<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/NCT04506567</url>
  </required_header>
  <id_info>
    <org_study_id>20-01021288</org_study_id>
    <nct_id>NCT04506567</nct_id>
  </id_info>
  <brief_title>Fractionated and Multiple Dose 225Ac-J591 for Progressive mCRPC</brief_title>
  <official_title>Phase I/II Dose-escalation Study of Fractionated and Multiple Dose 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the initial (phase I) portion of this study is to find a dose level and&#xD;
      administration schedule of the study drug, 225Ac-J591, that can be given without severe side&#xD;
      effects. The purpose of the second (phase II) portion of the study is to determine the&#xD;
      proportion of those with PSMA-positive tumors with &gt;50% PSA decline following 225Ac-J591&#xD;
      treatment in two regimens.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This clinical trial is for men with progressive metastatic castration resistant prostate&#xD;
      cancer. The purpose of this study is to find the highest dose level of the study drug,&#xD;
      225Ac-J591, that can be given without severe side effects. The research study is being done&#xD;
      because the standard treatments for prostate cancer that has spread beyond the prostate gland&#xD;
      are intended to minimize the adverse effects of the disease. These treatments, however, are&#xD;
      not curative. Patients who choose to participate in this study will have a screening visit to&#xD;
      determine whether or not they are eligible to participate in the study. The treatment phase&#xD;
      is comprised of 8 weeks for the fractionated dose cohort (starting from cycle 1, day 1). For&#xD;
      the multiple-dose cohort, the dose-limiting toxicity evaluation period is from date of first&#xD;
      treatment through treatment on cycle 3, day 1. Following treatment, short-term follow up is&#xD;
      planned until radiographic progression, expected to be 6 months.The study medication is&#xD;
      called 225Ac-J591, and will be administered as a single fractionated cycle day 1 and day 15&#xD;
      in the fractionated dose regimen and as a single dose per cycle repeated every 6 weeks in the&#xD;
      multiple dose regimen. Upon completion of investigational treatment with 225Ac-J591, subjects&#xD;
      will undergo 68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to&#xD;
      document treatment response. 68Ga-PSMA-HBED-CC is comprised of gallium-68, which is a&#xD;
      positron-emitting radionuclide linked to PSMA-HBED-CC (aka PSMA11), which is a small molecule&#xD;
      targeting PSMA. 68Ga-PSMA-HBED-CC will be administered intravenously prior to PET/CT at&#xD;
      screening and at follow up imaging x2. Subsequent survival data and additional treatment(s)&#xD;
      information will be captured from their routine standard of care (SOC) visits. During the&#xD;
      other study visits, participants will undergo routine tests and procedures, such as physical&#xD;
      examinations, and blood tests. Some blood tests will be done for research purposes only.&#xD;
      After completion of therapy, participants may be contacted on a periodic basis to see how&#xD;
      they are doing.&#xD;
&#xD;
      Key eligibility:&#xD;
&#xD;
        -  Open to men age 18 and older.&#xD;
&#xD;
        -  Diagnosis of progressive metastatic prostate cancer&#xD;
&#xD;
        -  Have been previously treated for their disease with particular types of therapy&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 18, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2027</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>In schema 1 (dose-fractionated cohort), subject enrollment will be done in a fractionated dose-escalation study design at each dose level with treatment during one cycle to be administered on Day 1 and Day 15.&#xD;
In schema 2 (multiple dose cohort), subject enrollment will be done in a dose-escalation single dose study design at each dose level with treatment administered as a single dose per cycle every 6 weeks up to 4 cycles. Additional patients will be enrolled at lower doses previously shown to have efficacy (cohorts -1 and -2). The rationale for enrollment of patients at these lower dosing cohorts is to determine whether a smaller number of cycles at higher radioactivity is superior, inferior, or no different than a larger number of cycles at a lower dose.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects with dose limiting toxicity (DLT)</measure>
    <time_frame>Will be collected at the time of visit 1 through end of study or 100 months</time_frame>
    <description>DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cumulative maximum tolerated dose (MTD)</measure>
    <time_frame>Will be collected at the time of visit 1 through end of study or 100 months</time_frame>
    <description>The dose that produces an &quot;acceptable&quot; level of toxicity or that, if exceeded, would put subjects at &quot;unacceptable&quot; risk for toxicity. MTD is defined as the dose level at which no more than two patients out of six experienced dose-limiting toxicity (DLT).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the recommended phase II dose (RP2D) of 225Ac-J591 in fractionated dose and multiple dose regimens (phase I)</measure>
