Docetaxel and Carboplatin for Patients With mCRPC and DNA-Repair Deficiencies

Phase 2

Terminated

• Conditions: Recurrent Prostate Carcinoma; Hormone-Resistant Prostate Cancer; Stage IV Prostate Cancer; Metastatic Prostate Carcinoma
• Interventions: Drug: Carboplatin; Drug: Docetaxel

• Registration Number: NCT02985021
• Lead Sponsor: Seattle Institute for Biomedical and Clinical Research

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 Description

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

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-12-04
• Study First Posted: 2016-12-07
• Primary Completion: 2021-04
• Study Completion: 2021-04
• Results First Submitted: 2021-04-19
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-03
• Last Update Submitted: 2021-08-03
• Results First Posted: 2021-08-05
• Last Update Posted: 2021-08-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment (docetaxel, carboplatin)	Docetaxel	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.
Treatment (docetaxel, carboplatin)	Carboplatin	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Patients Achieving >= 50% Reduction in PSA According to Prostate Cancer Working Group 3 (PCWG3) Criteria	From Day 1 of treatment and up to 30 days after completion of treatment (typically up to 10 cycles of chemotherapy)	Achievement of a PSA50 decline is whether the treatment results in a 50% or greater decline in PSA from baseline PSA prior to therapy

Trial Locations

Locations (3)

VA Greater Los Angeles - West LA; 🇺🇸 Los Angeles, California, United States

VA Puget Sound Health Care System; 🇺🇸 Seattle, Washington, United States

VA Ann Arbor Health Care System; 🇺🇸 Ann Arbor, Michigan, United States