NCT03442556

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

Type	Name	Description
DRUG	Carboplatin	Given IV
DRUG	Docetaxel	Given IV
OTHER	Laboratory Biomarker Analysis	Correlative studies
DRUG	Rucaparib Camsylate	Given PO
DRUG	Rucaparib	Given PO

Timeline

• Start date: 2018-08-24
• Primary completion: 2025-06-04
• Completion: 2025-06-04
• First posted: 2018-02-22
• Last updated: 2025-06-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study