<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/NCT02985021</url>
  </required_header>
  <id_info>
    <org_study_id>PugetSoundVA</org_study_id>
    <nct_id>NCT02985021</nct_id>
  </id_info>
  <brief_title>Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies</brief_title>
  <official_title>A Phase 2 Study of Docetaxel and Carboplatin for Treatment of Patients With Metastatic, Castration Resistant Prostate Cancer and Germline or Somatic DNA Repair Deficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Institute for Biomedical and Clinical Research</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Prostate Cancer Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>VA Puget Sound Health Care System</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Seattle Institute for Biomedical and Clinical Research</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study, patients who have metastatic prostate cancer that does not respond to hormone&#xD;
      treatment and who have mutations in certain cancer-related genes will be treated with&#xD;
      docetaxel and carboplatin chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a phase 2 study of the combination of docetaxel and carboplatin in patients with&#xD;
      germline inactivation of genes in the homologous recombination pathway, including BRCA1,&#xD;
      BRCA2, and Ataxia Telangiectasia Mutated (ATM).&#xD;
&#xD;
      PRIMARY OBJECTIVE To assess rate of 50% Prostate Specific Androgen (PSA) decline to docetaxel&#xD;
      and carboplatin&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Competing studies&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">April 2021</completion_date>
  <primary_completion_date type="Actual">April 2021</primary_completion_date>
  <phase>Phase 2</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>Percentage of Patients Achieving &gt;= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria</measure>
    <time_frame>From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)</time_frame>
    <description>Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Hormone-Resistant Prostate Cancer</condition>
  <condition>Metastatic Prostate Carcinoma</condition>
  <condition>Recurrent Prostate Carcinoma</condition>
  <condition>Stage IV Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Treatment (docetaxel, carboplatin)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.&#xD;
Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Chemotherapy</description>
    <arm_group_label>Treatment (docetaxel, carboplatin)</arm_group_label>
    <other_name>Paraplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Chemotherapy</description>
    <arm_group_label>Treatment (docetaxel, carboplatin)</arm_group_label>
    <other_name>Taxotere</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Patients meeting the following inclusion criteria will be eligible to participate in this&#xD;
        study:&#xD;
&#xD;
          1. Signed informed consent form (ICF) providing agreement to adhere to the dosing&#xD;
             schedule, report for all trial visits and authorization, use and release of health and&#xD;
             research trial information.&#xD;
&#xD;
          2. Age &gt; 18 years&#xD;
&#xD;
          3. Known prostate cancer&#xD;
&#xD;
          4. Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone&#xD;
             (GnRH) analogues, antagonists or orchiectomy. Patients who have not had an orchiectomy&#xD;
             must be maintained on effective GnRH analogue/antagonist therapy.&#xD;
&#xD;
          5. Castration resistant prostate cancer as defined by serum testosterone &lt; 50ng/ml and&#xD;
             one of the following:&#xD;
&#xD;
               -  PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions&#xD;
                  at least 1 week apart.&#xD;
&#xD;
               -  Evaluable disease progression by modified RECIST (Response Evaluation Criteria in&#xD;
                  Solid Tumors).&#xD;
&#xD;
               -  Progression of metastatic bone disease on bone scan with &gt; 2 new lesions.&#xD;
&#xD;
          6. Prior therapy with abiraterone acetate, enzalutamide, or docetaxel. There is no limit&#xD;
             to the number of prior treatment regimens.&#xD;
&#xD;
          7. Presence of metastatic disease on scans.&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2.&#xD;
&#xD;
          9. Life expectancy &gt;12 weeks.&#xD;
&#xD;
         10. No prior malignancy is allowed except:&#xD;
&#xD;
               -  Adequately treated basal cell or squamous cell skin cancer or&#xD;
&#xD;
               -  In situ carcinoma of any site or&#xD;
&#xD;
               -  Other adequately treated malignancy for which the patient has been disease-free&#xD;
                  for at least one year (any prior chemotherapy is allowed).&#xD;
&#xD;
         11. Patients must have adequate organ and marrow function as defined below obtained within&#xD;
             14 days prior to start of therapy:&#xD;
&#xD;
               1. Absolute neutrophil count &gt;1.5 x 109 cells/L&#xD;
&#xD;
               2. Hgb &gt; 9.0 g/dL&#xD;
&#xD;
               3. Platelets &gt;100,000 x 109/L&#xD;
&#xD;
               4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total&#xD;
                  bilirubin levels &lt; 1.5 x Upper Limit of Normal (ULN)&#xD;
&#xD;
         12. Presence of germline inactivation of BRCA1, BRCA2, ATM OR one of the following:&#xD;
&#xD;
               -  Patients with clearly deleterious germline mutations of other genes involved in&#xD;
                  homologous DNA repair may be included at the investigator's discretion.&#xD;
&#xD;
               -  Patients with homozygous inactivation of genes involved in homologous&#xD;
                  recombination from primary or metastatic tumor as assessed by a Clinical&#xD;
                  Laboratory Improvement Amendments (CLIA) level assay for DNA sequencing may be&#xD;
                  included.&#xD;
&#xD;
               -  Patients with a signature of homologous recombination deficiency in primary or&#xD;
                  metastatic tissue may be included (VA Puget Sound only).&#xD;
&#xD;
        Exclusion Criteria&#xD;
&#xD;
        Patients who meet any of the following criteria will be excluded from the study:&#xD;
&#xD;
          1. Currently receiving active therapy for other neoplastic disorders.&#xD;
&#xD;
          2. Histologic evidence of small cell carcinoma (morphology alone - immunohistochemical&#xD;
             evidence of neuroendocrine differentiation without morphologic evidence is not&#xD;
             exclusionary).&#xD;
&#xD;
          3. Prior treatment with platinum-based chemotherapy for prostate cancer.&#xD;
&#xD;
          4. Known parenchymal brain metastasis.&#xD;
