Loading clinical trials...

Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency | Clinical Trials | Clareo Health

TERMINATEDPHASE2

Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency

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

NCT03442556•University of Washington

View on ClinicalTrials.gov

Summary

This phase II trial studies how well docetaxel with carboplatin followed by rucaparib camsylate works in treating patients with metastatic castration resistant prostate cancer (spread outside of prostate and resistant to testosterone suppression) with homologous recombination DNA repair deficiency. Chemotherapy drugs, such as docetaxel and carboplatin, work to stop the growth of cancer cells, by stopping them from dividing or spreading. Rucaparib camsylate may stop the growth of tumor cells with defects in the ability to repair mistakes in DNA by forcing additional errors so that the cancer cells cannot overcome the number of errors and will then die. Giving induction docetaxel and carboplatin followed by maintenance rucaparib camsylate may work better in treating patients with castration resistant prostate cancer.

Detailed Description

OUTLINE: 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.

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Signed informed consent form (ICF) providing agreement to adhere to the dosing schedule, report for all trial visits and authorization, use and release of health and research trial information
•Histologically or cytologically confirmed adenocarcinoma of the prostate (excluding predominant small cell histology)
•Ongoing gonadal androgen deprivation therapy with gonadotropin-releasing hormone (GnRH) analogues, antagonists or orchiectomy; patients who have not had an orchiectomy must be maintained on effective GnRH analogue/antagonist therapy
•Castration resistant prostate cancer as defined by serum testosterone \< 50 ng/ml and PSA level of at least 2 ng/ml that has risen on at least 2 successive occasions at least 1 week apart
•Presence of metastatic disease on bone or computed tomography (CT) scan
•* Evaluable disease progression by modified RECIST 1.1 (Response Evaluation Criteria in Solid Tumors)
•* Bone disease on bone scan
•Prior therapy with sipuleucel-T, abiraterone, enzalutamide, docetaxel, and/or cabazitaxel; there is no limit to the number of prior treatment regimens in the castration resistant setting, so long as prior therapy does not include platinum chemotherapy or a PARP inhibitor; prior platinum chemotherapy in the hormone sensitive setting is permitted, so long as it has been at least 6 months since last dose
•Eastern Cooperative Oncology Group (ECOG) performance status of =\< 1
•Life expectancy \>= 12 weeks
+17 more criteria

Exclusion Criteria

•Currently receiving active therapy for other neoplastic disorders
•Symptomatic and/or untreated central nervous system (CNS) metastases; patients with asymptomatic previously treated CNS metastases are eligible provided they have been clinically stable for at least 4 weeks
•Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, active or symptomatic viral hepatitis or chronic liver disease
•Clinically significant heart disease as evidenced by myocardial infarction, or arterial thrombotic events in the past 6 months, severe or unstable angina, or New York Heart Association (NYHA) class II-IV heart disease or cardiac ejection fraction measurement of \< 35 % at baseline
•Treatment with an investigational therapeutic drug within 30 days of cycle 1
•Prior therapy with a PARP inhibitor (e.g., olaparib, talazoparib, veliparib, niraparib, rucaparib)
•Prior therapy with a platinum chemotherapy (e.g. cisplatin, carboplatin, oxaliplatin) in the castration resistant setting; (prior platinum chemotherapy in the hormone sensitive setting is permitted, so long as time since last dose is 6 months or greater)
•Active, ongoing toxicity (Common Terminology Criteria for Adverse Events \[CTCAE\] grade 2 or higher) from prior therapy
•Presence of dementia, psychiatric illness, and/or social situations limiting compliance with study requirements or understanding and/or giving of informed consent
•Pre-existing duodenal stent and/ or any gastrointestinal disorder or defect that would, in the opinion of the Investigator, interfere with absorption of rucaparib
+1 more criteria

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

August 24, 2018

Primary Completion Date

June 4, 2025

Completion Date

June 4, 2025

Last Updated

June 12, 2025

Enrollment

ACTUAL participants

Conditions

ATM Gene MutationBRCA1 Gene MutationBRCA2 Gene MutationCastration Levels of TestosteroneCastration-Resistant Prostate CarcinomaHomologous Recombination DeficiencyProstate Carcinoma Metastatic in the BonePSA Level Greater Than or Equal to TwoPSA ProgressionStage IV Prostate Adenocarcinoma AJCC v7

Interventions

Carboplatin

DRUG

Docetaxel

DRUG

Laboratory Biomarker Analysis

OTHER

Rucaparib Camsylate

DRUG

Rucaparib

DRUG

TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

NCT04294927

BRCA1 Gene MutationBRCA2 Gene Mutation+4 more

View study

RECRUITINGPHASE2

Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability

NCT03428802

BRCA1 Gene MutationBRCA2 Gene Mutation+18 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 12, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency

Inclusion Criteria

Exclusion Criteria

TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

Pembrolizumab in Treating Participants With Metastatic, Recurrent or Locally Advanced Cancer and Genomic Instability

Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery

Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

Pilot Study of Curcumin for Women With Obesity and High Risk for Breast Cancer