Summary

for males ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

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.

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

Keywords

Metastatic Castration Resistant Prostate Cancer CRPC PARP inhibitor PARPi BRCA ATM HRD TRITON homologous recombination DNA repair DNA defect DNA anomaly germline somatic mCRPC Prostatic Neoplasms Docetaxel Abiraterone Acetate Rucaparib Abiraterone acetate or Enzalutamide or Docetaxel

Eligibility

You can join if…

Open to males ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCSF Helen Diller Family Comprehensive Cancer Center accepting new patients
    San Francisco California 94158 United States
  • Pacific Hematology Oncology Associates accepting new patients
    San Francisco California 94115 United States
  • San Francisco VA Health Care System accepting new patients
    San Francisco California 94121 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Clovis Oncology, Inc.
ID
NCT02975934
Phase
Phase 3
Study Type
Interventional
Last Updated