&#xD;
          5. Active or symptomatic viral hepatitis or chronic liver disease.&#xD;
&#xD;
          6. Clinically significant heart disease as evidenced by myocardial infarction, or&#xD;
             arterial thrombotic events in the past 6 months, severe or unstable angina, or New&#xD;
             York Heart Association (NYHA) Class II-IV heart disease or cardiac ejection fraction&#xD;
             measurement of &lt; 35 % at baseline, if done.&#xD;
&#xD;
          7. Treatment with an investigational therapeutic within 30 days of Cycle 1.&#xD;
&#xD;
          8. Patients with dementia/psychiatric illness/social situations limiting compliance with&#xD;
             study requirements or understanding and/or giving of informed consent are not eligible&#xD;
&#xD;
          9. Any medical conditions, which, in the opinion of the investigators, would jeopardize&#xD;
             either the patient or the integrity of the data obtained are not eligible.&#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>Robert B Montgomery, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Puget Sound HCS</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Matthew Rettig, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Greater Los Angeles HCS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Greater Los Angeles - West LA</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Ann Arbor Health Care System</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA Puget Sound Health Care System</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 4, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <results_first_submitted>April 19, 2021</results_first_submitted>
  <results_first_submitted_qc>August 3, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 5, 2021</results_first_posted>
  <last_update_submitted>August 3, 2021</last_update_submitted>
  <last_update_submitted_qc>August 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2021</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>
    <mesh_term>DNA Repair-Deficiency Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT02985021/Prot_SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 27, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/21/NCT02985021/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Treatment (Docetaxel, Carboplatin)</title>
          <description>Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.&#xD;
Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.&#xD;
Carboplatin: Chemotherapy&#xD;
Docetaxel: Chemotherapy</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Inability to comply with study procedures</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Patients with metastatic, resistant prostate cancer</population>
      <group_list>
        <group group_id="B1">
          <title>Treatment (Docetaxel, Carboplatin)</title>
          <description>Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.&#xD;
Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.&#xD;
Carboplatin: Chemotherapy&#xD;
Docetaxel: Chemotherapy</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="2"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Patients with metastatic resistant prostate cancer</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Patients Achieving &gt;= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria</title>
        <description>Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy</description>
        <time_frame>From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Treatment (Docetaxel, Carboplatin)</title>
            <description>Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.&#xD;
Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.&#xD;
Carboplatin: Chemotherapy&#xD;
Docetaxel: Chemotherapy</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients Achieving &gt;= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria</title>
          <description>Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy (30 weeks))</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Treatment (Docetaxel, Carboplatin)</title>
          <description>Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.&#xD;
Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.&#xD;
Carboplatin: Chemotherapy&#xD;
Docetaxel: Chemotherapy</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="2"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Bruce Montgomery, PI</name_or_title>
      <organization>VA Puget Sound HCS</organization>
      <phone>2062776878</phone>
      <email>rbmontgo@uw.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02985021
org study id: PugetSoundVA
nct id: NCT02985021
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
In this study, patients who have metastatic prostate cancer that does not respond to hormone
      treatment and who have mutations in certain cancer-related genes will be treated with
      docetaxel and carboplatin chemotherapy.
This is a phase 2 study of the combination of docetaxel and carboplatin in patients with
      germline inactivation of genes in the homologous recombination pathway, including BRCA1,
      BRCA2, and Ataxia Telangiectasia Mutated (ATM).

      PRIMARY OBJECTIVE To assess rate of 50% Prostate Specific Androgen (PSA) decline to docetaxel
      and carboplatin
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Percentage of Patients Achieving >= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria
time frame: From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)
description: Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy
arm group label: Treatment (docetaxel, carboplatin)
arm group type: Experimental
description: Docetaxel 60 mg/m2 will be administered on Day 1 of each 21-day cycle. Carboplatin Area Under the Curve (AUC) 5 will be administered on Day 1 of each 21-day cycle.
Docetaxel and carboplatin should be administered per institutional guidelines. Treatment will be repeated until disease progression or unacceptable toxicity.
intervention type: Drug
intervention name: Carboplatin
description: Chemotherapy
arm group label: Treatment (docetaxel, carboplatin)
other name: Paraplatin
intervention type: Drug
intervention name: Docetaxel
description: Chemotherapy
arm group label: Treatment (docetaxel, carboplatin)
other name: Taxotere
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert B Montgomery, MD
role: Principal Investigator
affiliation: VA Puget Sound HCS
last name: Matthew Rettig, MD
role: Principal Investigator
affiliation: VA Greater Los Angeles HCS
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Prostatic Neoplasms
mesh term: DNA Repair-Deficiency Disorders
mesh term: Carboplatin
mesh term: Docetaxel
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 