Description:
The purpose of this study is to determine how patients with metastatic castration-resistant
prostate cancer, and evidence of a homologous recombination gene deficiency, respond to
treatment with rucaparib versus treatment with physician's choice of abiraterone acetate,
enzalutamide, or docetaxel.
Title
- Brief Title: A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
- Official Title: TRITON3: A Multicenter, Randomized, Open Label Phase 3 Study of Rucaparib Versus Physician's Choice of Therapy for Patients With Metastatic Castration Resistant Prostate Cancer Associated With Homologous Recombination Deficiency
Clinical Trial IDs
- ORG STUDY ID:
CO-338-063
- NCT ID:
NCT02975934
Conditions
- Metastatic Castration Resistant Prostate Cancer
Interventions
| Drug | Synonyms | Arms |
|---|
| Rucaparib | CO-338 | Rucaparib |
| Abiraterone acetate or Enzalutamide or Docetaxel | Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel) | Abiraterone acetate or Enzalutamide or Docetaxel |
Purpose
The purpose of this study is to determine how patients with metastatic castration-resistant
prostate cancer, and evidence of a homologous recombination gene deficiency, respond to
treatment with rucaparib versus treatment with physician's choice of abiraterone acetate,
enzalutamide, or docetaxel.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Rucaparib | Experimental | Oral rucaparib (monotherapy). | |
| Abiraterone acetate or Enzalutamide or Docetaxel | Active Comparator | Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone). | - Abiraterone acetate or Enzalutamide or Docetaxel
|
Eligibility Criteria
Inclusion Criteria:
- Be 18 years old at the time the informed consent is signed
- Have a histologically or cytologically confirmed adenocarcinoma or poorly
differentiated carcinoma of the prostate that is metastatic
- Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL
(1.73 nM)
- Be eligible for treatment with physician's choice of comparator treatment (abiraterone
acetate, enzalutamide or docetaxel)
- Experienced disease progression after having received 1 prior next generation androgen
receptor-targeted therapy for castration-resistant disease
- Have a deleterious mutation in a BRCA1/2 or ATM gene
Exclusion Criteria:
- Active second malignancy, with the exception of curatively treated non melanoma skin
cancer, carcinoma in situ, or superficial bladder cancer
- Prior treatment with any PARP inhibitor
- Prior treatment with chemotherapy for metastatic castration-resistant prostate cancer
- Symptomatic and/or untreated central nervous system metastases
- Pre-existing duodenal stent and/or any gastrointestinal disorder or defect that would,
in the opinion of the investigator, interfere with absorption of study drug
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Male |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Radiographic Progression-free Survival (rPFS) |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
Secondary Outcome Measures
| Measure: | Objective Response Rate (ORR) |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Duration of Response (DOR) |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Time to Prostate Specific Antigen (PSA) Progression |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | PSA Response |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Change in Patient-reported Outcome (PRO) |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Clinical Benefit Rate (CBR), defined as the percentage of patients with a complete response (CR), partial response (PR), and stable disease (SD) according to modified RECIST Version 1.1 with no progression in bone per PCWG3 criteria |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Overall Survival |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Trough plasma PK (Cmin) of rucaparib based on sparse sampling |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | |
| Measure: | Number of participants with Adverse Events (AEs) as a measure of safety and tolerability |
| Time Frame: | From enrollment to primary completion of study (up to approximately 5 years) |
| Safety Issue: | |
| Description: | Composite assessment of treatment-emergent AEs, including laboratory abnormalities, vital sign abnormalities, electrocardiogram (ECG) abnormalities, physical examination abnormalities and ECOG abnormalities |
Details
| Phase: | Phase 3 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | Clovis Oncology, Inc. |
Trial Keywords
- CRPC
- PARP inhibitor
- PARPi
- BRCA
- ATM
- HRD
- TRITON
- homologous recombination
- DNA repair
- DNA defect
- DNA anomaly
- germline
- somatic
- mCRPC
Last Updated
July 15, 2021
