>
    <investigator>
      <last_name>Matthew D. Cheney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MaineHealth/SMHC Cancer Care and Blood Disorders-Sanford</name>
      <address>
        <city>Sanford</city>
        <state>Maine</state>
        <zip>04073</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>LLemire@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Matthew D. Cheney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center- Scarborough Campus</name>
      <address>
        <city>Scarborough</city>
        <state>Maine</state>
        <zip>04074</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-396-8090</phone>
      <email>wrighd@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Matthew D. Cheney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Maine Medical Partners - South Portland</name>
      <address>
        <city>South Portland</city>
        <state>Maine</state>
        <zip>04106</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>207-396-8670</phone>
      <email>ClinicalResearch@mmc.org</email>
    </contact>
    <investigator>
      <last_name>Matthew D. Cheney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Maryland/Greenebaum Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-888-8823</phone>
    </contact>
    <investigator>
      <last_name>Mark V. Mishra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University/Sidney Kimmel Cancer Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-955-8804</phone>
      <email>jhcccro@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Curtiland Deville</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Suburban Hospital</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>301-896-2719</phone>
      <email>bsquill1@jhmi.edu</email>
    </contact>
    <investigator>
      <last_name>Curtiland Deville</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UM Baltimore Washington Medical Center/Tate Cancer Center</name>
      <address>
        <city>Glen Burnie</city>
        <state>Maryland</state>
        <zip>21061</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>410-553-8100</phone>
    </contact>
    <investigator>
      <last_name>Mark V. Mishra</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology - Burnsville</name>
      <address>
        <city>Burnsville</city>
        <state>Minnesota</state>
        <zip>55337</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital</name>
      <address>
        <city>Coon Rapids</city>
        <state>Minnesota</state>
        <zip>55433</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fairview Southdale Hospital</name>
      <address>
        <city>Edina</city>
        <state>Minnesota</state>
        <zip>55435</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Unity Hospital</name>
      <address>
        <city>Fridley</city>
        <state>Minnesota</state>
        <zip>55432</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fairview Clinics and Surgery Center Maple Grove</name>
      <address>
        <city>Maple Grove</city>
        <state>Minnesota</state>
        <zip>55369</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA-Maplewood</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint John's Hospital - Healtheast</name>
      <address>
        <city>Maplewood</city>
        <state>Minnesota</state>
        <zip>55109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Abbott-Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hennepin County Medical Center</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55415</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Health Partners Inc</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55454</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Monticello Cancer Center</name>
      <address>
        <city>Monticello</city>
        <state>Minnesota</state>
        <zip>55362</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>North Memorial Medical Health Center</name>
      <address>
        <city>Robbinsdale</city>
        <state>Minnesota</state>
        <zip>55422</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Park Nicollet Clinic - Saint Louis Park</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Regions Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>United Hospital</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55102</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Francis Regional Medical Center</name>
      <address>
        <city>Shakopee</city>
        <state>Minnesota</state>
        <zip>55379</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lakeview Hospital</name>
      <address>
        <city>Stillwater</city>
        <state>Minnesota</state>
        <zip>55082</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ridgeview Medical Center</name>
      <address>
        <city>Waconia</city>
        <state>Minnesota</state>
        <zip>55387</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rice Memorial Hospital</name>
      <address>
        <city>Willmar</city>
        <state>Minnesota</state>
        <zip>56201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Minnesota Oncology Hematology PA-Woodbury</name>
      <address>
        <city>Woodbury</city>
        <state>Minnesota</state>
        <zip>55125</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Mississippi Medical Center</name>
      <address>
        <city>Jackson</city>
        <state>Mississippi</state>
        <zip>39216</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Central Care Cancer Center - Bolivar</name>
      <address>
        <city>Bolivar</city>
        <state>Missouri</state>
        <zip>65613</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>913-948-5588</phone>
      <email>aroland@kccop.org</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at West County Hospital</name>
      <address>
        <city>Creve Coeur</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeff M. Michalski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Freeman Health System</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>417-347-4030</phone>
      <email>LJCrockett@freemanhealth.com</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Joplin</name>
      <address>
        <city>Joplin</city>
        <state>Missouri</state>
        <zip>64804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>417-556-3074</phone>
      <email>esmeralda.carrillo@mercy.net</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Delbert Day Cancer Institute at PCRMC</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>573-458-7504</phone>
      <email>research@phelpshealth.org</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Clinic-Rolla-Cancer and Hematology</name>
      <address>
        <city>Rolla</city>
        <state>Missouri</state>
        <zip>65401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>573-458-6379</phone>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Heartland Regional Medical Center</name>
      <address>
        <city>Saint Joseph</city>
        <state>Missouri</state>
        <zip>64506</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>816-271-7937</phone>
      <email>linda.schumacher@mymlc.com</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeff M. Michalski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital South</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63128</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>janet.lesko@mercy.net</email>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center-South County</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63129</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeff M. Michalski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Christian Hospital</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeff M. Michalski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Saint Louis</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63141</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>314-251-7066</phone>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Siteman Cancer Center at Saint Peters Hospital</name>
      <address>
        <city>Saint Peters</city>
        <state>Missouri</state>
        <zip>63376</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-600-3606</phone>
      <email>info@siteman.wustl.edu</email>
    </contact>
    <investigator>
      <last_name>Jeff M. Michalski</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Springfield</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>417-269-4520</phone>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CoxHealth South Hospital</name>
      <address>
        <city>Springfield</city>
        <state>Missouri</state>
        <zip>65807</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>417-269-4520</phone>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-996-2663</phone>
      <email>research@billingsclinic.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bozeman Deaconess Hospital</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59715</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Benefis Healthcare- Sletten Cancer Institute</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Great Falls Clinic</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kalispell Regional Medical Center</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Patrick Hospital - Community Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59802</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-327-3118</phone>
      <email>amy.hanneman@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Community Medical Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHI Health Good Samaritan</name>
      <address>
        <city>Kearney</city>
        <state>Nebraska</state>
