Clinical Trial: Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:

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 ATM.

PRIMARY OBJECTIVE To assess rate of 50% Prostate Specific Androgen (PSA) decline to docetaxel and carboplatin

EXPLORATORY OBJECTIVES To assess PSA response duration to docetaxel and carboplatin To assess response of measurable disease To assess time to progression of bone lesions or measurable disease (RECIST) To assess response to docetaxel and carboplatin in patients with germline alterations or somatic alterations of DNA repair pathway genes (BRCA1, BRCA2, ATM)


Sponsor: Seattle Institute for Biomedical and Clinical Research

Current Primary Outcome: Percentage of patients achieving >= 50% reduction in PSA according to Prostate Cancer Working Group 3 (PCWG3) criteria [ Time Frame: After 10 cycles (210 days), or more per Investigator discretion, or until disease progression or unacceptable toxicity. ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • PSA response duration to docetaxel and carboplatin [ Time Frame: After 10 cycles (210 days), or more per Investigator discretion, or until disease progression or unacceptable toxicity. ]
  • Response of measurable disease [ Time Frame: After 10 cycles (210 days), or more per Investigator discretion, or until disease progression or unacceptable toxicity. ]
  • Time to progression of bone lesions or measurable disease [ Time Frame: After 10 cycles (210 days), or more per Investigator discretion, or until disease progression or unacceptable toxicity. ]
  • Proportion of patients responding to docetaxel and carboplatin who have germline alterations or somatic alterations of DNA repair pathway genes (BRCA1, BRCA2, ATM). [ Time Frame: After 10 cycles (210 days), or more per Investigator discretion, or until disease progression or unacceptable toxicity. ]
  • Correlation between the presence of DNA repair pathway mutations and copy number alterations in cell free DNA [ Time Frame: After 10 cycles (210 days), or more per Investigator discretion, or until disease progression or unacceptable toxicity. ]


Original Secondary Outcome: Same as current

Information By: Seattle Institute for Biomedical and Clinical Research

Dates:
Date Received: November 22, 2016
Date Started: November 2016
Date Completion:
Last Updated: December 15, 2016
Last Verified: December 2016