Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03442556|
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : May 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|ATM Gene Mutation BRCA1 Gene Mutation BRCA2 Gene Mutation Castration Levels of Testosterone Castration-Resistant Prostate Carcinoma Homologous Recombination Deficiency Prostate Carcinoma Metastatic in the Bone PSA Level Greater Than or Equal to Two PSA Progression Stage IV Prostate Adenocarcinoma AJCC v7||Drug: Carboplatin Drug: Docetaxel Other: Laboratory Biomarker Analysis Drug: Rucaparib Camsylate Drug: Rucaparib||Phase 2|
I. To determine radiographic progression free survival with 4 cycles of docetaxel with carboplatin followed by maintenance rucaparib camsylate (rucaparib) in the treatment of patients with metastatic castration resistant prostate cancer with homologous recombination DNA repair deficiency.
I. To assess maximal prostate-specific antigen (PSA) response to induction docetaxel and carboplatin.
II. To assess PSA response to switch maintenance with rucaparib. III. To assess PSA response duration to docetaxel and carboplatin followed by switch maintenance with rucaparib.
IV. To assess time to PSA progression with induction docetaxel and carboplatin followed by maintenance with rucaparib.
V. To assess response of measurable disease.
INDUCTION: Patients receive docetaxel intravenously (IV) and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive rucaparib camsylate orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PLATI-PARP: A Phase 2 Study of Induction Docetaxel and Carboplatin Followed by Maintenance Rucaparib in Treatment of Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency|
|Actual Study Start Date :||August 24, 2018|
|Estimated Primary Completion Date :||May 15, 2025|
|Estimated Study Completion Date :||May 15, 2025|
Experimental: Treatment (docetaxel, carboplatin, rucaparib camsylate)
INDUCTION: Patients receive docetaxel IV and carboplatin IV on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive rucaparib camsylate PO BID on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Other: Laboratory Biomarker Analysis
Drug: Rucaparib Camsylate
- Radiographic progression free survival assessed by assessment using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1/Prostate Cancer Working Group 3 (PCWG3) criteria [ Time Frame: From first dose of docetaxel/carboplatin to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, assessed up to 6 years ]
- Overall response rate (ORR) of measurable disease (PCWG3) (complete response or partial response) assessed by modified RECIST version 1.1 criteria [ Time Frame: Up to 6 years ]
- Prostate-specific antigen (PSA) nadir after induction [ Time Frame: Up to 6 years ]Rate of confirmed PSA decrease from baseline, assessed by a local laboratory (PSA50 and PSA90)
- PSA nadir after maintenance [ Time Frame: Up to 6 years ]Rate of confirmed PSA decrease from baseline, assessed by a local laboratory (PSA50 and PSA90)
- PSA response duration [ Time Frame: From the date that a response (PSA decrease >= 50%) is first reported to the time that PSA progression is first documented, assessed up to 6 years ]
- Time to PSA progression (PCWG3) [ Time Frame: From first dose of docetaxel/carboplatin to the date that a >= 25% increase and absolute increase of >= 2 ng/mL above the nadir (or baseline value for patients who did not have a decline in PSA) in PSA was measured, assessed up to 6 years ]The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442556
|Contact: Heather H. Chengfirstname.lastname@example.org|
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium||Recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Heather H. Cheng 206-606-1406 email@example.com|
|Principal Investigator: Heather H. Cheng|
|Principal Investigator:||Heather H. Cheng||Fred Hutch/University of Washington Cancer Consortium|