        <zip>68847</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>308-865-7963</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alegent Health Immanuel Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-717-1510</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alegent Health Bergan Mercy Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-717-1510</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alegent Health Lakeside Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-717-1510</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Creighton University Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>402-717-1510</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cooper Hospital University Medical Center</name>
      <address>
        <city>Camden</city>
        <state>New Jersey</state>
        <zip>08103</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>856-325-6757</phone>
    </contact>
    <investigator>
      <last_name>Gary Eastwick</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rutgers Cancer Institute of New Jersey</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08903</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>732-235-7356</phone>
    </contact>
    <investigator>
      <last_name>Tina Mayer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Robert Wood Johnson University Hospital Somerset</name>
      <address>
        <city>Somerville</city>
        <state>New Jersey</state>
        <zip>08876</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>908-685-2481</phone>
      <email>Siby.Varughese@rwjbh.org</email>
    </contact>
    <investigator>
      <last_name>Tina Mayer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Community Medical Center</name>
      <address>
        <city>Toms River</city>
        <state>New Jersey</state>
        <zip>08755</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>732-557-8294</phone>
      <email>Lennette.Gonzales@rwjbh.org</email>
    </contact>
    <investigator>
      <last_name>Tina Mayer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center at Cooper-Voorhees</name>
      <address>
        <city>Voorhees</city>
        <state>New Jersey</state>
        <zip>08043</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>856-325-6757</phone>
    </contact>
    <investigator>
      <last_name>Gary Eastwick</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwell Health Imbert Cancer Center</name>
      <address>
        <city>Bay Shore</city>
        <state>New York</state>
        <zip>11706</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>516-734-8896</phone>
    </contact>
    <investigator>
      <last_name>Michael R. Folkert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center-Einstein Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Benjamin A. Gartrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center-Weiler Hospital</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10461</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Benjamin A. Gartrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center - Moses Campus</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>718-379-6866</phone>
      <email>eskwak@montefiore.org</email>
    </contact>
    <investigator>
      <last_name>Benjamin A. Gartrell</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Northwell Health/Center for Advanced Medicine</name>
      <address>
        <city>Lake Success</city>
        <state>New York</state>
        <zip>11042</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>516-734-8896</phone>
    </contact>
    <investigator>
      <last_name>Michael R. Folkert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Union Square</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10003</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-824-7309</phone>
      <email>CCTO@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Bobby Liaw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Chelsea</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10011</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-824-7309</phone>
      <email>CCTO@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Bobby Liaw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai West</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10019</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-824-7309</phone>
      <email>CCTO@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Bobby Liaw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Lenox Hill Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>516-734-8896</phone>
    </contact>
    <investigator>
      <last_name>Michael R. Folkert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-824-7309</phone>
      <email>CCTO@mssm.edu</email>
    </contact>
    <investigator>
      <last_name>Bobby Liaw</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Manhattan Eye Ear and Throat Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>212-434-4460</phone>
    </contact>
    <investigator>
      <last_name>Michael R. Folkert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Phelps Memorial Hospital Center</name>
      <address>
        <city>Sleepy Hollow</city>
        <state>New York</state>
        <zip>10591</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>914-366-1600</phone>
    </contact>
    <investigator>
      <last_name>Michael R. Folkert</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vidant Oncology-Kenansville</name>
      <address>
        <city>Kenansville</city>
        <state>North Carolina</state>
        <zip>28349</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>research@ecuhealth.org</email>
    </contact>
    <investigator>
      <last_name>Misbah U. Qadir</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vidant Oncology-Kinston</name>
      <address>
        <city>Kinston</city>
        <state>North Carolina</state>
        <zip>28501</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>252-559-2201</phone>
      <email>research@ecuhealth.org</email>
    </contact>
    <investigator>
      <last_name>Misbah U. Qadir</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vidant Oncology-Richlands</name>
      <address>
        <city>Richlands</city>
        <state>North Carolina</state>
        <zip>28574</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>research@ecuhealth.org</email>
    </contact>
    <investigator>
      <last_name>Misbah U. Qadir</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Center-UC Medical Center</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Hospital - Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>513-853-1300</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bethesda North Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>513-853-1300</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ohio State University Comprehensive Cancer Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-293-5066</phone>
      <email>Jamesline@osumc.edu</email>
    </contact>
    <investigator>
      <last_name>Shang-Jui Wang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Cincinnati Cancer Center-West Chester</name>
      <address>
        <city>West Chester</city>
        <state>Ohio</state>
        <zip>45069</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>405-271-8777</phone>
      <email>ou-clinical-trials@ouhsc.edu</email>
    </contact>
    <investigator>
      <last_name>Tyler Gunter</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Oklahoma City</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>405-752-3402</phone>
    </contact>
    <investigator>
      <last_name>Jay W. Carlson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saint Charles Health System</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>541-706-2909</phone>
      <email>nosall@stcharleshealthcare.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Clackamas Radiation Oncology Center</name>
      <address>
        <city>Clackamas</city>
        <state>Oregon</state>
        <zip>97015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Cancer Institute Clackamas Clinic</name>
      <address>
        <city>Clackamas</city>
        <state>Oregon</state>
        <zip>97015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bay Area Hospital</name>
      <address>
        <city>Coos Bay</city>
        <state>Oregon</state>
        <zip>97420</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>541-269-8392</phone>
      <email>cherie.cox@bayareahospital.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Legacy Mount Hood Medical Center</name>
      <address>
        <city>Gresham</city>
        <state>Oregon</state>
        <zip>97030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Providence Newberg Medical Center</name>
      <address>
        <city>Newberg</city>
        <state>Oregon</state>
        <zip>97132</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Willamette Falls Medical Center</name>
      <address>
        <city>Oregon City</city>
        <state>Oregon</state>
        <zip>97045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Legacy Good Samaritan Hospital and Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97210</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Saint Vincent Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-215-2614</phone>
      <email>CanRsrchStudies@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>503-494-1080</phone>
      <email>trials@ohsu.edu</email>
    </contact>
    <investigator>
      <last_name>Arthur Y. Hung</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Legacy Meridian Park Hospital</name>
      <address>
        <city>Tualatin</city>
        <state>Oregon</state>
        <zip>97062</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>UPMC Altoona</name>
      <address>
        <city>Altoona</city>
        <state>Pennsylvania</state>
        <zip>16601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC-Heritage Valley Health System Beaver</name>
      <address>
        <city>Beaver</city>
        <state>Pennsylvania</state>
        <zip>15009</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-389-5208</phone>
      <email>haneydl@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Crozer-Keystone Regional Cancer Center at Broomall</name>
      <address>
        <city>Broomall</city>
        <state>Pennsylvania</state>
