<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/NCT02242773</url>
  </required_header>
  <id_info>
    <org_study_id>20140372</org_study_id>
    <secondary_id>1R01CA189295-01</secondary_id>
    <nct_id>NCT02242773</nct_id>
  </id_info>
  <brief_title>MRI Based Active Selection for Treatment Trial</brief_title>
  <acronym>MAST</acronym>
  <official_title>MRI-Guided Active Selection for Treatment of Prostate Cancer: The Miami MAST Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Miami</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along&#xD;
      with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would&#xD;
      be likely to require treatment earlier.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 12, 2014</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of Disease Progression within the first two surveillance biopsies</measure>
    <time_frame>24 months</time_frame>
    <description>To determine if multiparametric MRI and MRI-US fusion biopsies increase the rate of progression (conversion to treatment) within the first two non-diagnostic biopsies after undergoing active surveillance as compared to historical cohorts using standard ultrasound guided biopsies.&#xD;
Progression refers to a repeat surveillance biopsy indicating any one of the following:&#xD;
More than 4 positive cores involving any grade of cancer,&#xD;
At least two core with Gleason 3+4 cancer,&#xD;
Any single core with Gleason 4+3 cancer or higher,&#xD;
A Gleason 3+3 at diagnosis that is upgraded to Gleason 3+4, or&#xD;
Undergoing treatment, regardless of histological progression.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time-to-Biochemical Recurrence</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>The investigators will use recurrence after primary therapy to identify whether earlier identification of progression with MRI and MRI-US fusion biopsy will portend less recurrence compared to historical patients undergoing delayed primary surgery or radiation after initial surveillance. Biochemical recurrence (BCR) is defined as PSA of 0.2 or higher on two or more separate measures after surgery or an increase of nadir + 2ng/ml or more after radiation. Time-to-BCR is defined as duration between date of treatment and date of BCR if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life Scores: EPIC SF-12</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) will be used to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health-Related Quality of Life Scores: MAX-PC</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) will be used to measure anxiety from pre-treatment to post-treatment. The scale consists of 18 items (e.g. &quot;I thought about prostate cancer even though I didn't mean to.&quot;) scored on a scale from 0 (&quot;not at all&quot;) to 3 (&quot;often&quot;). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under Receiver Operating Characteristic (ROC) curve</measure>
    <time_frame>Up to 36 months</time_frame>
    <description>The investigators will assess the incremental benefit of mpMRI, genomic risk test, and molecular markers compared to baseline NCCN risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curve will be used to evaluate the performance of NCCN risk and other variables (MRI, genomic testing, and molecular markers) for predicting progression on surveillance. Participants will be categorized at baseline by NCCN risk class ranging from very low risk to intermediate risk; and into those who progressed while on the trial.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">207</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Active Surveillance</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Multi-Parametric MRI</intervention_name>
    <description>Multi-Parametric MRI</description>
    <arm_group_label>Active Surveillance</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MRI-Guided Biopsy</intervention_name>
    <description>MRI-Guided Biopsy</description>
    <arm_group_label>Active Surveillance</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Biopsy confirmed adenocarcinoma of the prostate within 18 months prior to enrollment;&#xD;
&#xD;
          2. Pre-enrollment prostate biopsy must consist of at least 8 cores;&#xD;
&#xD;
          3. Biopsy reviewed by a University of Miami Pathologist;&#xD;
&#xD;
          4. Serum Prostate-Specific Antigen (PSA) ≤ 20 ng/ml within 3 months of study enrollment;&#xD;
&#xD;
          5. Age ≥ 35 and ≤ 85 years;&#xD;
&#xD;
          6. Ability to understand and willingness to sign a written informed consent document;&#xD;
&#xD;
          7. Patients must agree to undergo serial multiparametric MRI and MRI-guided biopsy;&#xD;
&#xD;
          8. Patients must agree to fill out the longitudinal psychosocial questionnaires assessing&#xD;
             health related quality of life.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Greater than 4 cores positive, of any Gleason score, on the University of Miami (UM)&#xD;
             review,&#xD;
&#xD;
          2. Greater than 2 cores positive for Gleason 3+4 cancer,&#xD;
&#xD;
          3. Gleason 4+3 or higher cancer in any single biopsy core.&#xD;
&#xD;
          4. Extracapsular extension suspected on digital rectal exam with confirmation on MRI.&#xD;
             Suspicion of extracapsular extension on MRI alone is not an exclusion for study&#xD;
             enrollment.&#xD;
&#xD;
          5. Subject is not a candidate for multiparametric MRI with contrast. Some reasons may&#xD;
             include (but are not limited to): renal insufficiency, foreign body or pacemakers.&#xD;
&#xD;
          6. No prior pelvic radiotherapy.&#xD;
&#xD;
          7. No prior surgery to the prostate, other than transurethral procedures for benign&#xD;