    <time_frame>Will be collected at the time of visit 1 through end of study or 100 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Assess the proportion of those with PSMA+ tumors with &gt;50% PSA decline following 225Ac-J591 in two regimens (phase II)</measure>
    <time_frame>Will be collected at the time of visit 1 through end of study or 100 months</time_frame>
    <description>Proportion of patients achieving 50% or greater PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of subjects with radiographic response</measure>
    <time_frame>Scans will be performed at screening, day 85, then again at end of study or 100 months</time_frame>
    <description>Response evaluation criteria in solid tumors RECIST (Version 1.1) criteria with prostate cancer working group 3 (PCWG3) modifications will be used</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival following fractionated dose and multiple doses of 225Ac-J591</measure>
    <time_frame>Survival will be collected from Day 1 through study completion up to 100 months</time_frame>
    <description>Overall survival will be captured through in-clinic or telephone contact with subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment</measure>
    <time_frame>Scans will be performed at screening, day 85 and day 168</time_frame>
    <description>68Ga-PSMA-11 PET/CT will be utilized as part of the radiographic assessment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in circulating tumor cells (CTC) and the rate of favorable and undetectable CTC count at 12 weeks following 225Ac-J591</measure>
    <time_frame>Samples will be collected at screening, day 1, day 85 and at disease progression</time_frame>
    <description>CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of treatment and adverse event rate</measure>
    <time_frame>Will be collected at the time of visit 1 through end of study or 100 months</time_frame>
    <description>National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess biochemical progression-free survival</measure>
    <time_frame>Will be collected at the time of visit 1 through end of study or 100 months</time_frame>
    <description>PSA progression will be defined as a rise of &gt; 25% above either the pretreatment level or the nadir PSA level (whichever is lowest). PSA must increase by &gt; 2 ng/ml to be considered progression</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assess the proportion with different levels of PSA decline following 225Ac-J591</measure>
    <time_frame>Will be collected at the time of visit 1 through end of study or 100 months</time_frame>
    <description>PSA will be monitored through serial blood draws. Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">105</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Dose- Fractionated Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive a single cycle of 225Ac-J591, administered as a fractionated dose on days 1 and 15. This is a dose-escalation design, with up to 4 dosing cohorts.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multiple Dose Cohort</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will receive 225Ac-J591 every 6 weeks, with up to 4 doses. Some patients will be enrolled in a dose-escalation design, with up to 3 dosing cohorts. Additional patients will be enrolled at 2 lower dosing-cohorts.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>225Ac-J591</intervention_name>
    <description>Single cycle of fractionated dose of 225Ac-J591</description>
    <arm_group_label>Dose- Fractionated Cohort</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>68Ga-PSMA-HBED-CC injection</intervention_name>
    <description>68Ga-PSMA-HBED-CC PET/CT before and after treatment</description>
    <arm_group_label>Dose- Fractionated Cohort</arm_group_label>
    <arm_group_label>Multiple Dose Cohort</arm_group_label>
    <other_name>68Ga-PSMA-11</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>225Ac-J591</intervention_name>
    <description>Single dose of 225Ac-J591 every 6 weeks x 4</description>
    <arm_group_label>Multiple Dose Cohort</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed adenocarcinoma of prostate&#xD;
&#xD;
          2. Documented progressive metastatic CRPC based on Prostate Cancer Working&#xD;
&#xD;
             Group 3 (PCWG3) criteria, which includes at least one of the following criteria:&#xD;
&#xD;
               -  PSA progression&#xD;
&#xD;
               -  Objective radiographic progression in soft tissue&#xD;
&#xD;
               -  New bone lesions&#xD;
&#xD;
          3. Have serum testosterone &lt; 50 ng/dL. Subjects must continue primary androgen&#xD;
             deprivation with an LHRH/GnRH analogue (agonist/antagonist) if they have not undergone&#xD;
             orchiectomy&#xD;
&#xD;
          4. Have previously been treated with at least one of the following in any disease state:&#xD;
&#xD;
               -  Androgen receptor signaling inhibitor (such as enzalutamide)&#xD;
&#xD;
               -  CYP 17 inhibitor (such as abiraterone acetate)&#xD;
&#xD;
          5. Have previously received taxane chemotherapy (in any disease state), been determined&#xD;