        <zip>19008</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>610-284-8237</phone>
      <email>Jolene.garney@crozer.org</email>
    </contact>
    <investigator>
      <last_name>Rachelle M. Lanciano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Carlisle Regional Cancer Center</name>
      <address>
        <city>Carlisle</city>
        <state>Pennsylvania</state>
        <zip>17015</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Delaware County Memorial Hospital</name>
      <address>
        <city>Drexel Hill</city>
        <state>Pennsylvania</state>
        <zip>19026</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>610-284-8237</phone>
      <email>jolene.garney@crozer.org</email>
    </contact>
    <investigator>
      <last_name>Rachelle M. Lanciano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center - East Norriton Hospital Outpatient Center</name>
      <address>
        <city>East Norriton</city>
        <state>Pennsylvania</state>
        <zip>19401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Mark A. Hallman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center Erie</name>
      <address>
        <city>Erie</city>
        <state>Pennsylvania</state>
        <zip>16505</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-389-5208</phone>
      <email>haneydl@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Center at UPMC Horizon</name>
      <address>
        <city>Farrell</city>
        <state>Pennsylvania</state>
        <zip>16121</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center Buckingham</name>
      <address>
        <city>Furlong</city>
        <state>Pennsylvania</state>
        <zip>18925</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>215-794-2700</phone>
    </contact>
    <investigator>
      <last_name>Mark A. Hallman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Crozer Regional Cancer Center at Brinton Lake</name>
      <address>
        <city>Glen Mills</city>
        <state>Pennsylvania</state>
        <zip>19342</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>610-284-8237</phone>
    </contact>
    <investigator>
      <last_name>Rachelle M. Lanciano</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Centers - Arnold Palmer Pavilion</name>
      <address>
        <city>Greensburg</city>
        <state>Pennsylvania</state>
        <zip>15601</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>724-838-1900</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Pinnacle Cancer Center/Community Osteopathic Campus</name>
      <address>
        <city>Harrisburg</city>
        <state>Pennsylvania</state>
        <zip>17109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>717-724-6765</phone>
      <email>klitchfield@PINNACLEHEALTH.org</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penn State Milton S Hershey Medical Center</name>
      <address>
        <city>Hershey</city>
        <state>Pennsylvania</state>
        <zip>17033-0850</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>717-531-3779</phone>
      <email>CTO@hmc.psu.edu</email>
    </contact>
    <investigator>
      <last_name>Joseph A. Miccio</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC-Johnstown/John P. Murtha Regional Cancer Center</name>
      <address>
        <city>Johnstown</city>
        <state>Pennsylvania</state>
        <zip>15901</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>814-534-4724</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion</name>
      <address>
        <city>Mechanicsburg</city>
        <state>Pennsylvania</state>
        <zip>17050</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-389-5208</phone>
      <email>haneydl@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Center - Monroeville</name>
      <address>
        <city>Monroeville</city>
        <state>Pennsylvania</state>
        <zip>15146</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Hillman Cancer Center in Coraopolis</name>
      <address>
        <city>Moon</city>
        <state>Pennsylvania</state>
        <zip>15108</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-389-5208</phone>
      <email>haneydl@upmc.edu</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Center-Natrona Heights</name>
      <address>
        <city>Natrona Heights</city>
        <state>Pennsylvania</state>
        <zip>15065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>724-230-3030</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Penn Presbyterian Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>ecog.rss@jimmy.harvard.edu</email>
    </contact>
    <investigator>
      <last_name>Neha Vapiwala</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania/Abramson Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>215-600-9151</phone>
      <email>ONCTrialNow@jefferson.edu</email>
    </contact>
    <investigator>
      <last_name>Jessie W. Dinome</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fox Chase Cancer Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>215-728-4790</phone>
    </contact>
    <investigator>
      <last_name>Mark A. Hallman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>215-728-2983</phone>
    </contact>
    <investigator>
      <last_name>Mark A. Hallman</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC-Magee Womens Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-647-2811</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC-Saint Margaret</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-784-4900</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute (UPCI)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-647-8073</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC-Shadyside Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-621-2334</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC-Passavant Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-367-6454</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC-Saint Clair Hospital Cancer Center</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15243</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>412-502-3920</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Cancer Center at UPMC Northwest</name>
      <address>
        <city>Seneca</city>
        <state>Pennsylvania</state>
        <zip>16346</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>814-676-7900</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Uniontown Hospital Radiation Oncology</name>
      <address>
        <city>Uniontown</city>
        <state>Pennsylvania</state>
        <zip>15401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>724-437-2503</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Washington Hospital Radiation Oncology</name>
      <address>
        <city>Washington</city>
        <state>Pennsylvania</state>
        <zip>15301</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>724-223-3788</phone>
      <email>cancer@washingtonhospital.org</email>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Susquehanna</name>
      <address>
        <city>Williamsport</city>
        <state>Pennsylvania</state>
        <zip>17701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-598-4282</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UPMC Memorial</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17408</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>717-724-6760</phone>
    </contact>
    <investigator>
      <last_name>Adam Olson</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>843-792-9321</phone>
      <email>hcc-clinical-trials@musc.edu</email>
    </contact>
    <investigator>
      <last_name>Harriet B. Eldredge-Hindy</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford Cancer Center Oncology Clinic</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>605-312-3320</phone>
      <email>OncologyClinicTrialsSF@sanfordhealth.org</email>
    </contact>
    <investigator>
      <last_name>Preston D. Steen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sanford USD Medical Center - Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57117-5134</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>605-312-3320</phone>
      <email>OncologyClinicalTrialsSF@SanfordHealth.org</email>
    </contact>
    <investigator>
      <last_name>Preston D. Steen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Simmons Cancer Center - RedBird</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75237</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@utsouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Kevin D. Courtney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Kevin D. Courtney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Fort Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>214-648-7097</phone>
      <email>canceranswerline@UTSouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Kevin D. Courtney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Clinical Center at Richardson/Plano</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>972-669-7044</phone>
      <email>Suzanne.cole@utsouthwestern.edu</email>
    </contact>
    <investigator>
      <last_name>Kevin D. Courtney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Audie L Murphy VA Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-469-5300</phone>
    </contact>
    <investigator>
      <last_name>Michael A. Liss</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>210-450-3800</phone>
      <email>phoresearchoffice@uthscsa.edu</email>
    </contact>
    <investigator>
      <last_name>Michael A. Liss</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University/Massey Cancer Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23298</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <email>CTOclinops@vcu.edu</email>
    </contact>
    <investigator>
      <last_name>Alfredo I. Urdaneta</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Aberdeen</name>
      <address>
        <city>Aberdeen</city>
        <state>Washington</state>
        <zip>98520</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>360-412-8958</phone>
