A study to evaluate Rucaparib versus physician’s choice of therapy in patients with metastatic castration-resistant 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 - TRITON3

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-003163-20-IE

Enrollment

400

Registered

2017-03-14

Start date

2017-06-19

Completion date

Unknown

Last updated

2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic castration-resistant prostate cancer MedDRA version: 21.1 Level: PT Classification code 10036909 Term: Prostate cancer metastatic System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: LLT Classification code 10076506 Term: Castration-resistant prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Rubraca 200mg film-coated tablets Product Name: Rucaparib 200mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Rucaparib CAS Number: 283173-50-2 Current Sponsor code: CO-338

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. Be 18 years old at the time the informed consent is signed 2. Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate that is metastatic 3. Be surgically or medically castrated, with serum testosterone levels of = 50 ng/dL (1.73 nM) 4. Be eligible for treatment with physician's choice of comparator treatment 5. Experienced of disease progression after treatment with 1 prior next generation AR targeted therapy (abiraterone acetate, enzalutamide, apalutamide or investigational AR targeted agent) for castration resistant disease 6. Have a deleterious mutation in BRCA1/2 or ATM Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 240

Exclusion criteria

Exclusion criteria: 1. Active second malignancy, with the exception of curatively treated non melanoma skin cancer, carcinoma in situ, or superficial bladder cancer 2. Prior treatment with any PARP inhibitor 3. Prior treatment with chemotherapy for mCRPC 4. Symptomatic and/or untreated central nervous system metastases 5. 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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy of rucaparib versus physician’s choice of treatment based on radiographic progression free survival (rPFS) in metastatic castration-resistant prostate cancer (mCRPC) patients with Homologous Recombination Deficiency (HRD) who progressed on prior AR-directed therapy and have not yet received chemotherapy in the castration-resistant setting.;Secondary Objective: • To assess overall survival (OS) • To assess objective response rate (ORR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in patients with measurable (nodal or visceral) disease • To assess duration of response (DOR) using modified RECIST Version 1.1 in patients with measurable (nodal or visceral) disease • To assess time to PSA progression • To assess PSA response = 50% (all patients) • To assess PSA response = 90% (all patients) • To evaluate Patient-reported Outcome (PRO) using the following instruments: - EuroQol 5 dimensions 5 level questionnaire (EQ-5D-5L) - Functional Assessment of Cancer Therapy–Prostate (FACT-P) - Analgesic drug score - Brief Pain Inventory–Short Form (BPI-SF) instruments • To assess clinical benefit rate (CBR) • To assess sparse pharmacokinetics (PK) • To assess safety and tolerability;Primary end point(s): Efficacy of rucaparib versus physician’s choice of treatment based on radiographic progression free survival (rPFS) in mCRPC patients with HRD who progressed on prior AR-directed therapy and have not yet received chemotherapy in the castration-resistant setting. ;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed during screening, at the end of every 8 calendar weeks (±7 days) relative to Study Day 1 up to 24 weeks, then every 12 calendar weeks (±7 days), until confirmed radiographic disease progression by modified RECIST Version 1.1 and/or PCWG3 (for bone lesions only) criteria, loss to FU, withdrawal, or study closure. Tumor assessments will continue to be performed until rad	—

Measure

Time frame

Main Objective: To assess the efficacy of rucaparib versus physician’s choice of treatment based on radiographic progression free survival (rPFS) in metastatic castration-resistant prostate cancer (mCRPC) patients with Homologous Recombination Deficiency (HRD) who progressed on prior AR-directed therapy and have not yet received chemotherapy in the castration-resistant setting.;Secondary Objective: • To assess overall survival (OS) • To assess objective response rate (ORR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in patients with measurable (nodal or visceral) disease • To assess duration of response (DOR) using modified RECIST Version 1.1 in patients with measurable (nodal or visceral) disease • To assess time to PSA progression • To assess PSA response = 50% (all patients) • To assess PSA response = 90% (all patients) • To evaluate Patient-reported Outcome (PRO) using the following instruments: - EuroQol 5 dimensions 5 level questionnaire (EQ-5D-5L) - Functional Assessment of Cancer Therapy–Prostate (FACT-P) - Analgesic drug score - Brief Pain Inventory–Short Form (BPI-SF) instruments • To assess clinical benefit rate (CBR) • To assess sparse pharmacokinetics (PK) • To assess safety and tolerability;Primary end point(s): Efficacy of rucaparib versus physician’s choice of treatment based on radiographic progression free survival (rPFS) in mCRPC patients with HRD who progressed on prior AR-directed therapy and have not yet received chemotherapy in the castration-resistant setting. ;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed during screening, at the end of every 8 calendar weeks (±7 days) relative to Study Day 1 up to 24 weeks, then every 12 calendar weeks (±7 days), until confirmed radiographic disease progression by modified RECIST Version 1.1 and/or PCWG3 (for bone lesions only) criteria, loss to FU, withdrawal, or study closure. Tumor assessments will continue to be performed until rad