             to be ineligible for taxane chemotherapy by their physician, or refused taxane&#xD;
             chemotherapy.&#xD;
&#xD;
          6. Age &gt; 18 years&#xD;
&#xD;
          7. Patients must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  Absolute neutrophil count &gt;2,000 cells/mm3&#xD;
&#xD;
               -  Hemoglobin ≥9 g/dL&#xD;
&#xD;
               -  Platelet count &gt;150,000 x 109/uL&#xD;
&#xD;
               -  Serum creatinine &lt;1.5 x upper limit of normal (ULN) or calculated creatinine&#xD;
                  clearance ≥ 60 mL/min/1.73 m2 by Cockcroft-Gault&#xD;
&#xD;
               -  Serum total bilirubin &lt;1.5 x ULN (unless due to Gilbert's Syndrome in which case&#xD;
                  direct bilirubin must be normal)&#xD;
&#xD;
               -  Serum AST and ALT &lt;3 x ULN in absence of liver metastases; &lt; 5x ULN if due to&#xD;
                  liver metastases (in both circumstances bilirubin must meet entry criteria)&#xD;
&#xD;
          8. ECOG performance status of 0-2&#xD;
&#xD;
          9. Ability to understand and the willingness to sign a written informed consent document&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
          1. Implantation of investigational medical device ≤4 weeks of Treatment Visit 1 (Day 1)&#xD;
             or current enrollment in oncologic investigational drug or device study&#xD;
&#xD;
          2. Use of investigational drugs ≤4 weeks or &lt;5 half-lives of Cycle 1, Day 1 or current&#xD;
             enrollment in investigational oncology drug or device study&#xD;
&#xD;
          3. Prior systemic beta-emitting bone-seeking radioisotopes&#xD;
&#xD;
          4. Known active brain metastases or leptomeningeal disease&#xD;
&#xD;
          5. History of deep vein thrombosis and/or pulmonary embolus within 1 month of C1D1&#xD;
&#xD;
          6. Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or&#xD;
             hematological organ systems which might preclude completion of this study or interfere&#xD;
             with determination of causality of any adverse effects experienced in this study&#xD;
&#xD;
          7. Radiation therapy for treatment of PC ≤4 weeks of Day 1 Cycle 1&#xD;
&#xD;
          8. Patients on stable dose of bisphosphonates or denosumab, which have been started no&#xD;
             less than 4 weeks prior to treatment start, may continue on this medication, however&#xD;
             patients are not allowed to initiate bisphosphonate/Denosumab therapy during the&#xD;
             DLT-assessment period of the study&#xD;
&#xD;
          9. Having partners of childbearing potential and not willing to use a method of birth&#xD;
             control deemed acceptable by the principle investigator and chairperson during the&#xD;
             study and for 1 month after last study drug administration&#xD;
&#xD;
         10. Currently active other malignancy other than non-melanoma skin cancer. Patients are&#xD;
             considered not to have &quot;currently active&quot; malignancy if they have completed any&#xD;
             necessary therapy and are considered by their physician to be at less than 30% risk of&#xD;
             relapse&#xD;
&#xD;
         11. Known history of myelodysplastic syndrome&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Adult male patients of &gt;18 years age with documented progressive metastatic CRPC</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Joseph R Osborne, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Weill Medical College of Cornell University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>GU Onc Research Team</last_name>
    <phone>212-746-1480</phone>
    <email>guonc@med.cornell.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brooklyn Methodist Hospital - New York Presbyterian</name>
      <address>
        <city>Brooklyn</city>
        <state>New York</state>
        <zip>11215</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lina Flores, RN</last_name>
      <phone>646-923-5883</phone>
      <email>lif9061@nyp.org</email>
    </contact>
    <investigator>
      <last_name>David M Nanus, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medicine</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>GU Onc Research Team</last_name>
      <phone>212-746-1480</phone>
      <email>guonc@med.cornell.edu</email>
    </contact>
    <investigator>
      <last_name>Joseph R Osborne, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 24, 2023</last_update_submitted>
  <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 28, 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>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gallium 68 PSMA-11</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04506567
org study id: 20-01021288
nct id: NCT04506567
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of the initial (phase I) portion of this study is to find a dose level and
      administration schedule of the study drug, 225Ac-J591, that can be given without severe side
      effects. The purpose of the second (phase II) portion of the study is to determine the
      proportion of those with PSMA-positive tumors with >50% PSA decline following 225Ac-J591
      treatment in two regimens.