      <email>deidre.dillon@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Saint Joseph Medical Center</name>
      <address>
        <city>Bellingham</city>
        <state>Washington</state>
        <zip>98225</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>360-788-8223</phone>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Harrison Medical Center</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>253-426-6882</phone>
      <email>ResearchInstituteInquiries@CommonSpirit.org</email>
    </contact>
    <investigator>
      <last_name>Shahzad Siddique</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Centralia</name>
      <address>
        <city>Centralia</city>
        <state>Washington</state>
        <zip>98531</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>360-412-8958</phone>
      <email>deidre.dillon@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute-Edmonds</name>
      <address>
        <city>Edmonds</city>
        <state>Washington</state>
        <zip>98026</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>206-215-3086</phone>
      <email>PCRC-NCORP@Swedish.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer Partnership</name>
      <address>
        <city>Everett</city>
        <state>Washington</state>
        <zip>98201</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>425-261-3529</phone>
      <email>marilyn.birchman@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Institute-Issaquah</name>
      <address>
        <city>Issaquah</city>
        <state>Washington</state>
        <zip>98029</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>206-215-3086</phone>
      <email>PCRC-NCORP@Swedish.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Providence Regional Cancer System-Lacey</name>
      <address>
        <city>Lacey</city>
        <state>Washington</state>
        <zip>98503</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>360-412-8958</phone>
      <email>deidre.dillon@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Saint John Medical Center</name>
      <address>
        <city>Longview</city>
        <state>Washington</state>
        <zip>98632</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>360-514-2016</phone>
      <email>kmakin-bond@peacehealth.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center-Ballard Campus</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98107</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>206-215-3086</phone>
      <email>PCRC-NCORP@Swedish.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>FHCC South Lake Union</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-804-8824</phone>
    </contact>
    <investigator>
      <last_name>Jonathan J. Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-804-8824</phone>
    </contact>
    <investigator>
      <last_name>Jonathan J. Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center-First Hill</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>206-215-3086</phone>
      <email>PCRC-NCORP@Swedish.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center - Montlake</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-804-8824</phone>
    </contact>
    <investigator>
      <last_name>Jonathan J. Chen</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>PeaceHealth United General Medical Center</name>
      <address>
        <city>Sedro-Woolley</city>
        <state>Washington</state>
        <zip>98284</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>360-788-8238</phone>
      <email>lkey@peacehealth.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>PeaceHealth Southwest Medical Center</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98664</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>360-514-3940</phone>
      <email>kmakin-bond@peacehealth.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Legacy Cancer Institute Medical Oncology and Day Treatment</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98684</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Legacy Salmon Creek Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>Washington</state>
        <zip>98686</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Providence Saint Mary Regional Cancer Center</name>
      <address>
        <city>Walla Walla</city>
        <state>Washington</state>
        <zip>99362</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>509-897-5993</phone>
      <email>Cheryl.Dodd@providence.org</email>
    </contact>
    <investigator>
      <last_name>Alison K. Conlin</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Langlade Hospital and Cancer Center</name>
      <address>
        <city>Antigo</city>
        <state>Wisconsin</state>
        <zip>54409</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>715-623-9869</phone>
      <email>Juli.Alford@aspirus.org</email>
    </contact>
    <investigator>
      <last_name>Andrew J. Huang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-EC Cancer Center</name>
      <address>
        <city>Eau Claire</city>
        <state>Wisconsin</state>
        <zip>54701</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Isaac K. Yeboah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UW Cancer Center Johnson Creek</name>
      <address>
        <city>Johnson Creek</city>
        <state>Wisconsin</state>
        <zip>53038</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>920-699-3500</phone>
      <email>lynda.persico@uwmf.wisc.edu</email>
    </contact>
    <investigator>
      <last_name>John M. Floberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Wisconsin Carbone Cancer Center</name>
      <address>
        <city>Madison</city>
        <state>Wisconsin</state>
        <zip>53792</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-622-8922</phone>
    </contact>
    <investigator>
      <last_name>John M. Floberg</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Marshfield</name>
      <address>
        <city>Marshfield</city>
        <state>Wisconsin</state>
        <zip>54449</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Isaac K. Yeboah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Clinic-Minocqua Center</name>
      <address>
        <city>Minocqua</city>
        <state>Wisconsin</state>
        <zip>54548</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Isaac K. Yeboah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Western Wisconsin</name>
      <address>
        <city>New Richmond</city>
        <state>Wisconsin</state>
        <zip>54017</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>952-993-1517</phone>
      <email>mmcorc@healthpartners.com</email>
    </contact>
    <investigator>
      <last_name>David M. King</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-Rice Lake</name>
      <address>
        <city>Rice Lake</city>
        <state>Wisconsin</state>
        <zip>54868</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Isaac K. Yeboah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ascension Saint Michael's Hospital</name>
      <address>
        <city>Stevens Point</city>
        <state>Wisconsin</state>
        <zip>54481</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>715-847-2353</phone>
      <email>Beth.Knetter@aspirus.org</email>
    </contact>
    <investigator>
      <last_name>Andrew J. Huang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center-River Region at Stevens Point</name>
      <address>
        <city>Stevens Point</city>
        <state>Wisconsin</state>
        <zip>54482</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Isaac K. Yeboah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aspirus Regional Cancer Center</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>877-405-6866</phone>
    </contact>
    <investigator>
      <last_name>Andrew J. Huang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Marshfield Medical Center - Weston</name>
      <address>
        <city>Weston</city>
        <state>Wisconsin</state>
        <zip>54476</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>800-782-8581</phone>
      <email>oncology.clinical.trials@marshfieldresearch.org</email>
    </contact>
    <investigator>
      <last_name>Isaac K. Yeboah</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aspirus Cancer Care - Wisconsin Rapids</name>
      <address>
        <city>Wisconsin Rapids</city>
        <state>Wisconsin</state>
        <zip>54494</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>715-422-7718</phone>
    </contact>
    <investigator>
      <last_name>Andrew J. Huang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Welch Cancer Center</name>
      <address>
        <city>Sheridan</city>
        <state>Wyoming</state>
        <zip>82801</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Site Public Contact</last_name>
      <phone>406-969-6060</phone>
      <email>mccinfo@mtcancer.org</email>
    </contact>
    <investigator>
      <last_name>John M. Schallenkamp</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>July 20, 2023</last_update_submitted>
  <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leuprolide</mesh_term>
    <mesh_term>Goserelin</mesh_term>
    <mesh_term>Triptorelin Pamoate</mesh_term>
    <mesh_term>Tryptophan</mesh_term>
    <mesh_term>Relugolix</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04423211
org study id: EA8191
secondary id: NCI-2020-02686
secondary id: EA8191
secondary id: EA8191
secondary id: U10CA180820
nct id: NCT04423211
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This phase III trial tests two questions by two separate comparisons of therapies. The first
      question is whether enhanced therapy (apalutamide in combination with abiraterone +
      prednisone) added to standard of care (prostate radiation therapy and short term androgen
      deprivation) is more effective compared to standard of care alone in patients with prostate
      cancer who experience biochemical recurrence (a rise in the blood level of prostate specific
      antigen [PSA] after surgical removal of the prostate cancer).

