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

P

pharmaand

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)

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

Trial documents
2

Trial contacts and locations

150

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Data sourced from clinicaltrials.gov

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