TriangleNCT02975934 · CITED IN SOURCE DOCUMENTS
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- COMPLETED
- Registry last update
- 2025-07-25
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
Overall Survival in Participants With a BRCA Alteration
Overall Survival in Participants With a BRCA or ATM Alteration Combined
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
PSA Response in Participants With a BRCA Alteration
PSA Response in Participants With a BRCA or ATM Alteration Combined
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- 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
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- MALE
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Oral rucaparib (monotherapy).
- intervention Names
- Drug: Rucaparib
- label
- Rucaparib
- type
- EXPERIMENTAL
- description
- Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
- intervention Names
- Drug: Abiraterone acetate or Enzalutamide or Docetaxel
- label
- Abiraterone acetate or Enzalutamide or Docetaxel
- type
- ACTIVE_COMPARATOR
- interventions
- arm Group Labels
- Rucaparib
- description
- Rucaparib will be administered daily.
- name
- Rucaparib
- other Names
- CO-338
- type
- DRUG
- arm Group Labels
- Abiraterone acetate or Enzalutamide or Docetaxel
- description
- Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
- name
- Abiraterone acetate or Enzalutamide or Docetaxel
- other Names
- Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)
- type
- DRUG
Study design
- allocation
- RANDOMIZED
- intervention Model
- PARALLEL
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 405
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
- measure
- Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- description
- The primary efficacy endpoint for the study is rPFSirr, defined as the time from randomization to the first objective evidence of radiographic progression, or death due to any cause (whichever occurs first). Radiographic disease progression includes confirmed soft tissue disease progression and confirmed bone disease progression as per modified RECIST Version 1.1 (at least a 20% increase in the sum of the LD of target lesions or appearance of one or more new extra-skeletal lesions and/or unequivocal progression of existing nontarget lesions) or PCWG3 criteria (Progression by bone is determined by PCWG3 criteria in which at least two new lesions appearing during the first 12-week flare window followed by 2 additional new lesions in the confirmatory scan appearing after the 12-week flare window, or after the 12-week flare window, at least 2 new lesions relative to the first post-treatment scan confirmed on a subsequent scan).
- measure
- Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- secondary Outcomes
- description
- Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participant was last known to be alive.
- measure
- Overall Survival in Participants With a BRCA Alteration
- time Frame
- From enrollment to completion of study (up to approximately 7 years)
- description
- Overall survival time is calculated as the time from randomization to death (by any cause) +1 day. Participants who have not died will be censored on the date the participants was last known to be alive.
- measure
- Overall Survival in Participants With a BRCA or ATM Alteration Combined
- time Frame
- From enrollment to completion of study (up to approximately 7 years)
- description
- ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
- measure
- Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- description
- ORR is defined as the percentage of participants with a confirmed best response of Complete response (CR) or Partial Response (PR) in participants with measurable disease at study entry. Modified RECIST Version 1.1 criteria is used to determine ORR (ie, CR or PR by IRR assessment and no progression in bone per PCWG3 by IRR assessment). CR is disappearance of all target and non-target lesions; any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
- measure
- Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- description
- DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.
- measure
- Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- description
- DOR is defined as the time from the first confirmed response (CR or PR by modified RECIST Version 1.1 in participants with nodal or visceral ± nodal disease) until the first date that Progressive Disease (PD) (using the same criteria) is documented.
- measure
- Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
- time Frame
- From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
- description
- Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.
- measure
- PSA Response in Participants With a BRCA Alteration
- time Frame
- From enrollment to primary completion of study (up to approximately 5 years)
- description
- Confirmed PSA response is defined as ≥ 50% reduction in PSA from baseline on at least two assessments conducted at least 3 weeks apart. PSA response is calculated for all participants with PSA values at baseline and at least one post-baseline assessment. PSA is assessed by a local laboratory.
- measure
- PSA Response in Participants With a BRCA or ATM Alteration Combined
- time Frame
- From enrollment to primary completion of study (up to approximately 5 years)
- description
- Defined as the percentage of participants 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.
- measure
- Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
- time Frame
- From enrollment to 6 months
- description
- Defined as the percentage of participants 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.
- measure
- Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
- time Frame
- From enrollment to 6 months
- description
- Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
- measure
- Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
- time Frame
- From enrollment to primary completion of study (up to approximately 5 years)
- description
- Time to PSA progression is defined as the time from randomization to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline value for participants who did not have a decline in PSA) in PSA was measured. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later.
- measure
- Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
- time Frame
- From enrollment to primary completion of study (up to approximately 5 years)
Full study description
- brief Summary
- 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.
Source references
- references
- citation
- Fizazi K, Piulats JM, Reaume MN, Ostler P, McDermott R, Gingerich JR, Pintus E, Sridhar SS, Bambury RM, Emmenegger U, Lindberg H, Morris D, Nole F, Staffurth J, Redfern C, Saez MI, Abida W, Daugaard G, Heidenreich A, Krieger L, Sautois B, Loehr A, Despain D, Heyes CA, Watkins SP, Chowdhury S, Ryan CJ, Bryce AH; TRITON3 Investigators. Rucaparib or Physician's Choice in Metastatic Prostate Cancer. N Engl J Med. 2023 Feb 23;388(8):719-732. doi: 10.1056/NEJMoa2214676. Epub 2023 Feb 16.
- pmid
- 36795891
- type
- RESULT
- citation
- Collins K, Cheng L. Reprint of: morphologic spectrum of treatment-related changes in prostate tissue and prostate cancer: an updated review. Hum Pathol. 2023 Mar;133:92-101. doi: 10.1016/j.humpath.2023.02.007. Epub 2023 Mar 8.
- pmid
- 36898948
- type
- DERIVED
- citation
- Maia MC, Salgia M, Pal SK. Harnessing cell-free DNA: plasma circulating tumour DNA for liquid biopsy in genitourinary cancers. Nat Rev Urol. 2020 May;17(5):271-291. doi: 10.1038/s41585-020-0297-9. Epub 2020 Mar 17.
- pmid
- 32203306
- type
- DERIVED
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- 14.2 BRCA -mutated Metastatic Castration-Resistant Prostate Cancer TRITON3 The efficacy of RUBRACA was evaluated in TRITON3 ( NCT02975934 ), a randomized, open-label, multi-center trial that evaluated RUBRACA compared to an androgen receptor pathway inhibitor (ARPI; enzalutamide or abiraterone ac
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Preserved source evidence · Not medical advice