      A second question tests treatment in patients with biochemical recurrence who show prostate
      cancer spreading outside the pelvis (metastasis) by positron emission tomography (PET)
      imaging. In these patients, the benefit of adding metastasis-directed radiation to enhanced
      therapy (apalutamide in combination with abiraterone + prednisone) is tested.

      Diagnostic procedures, such as PET, may help doctors look for cancer that has spread to the
      pelvis. Androgens are hormones that may cause the growth of prostate cancer cells.
      Apalutamide may help fight prostate cancer by blocking the use of androgens by the tumor
      cells. Metastasis-directed targeted radiation therapy uses high energy rays to kill tumor
      cells and shrink tumors that have spread. This trial may help doctors determine if using PET
      results to deliver more tailored treatment (i.e., adding apalutamide, with or without
      targeted radiation therapy, to standard of care treatment) works better than standard of care
      treatment alone in patients with biochemical recurrence of prostate cancer.
PRIMARY OBJECTIVES:

      I. For patients without PET-evidence of extrapelvic metastases, to evaluate whether the
      addition of enhanced systemic therapy to standard of care (SOC) salvage radiation therapy
      (RT) could prolong progression-free survival (PFS).

      II. For patients with PET-evidence of extrapelvic metastases, to evaluate whether the
      addition of metastasis-directed RT to enhanced systemic therapy and SOC salvage RT could
      prolong PFS.

      III. To compare overall quality of life, measured by Functional Assessment of Cancer Therapy
      - Prostate (FACT-P) total score, at 6 months between the two sets of treatment arms (A with B
      and C with D). (QUALITY OF LIFE [QOL] OBJECTIVE)

      SECONDARY OBJECTIVES:

      I. To evaluate overall survival in each arm. II. To evaluate event-free survival in each arm.
      III. To evaluate time to prostate-specific antigen (PSA) progression in each arm.

      IV. To assess the incidence of adverse events with the addition of enhanced systemic therapy
      in patients without PET-evidence of extrapelvic metastases.

      V. To assess the incidence of adverse events with local ablative metastasis-directed RT for
      PET-positive metastatic disease in patients with PET-evidence of extrapelvic metastases.

      VI. To estimate the detection rate of PET at the patient and regional level, and to evaluate
      its concordance with the follow-up Food and Drug Administration (FDA)-approved conventional
      imaging modalities (CIM) (as available) considered standard-of-care per institution,
      including computed tomography (CT), bone scintigraphy, magnetic resonance imaging (MRI) and
      PET imaging.

      VII. To determine the distribution of PET-positive lesions among anatomic sites (prostate
      fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone
      metastases) in patients with post-radical prostatectomy (RP) biochemical recurrence (BCR),
      correlated with PSA (level, doubling time, velocity) and other relevant clinical parameters.