             prostatic hyperplasia (e.g., transurethral resection, green light laser treatment).&#xD;
&#xD;
          8. No concurrent, active malignancy, other than non-metastatic skin cancer of any type,&#xD;
             superficial bladder cancer, or early stage chronic lymphocytic leukemia&#xD;
             (well-differentiated small cell lymphocytic lymphoma) or &lt;stage IV follicular&#xD;
             lymphoma. If a prior malignancy is in remission for ≥ 3 years then the patient is&#xD;
             eligible.&#xD;
&#xD;
          9. Bilateral hip replacement.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sanoj Punnen, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Miami</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Miami</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 17, 2014</study_first_posted>
  <last_update_submitted>June 30, 2023</last_update_submitted>
  <last_update_submitted_qc>June 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Miami</investigator_affiliation>
    <investigator_full_name>Sanoj Punnen, MD, MAS</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Active Surveillance</keyword>
  <keyword>MRI-Guided Biopsy</keyword>
  <keyword>Multi-parametric MRI</keyword>
  <keyword>MP-MRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_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/NCT02242773
org study id: 20140372
secondary id: 1R01CA189295-01
nct id: NCT02242773
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The main purpose of this study is to determine if Magnetic Resonance Imaging (MRI), along
      with MRI targeted biopsy of suspicious lesions, is of value in detecting patients who would
      be likely to require treatment earlier.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Rate of Disease Progression within the first two surveillance biopsies
time frame: 24 months
description: To determine if multiparametric MRI and MRI-US fusion biopsies increase the rate of progression (conversion to treatment) within the first two non-diagnostic biopsies after undergoing active surveillance as compared to historical cohorts using standard ultrasound guided biopsies.
Progression refers to a repeat surveillance biopsy indicating any one of the following:
More than 4 positive cores involving any grade of cancer,
At least two core with Gleason 3+4 cancer,
Any single core with Gleason 4+3 cancer or higher,
A Gleason 3+3 at diagnosis that is upgraded to Gleason 3+4, or
Undergoing treatment, regardless of histological progression.
measure: Time-to-Biochemical Recurrence
time frame: Up to 36 months
description: The investigators will use recurrence after primary therapy to identify whether earlier identification of progression with MRI and MRI-US fusion biopsy will portend less recurrence compared to historical patients undergoing delayed primary surgery or radiation after initial surveillance. Biochemical recurrence (BCR) is defined as PSA of 0.2 or higher on two or more separate measures after surgery or an increase of nadir + 2ng/ml or more after radiation. Time-to-BCR is defined as duration between date of treatment and date of BCR if BCR occurs. The investigators will follow participants who have progressed and gone on to treatment.
measure: Health-Related Quality of Life Scores: EPIC SF-12
time frame: Up to 36 months
description: Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Expanded Prostate Cancer Index Composite and Medical Outcomes Study SF-12 (EPIC SF-12) will be used to evaluate patient function and satisfaction after prostate cancer treatment. Response options for each item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
measure: Health-Related Quality of Life Scores: MAX-PC
time frame: Up to 36 months
description: Health-Related Quality of Life will be assessed using scores from validated questionnaires. The Memorial Anxiety Scale for Prostate Cancer (MAX-PC) will be used to measure anxiety from pre-treatment to post-treatment. The scale consists of 18 items (e.g. "I thought about prostate cancer even though I didn't mean to.") scored on a scale from 0 ("not at all") to 3 ("often"). Total scores range from 0 to 54, with higher scores indicating higher levels of anxiety.
measure: Area under Receiver Operating Characteristic (ROC) curve
time frame: Up to 36 months
description: The investigators will assess the incremental benefit of mpMRI, genomic risk test, and molecular markers compared to baseline NCCN risk classification for predicting progression on active surveillance. Area under the receiver operating characteristic Curve (ROC) curve will be used to evaluate the performance of NCCN risk and other variables (MRI, genomic testing, and molecular markers) for predicting progression on surveillance. Participants will be categorized at baseline by NCCN risk class ranging from very low risk to intermediate risk; and into those who progressed while on the trial.
arm group label: Active Surveillance
arm group type: Experimental
description: Participants in this group will receive a Multi-Parametric Magnetic Resonance Imaging (MP-MRI) of the prostate/pelvis and MRI-guided prostate biopsy at baseline (0-3 months from enrollment) and at the 12th, 24th and 36th month follow up.
intervention type: Device
intervention name: Multi-Parametric MRI
description: Multi-Parametric MRI
arm group label: Active Surveillance
intervention type: Device
intervention name: MRI-Guided Biopsy
description: MRI-Guided Biopsy
arm group label: Active Surveillance
criteria: 
gender: Male
minimum age: 35 Years
maximum age: 85 Years
healthy volunteers: No
last name: Sanoj Punnen, MD, MAS
role: Principal Investigator
affiliation: University of Miami
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Miami
investigator full name: Sanoj Punnen, MD, MAS
investigator title: Associate Professor
mesh term: Prostatic Neoplasms
sharing ipd: No