This clinical trial is for men with progressive metastatic castration resistant prostate
      cancer. The purpose of this study is to find the highest dose level of the study drug,
      225Ac-J591, that can be given without severe side effects. The research study is being done
      because the standard treatments for prostate cancer that has spread beyond the prostate gland
      are intended to minimize the adverse effects of the disease. These treatments, however, are
      not curative. Patients who choose to participate in this study will have a screening visit to
      determine whether or not they are eligible to participate in the study. The treatment phase
      is comprised of 8 weeks for the fractionated dose cohort (starting from cycle 1, day 1). For
      the multiple-dose cohort, the dose-limiting toxicity evaluation period is from date of first
      treatment through treatment on cycle 3, day 1. Following treatment, short-term follow up is
      planned until radiographic progression, expected to be 6 months.The study medication is
      called 225Ac-J591, and will be administered as a single fractionated cycle day 1 and day 15
      in the fractionated dose regimen and as a single dose per cycle repeated every 6 weeks in the
      multiple dose regimen. Upon completion of investigational treatment with 225Ac-J591, subjects
      will undergo 68Ga-PSMA-HBED-CC injection and same day PET/CT at the end of study visit to
      document treatment response. 68Ga-PSMA-HBED-CC is comprised of gallium-68, which is a
      positron-emitting radionuclide linked to PSMA-HBED-CC (aka PSMA11), which is a small molecule
      targeting PSMA. 68Ga-PSMA-HBED-CC will be administered intravenously prior to PET/CT at
      screening and at follow up imaging x2. Subsequent survival data and additional treatment(s)
      information will be captured from their routine standard of care (SOC) visits. During the
      other study visits, participants will undergo routine tests and procedures, such as physical
      examinations, and blood tests. Some blood tests will be done for research purposes only.
      After completion of therapy, participants may be contacted on a periodic basis to see how
      they are doing.

      Key eligibility:

        -  Open to men age 18 and older.

        -  Diagnosis of progressive metastatic prostate cancer

        -  Have been previously treated for their disease with particular types of therapy
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: In schema 1 (dose-fractionated cohort), subject enrollment will be done in a fractionated dose-escalation study design at each dose level with treatment during one cycle to be administered on Day 1 and Day 15.
In schema 2 (multiple dose cohort), subject enrollment will be done in a dose-escalation single dose study design at each dose level with treatment administered as a single dose per cycle every 6 weeks up to 4 cycles. Additional patients will be enrolled at lower doses previously shown to have efficacy (cohorts -1 and -2). The rationale for enrollment of patients at these lower dosing cohorts is to determine whether a smaller number of cycles at higher radioactivity is superior, inferior, or no different than a larger number of cycles at a lower dose.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects with dose limiting toxicity (DLT)
time frame: Will be collected at the time of visit 1 through end of study or 100 months
description: DLTs will be measured by utilizing the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
measure: Cumulative maximum tolerated dose (MTD)
time frame: Will be collected at the time of visit 1 through end of study or 100 months
description: The dose that produces an "acceptable" level of toxicity or that, if exceeded, would put subjects at "unacceptable" risk for toxicity. MTD is defined as the dose level at which no more than two patients out of six experienced dose-limiting toxicity (DLT).