      VIII. To compare the change in overall QOL, measured by FACT-P total score, from baseline to
      6 months between the two sets of treatment arms (A with B and C with D). (QOL OBJECTIVE) IX.
      To compare patient-reported fatigue (Functional Assessment of Chronic Illness Therapy
      [FACIT]-Fatigue scores) at 6 months between the two sets of treatment arms (A with B and C
      with D). (QOL OBJECTIVE) X. To compare patient-reported overall QOL (FACT-P scores), fatigue
      (FACIT-Fatigue scores) and pain interference (patient reported outcomes measurement
      information system [PROMIS] Pain Interference Short Form 4a) between the two sets of
      treatment arms (A with B and C with D) at the time of disease progression. (QOL OBJECTIVE)

      EXPLORATORY OBJECTIVES:

      I.To determine the value of repeat PET (PET2) at time of second PSA progression, clinical
      concern for progression, or 12 months after completion of enhanced systemic therapy,
      whichever comes first to assess response to therapy (enhanced systemic therapy +/- focal RT
      and/or androgen deprivation therapy [ADT]) compared to available standard response
      assessments (PSA and conventional imaging modalities [CIM]).

      II. To compare cognitive function, measured by FACT - cognitive function (Cog) peritoneal
      cancer index (PCI) and total scores, between the three treatment arms receiving enhanced
      systemic treatment with ADT and apalutamide (Arms B, C, and D) and antiandrogen therapy (ADT)
      alone (Arm A) at 6 and 12 month. (QOL OBJECTIVE) III. To compare the change in cognitive
      function, measured by change in FACT-Cog PCI and total scores, from baseline to 6 and
      baseline to 12 months, between the three treatment arms receiving enhanced systemic treatment
      with ADT and apalutamide (Arms B, C, and D) and ADT alone (Arm A) at 6 and 12 months. (QOL
      OBJECTIVE) IV. To characterize longitudinal change in cognitive function between baseline and
      24 months in patients with prostate cancer receiving treatment for biochemical recurrence
      (BCR) and define clinical and disease related characteristics associated with greater
      cognitive change by the FACT-Cog PCI and total scores. (QOL OBJECTIVE)

      OUTLINE:

      STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C
      or D and receiving fluciclovine F18 intravenously (IV) undergo a repeat PET2 at time of PSA
      progression or clinical concerns for progression or 12 months after completion of enhanced
      systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for
      PET1 do not undergo PET2.

      STEP 1: Patients are randomized to 1 of 4 arms based on results of fluciclovine F18 PET/CT or
      PET/MR in Step 0.

      ARM A (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC external beam
      radiation therapy (EBRT) for 6 months. Patients also receive goserelin acetate subcutaneously
      (SC), leuprolide acetate intramuscularly (IM), triptorelin IM, relugolix orally (PO), or
      degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days
      after start of EBRT. All treatment continues for 6 months in the absence of disease
      progression or unacceptable toxicity.

      ARM B (PET NEGATIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive
      goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as
      in Arm A. Patients also receive apalutamide PO once daily (QD) for 6 months in the absence of
      disease progression or unacceptable toxicity.

      ARM C: (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive
      goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as
      in Arm A. Patients also receive apalutamide PO QD as in Arm B.