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Secondary

Measure	Time frame
Secondary end point(s): • Overall survival (OS) • Objective response rate (ORR) assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in patients with measurable (nodal or visceral) disease • Duration of response (DOR) using modified RECIST Version 1.1 in patients with measurable (nodal or visceral) disease • time to PSA progression • PSA response = 50% (all patients) • PSA response = 90% (all patients) • Patient-reported Outcome (PRO) using the following instruments: - EuroQol 5 dimensions 5 level questionnaire (EQ-5D-5L) - Functional Assessment of Cancer Therapy–Prostate (FACT-P) - Analgesic drug score - Brief Pain Inventory–Short Form (BPI-SF) instruments • clinical benefit rate (CBR) • sparse pharmacokinetics (PK) Safety Analyses Adverse events (AEs), clinical laboratory results, vital signs, ECOG performance status, body weight, and concomitant medications/ procedures will be tabulated and summarized. ;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed during screening, at the end of every 8 calendar weeks (±7 days) relative to Study Day 1 up to 24 weeks, then every 12 calendar weeks (±7 days), until confirmed radiographic disease progression by modified RECIST Version 1.1 and/or PCWG3 (for bone lesions only) criteria, loss to FU, withdrawal, or study closure. Tumor assessments will continue to be performed until radiographic disease progression is confirmed. If a complete response or partial response is noted, confirmatory scans will be performed at least 4 weeks after the initial response was documented. PSA will be measured locally at Screening, Day 1, every 28 days thereafter, and at the Treatment Discontinuation Visit.	—

Measure

Time frame

Secondary end point(s): • Overall survival (OS) • Objective response rate (ORR) assessed using modified Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 in patients with measurable (nodal or visceral) disease • Duration of response (DOR) using modified RECIST Version 1.1 in patients with measurable (nodal or visceral) disease • time to PSA progression • PSA response = 50% (all patients) • PSA response = 90% (all patients) • Patient-reported Outcome (PRO) using the following instruments: - EuroQol 5 dimensions 5 level questionnaire (EQ-5D-5L) - Functional Assessment of Cancer Therapy–Prostate (FACT-P) - Analgesic drug score - Brief Pain Inventory–Short Form (BPI-SF) instruments • clinical benefit rate (CBR) • sparse pharmacokinetics (PK) Safety Analyses Adverse events (AEs), clinical laboratory results, vital signs, ECOG performance status, body weight, and concomitant medications/ procedures will be tabulated and summarized. ;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed during screening, at the end of every 8 calendar weeks (±7 days) relative to Study Day 1 up to 24 weeks, then every 12 calendar weeks (±7 days), until confirmed radiographic disease progression by modified RECIST Version 1.1 and/or PCWG3 (for bone lesions only) criteria, loss to FU, withdrawal, or study closure. Tumor assessments will continue to be performed until radiographic disease progression is confirmed. If a complete response or partial response is noted, confirmatory scans will be performed at least 4 weeks after the initial response was documented. PSA will be measured locally at Screening, Day 1, every 28 days thereafter, and at the Treatment Discontinuation Visit.

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Countries

Australia, Belgium, Canada, Denmark, France, Germany, Ireland, Israel, Italy, Spain, United Kingdom, United States

Contacts

Public ContactHead of Pharmacovigilance

pharmaand GmbH

contact@pharmaand.com+43 1 3560006

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026