measure: Assess the recommended phase II dose (RP2D) of 225Ac-J591 in fractionated dose and multiple dose regimens (phase I)
time frame: Will be collected at the time of visit 1 through end of study or 100 months
measure: Assess the proportion of those with PSMA+ tumors with >50% PSA decline following 225Ac-J591 in two regimens (phase II)
time frame: Will be collected at the time of visit 1 through end of study or 100 months
description: Proportion of patients achieving 50% or greater PSA decline (relative to baseline/pre-treatment PSA). Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.
measure: Number of subjects with radiographic response
time frame: Scans will be performed at screening, day 85, then again at end of study or 100 months
description: Response evaluation criteria in solid tumors RECIST (Version 1.1) criteria with prostate cancer working group 3 (PCWG3) modifications will be used
measure: Overall survival following fractionated dose and multiple doses of 225Ac-J591
time frame: Survival will be collected from Day 1 through study completion up to 100 months
description: Overall survival will be captured through in-clinic or telephone contact with subjects
measure: Change in disease assessment with 68Ga-PSMA-11 PET/CT prior to and following investigational treatment
time frame: Scans will be performed at screening, day 85 and day 168
description: 68Ga-PSMA-11 PET/CT will be utilized as part of the radiographic assessment.
measure: Change in circulating tumor cells (CTC) and the rate of favorable and undetectable CTC count at 12 weeks following 225Ac-J591
time frame: Samples will be collected at screening, day 1, day 85 and at disease progression
description: CTCs will be analyzed through blood specimen collection via CellSearch methodology lab testing
measure: Safety of treatment and adverse event rate
time frame: Will be collected at the time of visit 1 through end of study or 100 months
description: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 is used to grade all adverse events
measure: Assess biochemical progression-free survival
time frame: Will be collected at the time of visit 1 through end of study or 100 months
description: PSA progression will be defined as a rise of > 25% above either the pretreatment level or the nadir PSA level (whichever is lowest). PSA must increase by > 2 ng/ml to be considered progression
measure: Assess the proportion with different levels of PSA decline following 225Ac-J591
time frame: Will be collected at the time of visit 1 through end of study or 100 months
description: PSA will be monitored through serial blood draws. Response may occur at any time following treatment initiation and prior to going off study or initiation of new therapy.
arm group label: Dose- Fractionated Cohort
arm group type: Experimental
description: Patients will receive a single cycle of 225Ac-J591, administered as a fractionated dose on days 1 and 15. This is a dose-escalation design, with up to 4 dosing cohorts.
arm group label: Multiple Dose Cohort
arm group type: Experimental
description: Patients will receive 225Ac-J591 every 6 weeks, with up to 4 doses. Some patients will be enrolled in a dose-escalation design, with up to 3 dosing cohorts. Additional patients will be enrolled at 2 lower dosing-cohorts.
intervention type: Drug
intervention name: 225Ac-J591
description: Single cycle of fractionated dose of 225Ac-J591
arm group label: Dose- Fractionated Cohort
intervention type: Diagnostic Test
intervention name: 68Ga-PSMA-HBED-CC injection
description: 68Ga-PSMA-HBED-CC PET/CT before and after treatment
arm group label: Dose- Fractionated Cohort
arm group label: Multiple Dose Cohort
other name: 68Ga-PSMA-11
intervention type: Drug
intervention name: 225Ac-J591
description: Single dose of 225Ac-J591 every 6 weeks x 4
arm group label: Multiple Dose Cohort
criteria: 
gender: Male
gender based: Yes
gender description: Adult male patients of >18 years age with documented progressive metastatic CRPC
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Joseph R Osborne, MD
role: Principal Investigator
affiliation: Weill Medical College of Cornell University
last name: GU Onc Research Team
phone: 212-746-1480
email: guonc@med.cornell.edu
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Gallium 68 PSMA-11
sharing ipd: No