      ARM D (PET POSITIVE FOR EXTRA PELVIC-METASTASES): Patients undergo SOC EBRT and receive
      goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as
      in Arm A and apalutamide PO QD as in Arm B. Patients also undergo stereotactic body radiation
      therapy (SBRT) or 3-dimensional (3D) conformal radiation therapy (CRT), intensity-modulated
      radiation therapy (IMRT) (including volume modulated arc therapy [VMAT]), and
      intensity-modulated proton therapy (IMPT) over 3-10 fractions in the absence of disease
      progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up every 3 months for the first 2
      years, every 6 months for years 3-5, and then annually for years 6-10.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-free survival (PFS)
time frame: From randomization to radiographic progression by conventional imaging or positron emission tomography (PET), symptomatic disease or death, whichever occurs first, assessed up to 10 years
description: The power of the PFS analysis is 85% using one-sided 0.025 level stratified logrank test. The overall type I error will be controlled using an O'Brien-Fleming boundary function
measure: PFS prolongation in patients without PET-evidence of extrapelvic metastases
time frame: Up to 10 years
description: Will evaluate whether the addition of enhanced systemic therapy to standard of care salvage therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel with patients with PET-evidence of extrapelvic metastases.
measure: PFS prolongation in patients with PET-evidence of extrapelvic metastases
time frame: Up to 10 years
description: Will evaluate whether the addition of metastasis-directed radiation therapy to standard of care salvage therapy and enhanced systemic therapy could prolong PFS in this patient population. Will be an intention-to-treat analysis of all randomized patients and performed in parallel without patients with PET-evidence of extrapelvic metastases.
measure: Quality of life (QOL)
time frame: Up to 24 months
description: Descriptive statistics will be used to characterize QOL over time in each arm.
measure: Overall survival (OS)
time frame: From randomization to death or date last known alive, assessed up to 10 years
description: Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare OS between the two arms in each cohort.
measure: Event-free survival
time frame: From randomization to radiographic progression by conventional imaging or PET, symptomatic disease, or initiation of new treatment for the disease or death, whichever occurs first, assessed up to 10 years
description: Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare EFS between the two arms in each cohort.
measure: Time to prostate-specific antigen (PSA) progression
time frame: From randomization to documented PSA progression or radiographic progression, whichever occurs first, assessed up to 10 years
description: Patients without any progression will be censored at the date of last disease assessment that shows free of PSA progression. Will be characterized by the method of Kaplan and Meier and a logrank test will be used to compare time to PSA progression between the two arms in each cohort.
measure: Incidence of adverse events
time frame: Up to 10 years
description: Toxicity will be defined using the Common Terminology Criteria for Adverse Events.
measure: Detection rate of fluciclovine F18 (18F-fluciclovine) PET
time frame: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
description: For the detection rate, the proportion of baseline standard of care 18F-fluciclovine PET (PET1) positive results at the patient and regional (prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases) level will be calculated and its 95% confidence interval will be estimated using the Exact method based on the binomial distribution.
measure: Concordance of detection rate with the follow-up conventional imaging modalities (CIM)
time frame: At time of PSA recurrence, as clinically indicated or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
description: Will use Cohen's Kappa coefficient to measure the agreement between dichotomized PET results and the dichotomized CIM results. Baseline CIM comparison will not be performed because as per our study eligibility criteria, baseline CIM will be negative for metastases.
measure: Distribution of 18F-fluciclovine PET-positive lesions among anatomic sites
time frame: Baseline
description: The rate of 18F-fluciclovine PET-positive lesions will be reported for each anatomic site, including prostate fossa, intrapelvic soft tissue/lymph node, extrapelvic soft tissue/lymph node, and bone metastases. Their confidence intervals will be estimated using the Exact method for the binomial distribution. To evaluate if PSA (level, doubling time, velocity) and other relevant clinical parameters affects the positivity distribution, will use the logistic regression to model with the binary outcome (positive vs. negative from PET) and covariates will include anatomic site, PSA, and other clinical parameters. Will test the interactions between anatomic site and PSA (plus other clinical parameters) to see if the positivity distribution across anatomic site may change according to the levels of the interacted terms. Will use the technique of generalized estimating equation to account for the outcome correlations within subjects.
measure: Value of repeat PET to assess response to therapy compared to standard response assessments
time frame: At time of second PSA recurrence or 12 months after completion of enhanced systemic therapy (whichever occurs first), assessed up to 10 years
description: Analyses will be conducted to evaluate qualitative visual evidence of 18F-fluciclovine PET positive metastatic lesions and quantitative PET standardized-uptake value (SUV) changes on a lesion-to-lesion basis from 18F-fluciclovine PET1 (baseline) to PET2 on visually determined sites of recurrence and metastatic disease. This will be compared to reference standard-of-care conventional imaging (Prostate Cancer Working Group 2 criteria) and PSA response at PET2 time point to determine PET2 response to therapy. PET2 visual and quantitative assessment will also be compared to PFS in the time-to-event analysis using a log-rank test (PET2 visual assessment) and a Cox proportional hazards regression (PET2 quantitative assessment). PET SUV parameters to be obtained at PET1 and PET2 will include SUVmax, SUVpeak. PET SUV change from PET1 to PET2 will include absolute SUVmax and SUVpeak change (PET2-PET1) and percent change of SUVmax and SUVpeak (% change = 100*[(PET2-PET1)/PET1]).)
measure: Comparison - Functional Assessment of Cancer Therapy (FACT)- prostate (P)
time frame: At baseline and 3, 6, 9, 12 months
description: For the PET-negative cohort, with 216 analyzable patients in each arm, the study will have about 84% power to detect a 6-point (0.29 standard deviation) difference between the two arms using a two-sample t test with two-sided type I error of 0.05. The power will be greater than 99% if the difference between the two arms is 10 points (0.48 standard deviation). For the PET-positive cohort, with 146 analyzable patients in each arm, the study will have 68% and 98% power to detect a 6-point (0.29 standard deviation) and a 10-point (0.48 standard deviation) differences between the two arms, respectively, using the same test.
measure: Change in FACT-P and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue
time frame: Baseline up to 6 months
description: A paired t test will be used to compare FACT-P scores at these two time points in each arm. A two-sample t test will be performed to compare the changes in FACT-P scores from baseline to 6 months between the two arms of each cohort. The FACIT-Fatigue scores at 6 months will be compared between the two arms of each cohort using a two-sample t test.
measure: QOL Assessments at Progression
time frame: Up to 10 years
description: A paired t test will be used to compare FACT-P total scores, FACIT-Fatigue scores and pain scores at these two time points in each arm. The changes in these scores from baseline to progression will be evaluated in each arm.
measure: FACT- cognitive functioning (Cog)
time frame: Up to 12 months
description: Will be compared between two groups of patients on this study, patients receiving antiandrogen therapy (ADT) + apalutamide (Arms B, C and D) and patients receiving ADT alone (Arm A), at different time points. To ensure similarity of the three arms with systemic treatments (Arms B, C and D), a comparison in FACT-Cog total scores among these three arms will be performed using the Kruskal-Wallis test before combining them together to be compared with Arm A.
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group type: Active Comparator
