A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3)

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Status and phase: Active, not recruiting; Phase 3

Conditions: Metastatic Castration Resistant Prostate Cancer

Treatments: Drug: Abiraterone acetate or Enzalutamide or Docetaxel; Drug: Rucaparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02975934

CO-338-063

Details and patient eligibility

About

The purpose of this study is to determine how participants 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.

Enrollment: 405 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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405 participants in 2 patient groups

Rucaparib

Experimental group

Description:

Oral rucaparib (monotherapy).

Treatment:

Drug: Rucaparib

Abiraterone acetate or Enzalutamide or Docetaxel

Active Comparator group

Description:

Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).

Treatment:

Drug: Abiraterone acetate or Enzalutamide or Docetaxel