Rucaparib Vs Physician's Choice of Therapy for Prostate Cancer

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

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Walton, Sherri

    Trial Phone: 321.841.1907

  • IRB No: 17.007.01

    Protocol Abbrev: TRITON 3: CO-338-063

    Principal Investigator: Julio J. Hajdenberg, MD

    Sub Investigators: Landau, Daniel MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: TRITON3: CO-338-063

    Treatment: Medication

    Applicable Disease Sites: Metastatic Castration Resistant Prostate Cancer

    Therapies Involved: Rucaparib/ Abiraterone acetate or Enzalutamide or Docetaxel ID: NCT02975934

  • Objective

    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 verses treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

  • Key Eligibility

    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
    •  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