description: STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET negative for extera pelvic metastases undergo SOC EBRT for 6 months. Patients also receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC for 6 months starting up to 3 months prior to EBRT but no later than 7 days after start of EBRT. All treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group type: Experimental
description: STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET negative for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD for 6 months in the absence of disease progression or unacceptable toxicity.
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group type: Experimental
description: STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A. Patients also receive apalutamide PO QD as in Arm B.
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
arm group type: Experimental
description: STEP 0: Patients undergo SOC PET/CT or PET/MR scan at baseline. Patients randomized to Arms C or D and receiving fluciclovine F18 IV undergo a repeat PET2 at time of PSA progression or clinical concerns for progression or 12 months after completion of enhanced systemic therapy, whichever occurs first. Patients in Arm C or D using another tracer for PET1 do not undergo PET2.
STEP 1: Patients who are PET positive for extra pelvic metastases undergo SOC EBRT and receive goserelin acetate SC, leuprolide acetate IM, triptorelin IM, relugolix PO, or degarelix SC as in Arm A and apalutamide PO QD as in Arm B. Patients also undergo SBRT or 3D CRT, IMRT (including VMAT), and IMPT over 3-10 fractions in the absence of disease progression or unacceptable toxicity.
intervention type: Radiation
intervention name: 3-Dimensional Conformal Radiation Therapy
description: Undergo 3D CRT
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: 3-dimensional radiation therapy
other name: 3D Conformal
other name: 3D CONFORMAL RADIATION THERAPY
other name: 3D CRT
other name: 3D radiotherapy
other name: 3D-CRT
other name: Conformal Therapy
other name: Radiation Conformal Therapy
other name: Radiation, 3D Conformal
other name: Three dimensional external beam radiation therapy (procedure)
intervention type: Drug
intervention name: Apalutamide
description: Given PO
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: ARN 509
other name: ARN-509
other name: ARN509
other name: Erleada
other name: JNJ 56021927
other name: JNJ-56021927
intervention type: Procedure
intervention name: Computed Tomography
description: Undergo PET/CT
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: CAT
other name: CAT Scan
other name: Computed Axial Tomography
other name: Computerized Axial Tomography
other name: Computerized axial tomography (procedure)
other name: Computerized Tomography
other name: CT
other name: CT Scan
other name: tomography
intervention type: Drug
intervention name: Degarelix
description: Given SC
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: FE200486
other name: Firmagon
intervention type: Radiation
intervention name: External Beam Radiation Therapy
description: Undergo EBRT
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: Definitive Radiation Therapy
other name: EBRT
other name: External Beam Radiation
other name: External Beam Radiotherapy
other name: External Beam Radiotherapy (conventional)
other name: External Beam RT
other name: external radiation
other name: External Radiation Therapy
other name: external-beam radiation
other name: Radiation, External Beam
other name: Teleradiotherapy
other name: Teletherapy
other name: Teletherapy Radiation
intervention type: Other
intervention name: Fluciclovine F18
description: Given IV
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: (18F)Fluciclovine
other name: (18F)GE-148
other name: 18F-Fluciclovine
other name: [18F]FACBC
other name: Anti-(18f)FABC
other name: Anti-1-Amino-3-[18F]Fluorocyclobutane-1-Carboxylic Acid
other name: Anti-[18F] FACBC
other name: Axumin
other name: Fluciclovine (18F)
other name: FLUCICLOVINE F-18
other name: GE-148 (18F)
other name: GE-148 F-18
intervention type: Drug
intervention name: Goserelin Acetate
description: Given SC
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: ZDX
other name: Zoladex
intervention type: Procedure
intervention name: Intensity-Modulated Proton Therapy
description: Undergo IMPT
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: IMPT
intervention type: Radiation
intervention name: Intensity-Modulated Radiation Therapy
description: Undergo IMRT
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: IMRT
other name: Intensity modulated radiation therapy (procedure)
other name: Intensity Modulated RT
other name: Intensity-Modulated Radiotherapy
other name: Radiation, Intensity-Modulated Radiotherapy
intervention type: Drug
intervention name: Leuprolide Acetate
description: Given IM
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: A-43818
other name: Abbott 43818
other name: Abbott-43818
other name: Carcinil
other name: Depo-Eligard
other name: Eligard
other name: Enanton
other name: Enantone
other name: Enantone-Gyn
other name: Ginecrin
other name: LEUP
other name: Leuplin
other name: Leuprorelin Acetate
other name: Lucrin
other name: Lucrin Depot
other name: Lupron
other name: Lupron Depot
other name: Lupron Depot-3 Month
other name: Lupron Depot-4 Month
other name: Lupron Depot-Ped
other name: Lutrate
other name: Procren
other name: Procrin
other name: Prostap
other name: TAP-144
other name: Trenantone
other name: Uno-Enantone
other name: Viadur
intervention type: Procedure
intervention name: Magnetic Resonance Imaging
description: Undergo PET/MR
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: Magnetic Resonance
other name: Magnetic resonance imaging (procedure)
other name: Magnetic Resonance Imaging Scan
other name: Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
other name: MR
other name: MR Imaging
other name: MRI
other name: MRI Scan
other name: NMR Imaging
other name: NMRI
other name: Nuclear Magnetic Resonance Imaging
intervention type: Procedure
intervention name: Positron Emission Tomography
description: Undergo PET/CT or PET/MR
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: Medical Imaging, Positron Emission Tomography
other name: PET
other name: PET Scan
other name: Positron emission tomography (procedure)
other name: Positron Emission Tomography Scan
other name: Positron-Emission Tomography
other name: proton magnetic resonance spectroscopic imaging
other name: PT
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: Quality of Life Assessment
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
intervention type: Drug
intervention name: Relugolix
description: Given PO
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea
other name: Orgovyx
other name: TAK 385
other name: TAK-385
intervention type: Radiation
intervention name: Stereotactic Body Radiation Therapy
description: Undergo SBRT
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: SABR
other name: SBRT
other name: Stereotactic Ablative Body Radiation Therapy
intervention type: Drug
intervention name: Triptorelin
description: Given IM
arm group label: Arm A (EBRT, short-term androgen deprivation therapy [STAD])
arm group label: Arm B (EBRT, STAD, apalutamide)
arm group label: Arm C (EBRT, STAD, apalutamide)
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: 6-D-Tryptophan-LH-RH
other name: 6-D-Tryptophanluteinizing Hormone-releasing Factor
other name: AY-25650
other name: CL-118,532
other name: Detryptoreline
intervention type: Radiation
intervention name: Volume Modulated Arc Therapy
description: Undergo VMAT
arm group label: Arm D (EBRT, STAD, apalutamide, RT)
other name: VMAT
other name: Volumetric Modulated Arc Therapy (procedure)
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Neha Vapiwala
role: Principal Investigator
affiliation: ECOG-ACRIN Cancer Research Group
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facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Suspended
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Recruiting
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facility: 
status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Active, not recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Not yet recruiting
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investigator: 
facility: 
status: Not yet recruiting
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investigator: 
facility: 
status: Not yet recruiting
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investigator: 
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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status: Recruiting
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country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Prostatic Neoplasms
mesh term: Leuprolide
mesh term: Goserelin
mesh term: Triptorelin Pamoate
mesh term: Tryptophan
mesh term: Relugolix