Studienregister

Studienregister der Deutschen Gesellschaft für Urologie e.V.

TRITON 3_CO-338-063

AcronymISRCTNEudraCTClinicaltrials.govDRKS
CO-338-0632016-003163-20NCT02975934

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

Status: Active

Purpose / Objectives

Primary Outcome

Radiographic Progression-free Survival (rPFS) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) 

Secondary Outcomes

  1. Objective Response Rate (ORR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  2. Duration of Response (DOR) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  3. Time to Prostate Specific Antigen (PSA) Progression [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  4. PSA Response [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  5. Change in Patient-reported Outcome (PRO) [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  6. 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) ]
  7. Overall Survival [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  8. Trough plasma PK (Cmin) of rucaparib based on sparse sampling [ Time Frame: From enrollment to primary completion of study (up to approximately 5 years) ]
  9. 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) ]
    Composite assessment of treatment-emergent AEs, including laboratory abnormalities, vital sign abnormalities, electrocardiogram (ECG) abnormalities, physical examination abnormalities and ECOG abnormalities

Diagnosis

Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

Patient attributes

Stage

mCRCP

Age

18-

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

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

  • Phase III
  • Multicenter
  • Randomized
  • Two-arm
  • Open Label

Intervention

Arm A

Experimental: Rucaparib

Oral rucaparib (monotherapy).
Drug: Rucaparib
Rucaparib will be administered daily.
Other Name: CO-338
 
Arm B
Active Comparator: Abiraterone acetate or Enzalutamide or Docetaxel
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
 
Drug: Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Other Name: Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)

Documents (password protected)

Responsibilities in overall trial

Clovis Oncology, Inc.

  • Tel. 303 625 5000
  • Fax 303 245 0360

Sponsor representative

BSc, MB ChB, MRCP, FFPM Lindsey Rolfe

    National Coordinating Investigator

    PD Dr. Axel Merseburger

    Monitoring

    Novella Clinical

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