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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT02975934
Registration number
NCT02975934
Ethics application status
Date submitted
19/11/2016
Date registered
29/11/2016
Date last updated
20/03/2024
Titles & IDs
Public title
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
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Scientific 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
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Secondary ID [1]
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CO-338-063
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Universal Trial Number (UTN)
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Trial acronym
TRITON3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Metastatic Castration Resistant Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Rucaparib
Treatment: Drugs - Abiraterone acetate or Enzalutamide or Docetaxel
Experimental: Rucaparib - Oral rucaparib (monotherapy).
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).
Treatment: Drugs: Rucaparib
Rucaparib will be administered daily.
Treatment: Drugs: Abiraterone acetate or Enzalutamide or Docetaxel
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
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Assessment method [1]
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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).
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Timepoint [1]
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From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
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Primary outcome [2]
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Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
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Assessment method [2]
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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).
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Timepoint [2]
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From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
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Secondary outcome [1]
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Interim Overall Survival in Participants With a BRCA Alteration
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Assessment method [1]
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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.
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Timepoint [1]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [2]
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Interim Overall Survival in Participants With a BRCA or ATM Alteration Combined
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Assessment method [2]
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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.
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Timepoint [2]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [3]
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Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
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Assessment method [3]
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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.
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Timepoint [3]
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From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
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Secondary outcome [4]
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Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
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Assessment method [4]
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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.
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Timepoint [4]
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From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
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Secondary outcome [5]
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Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
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Assessment method [5]
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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.
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Timepoint [5]
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From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
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Secondary outcome [6]
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Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
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Assessment method [6]
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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.
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Timepoint [6]
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From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
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Secondary outcome [7]
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PSA Response in Participants With a BRCA Alteration
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Assessment method [7]
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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.
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Timepoint [7]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [8]
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PSA Response in Participants With a BRCA or ATM Alteration Combined
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Assessment method [8]
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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.
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Timepoint [8]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [9]
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Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
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Assessment method [9]
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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.
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Timepoint [9]
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From enrollment to 6 months
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Secondary outcome [10]
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Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
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Assessment method [10]
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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.
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Timepoint [10]
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From enrollment to 6 months
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Secondary outcome [11]
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Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
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Assessment method [11]
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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.
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Timepoint [11]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [12]
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Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
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Assessment method [12]
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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.
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Timepoint [12]
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From enrollment to primary completion of study (up to approximately 5 years)
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Secondary outcome [13]
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Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
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Assessment method [13]
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Changes in health and pain status from baseline to week 25 using: Functional Assessment of Cancer Therapy-Prostate questionnaire (FACT-P total score, on a scale of 0 to 156 where a higher score is better quality of life). The greater the decrease in score (ie more negative) from baseline to week 25 the greater the decrease in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
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Timepoint [13]
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From enrollment to up to approximately 25 weeks
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Secondary outcome [14]
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Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
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Assessment method [14]
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Changes in health and pain status from baseline to week 25 using: Brief Pain Inventory-Short Form (BPI-SF) questionnaire (on a scale of 1 to 10, from mild to severe, for pain and pain-interference scores). A decrease indicates less severe pain/interference. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) (during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
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Timepoint [14]
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From enrollment to up to approximately 25 weeks
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Secondary outcome [15]
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Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
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Assessment method [15]
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Changes in health and pain status from baseline to week 25 using: EuroQol-5D-5L Visual Analogue Scale (EQ-5D-5L VAS; on a scale from 100 to 0, from best to worst health status). The greater the increase in score (including more negative) from baseline to week 25 the greater the increase in health status. Assessments completed during screening, at study treatment visits (Day 1, Day 15, Day 29, Day 43, Day 57, and every 29 days thereafter) during the Treatment Phase, the Treatment Discontinuation Visit, and during the Follow-up Phase.
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Timepoint [15]
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From enrollment to up to approximately 25 weeks
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Secondary outcome [16]
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Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling
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Assessment method [16]
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Mean trough PK plasma concentration over time in the safety population with at least one PK sample collected at timepoints week 5, 9, 13 and 17; only Week 5 data presented.
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Timepoint [16]
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From enrollment to week 5 of dosing
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/06/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/12/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
405
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Southside Cancer Care Centre - Miranda
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Recruitment hospital [2]
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Orange Health Service - Orange
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Recruitment hospital [3]
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Northern Cancer Insitute, St. Leonards - Saint Leonards
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Recruitment hospital [4]
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St John of God Hospital, Subiaco - Subiaco
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Recruitment hospital [5]
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Peninsula & Southeast Oncology - Frankston
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Recruitment hospital [6]
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Barwon Health, University Hospital Geelong - Geelong
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Recruitment hospital [7]
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Royal Hobart Hospital - Hobart
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Recruitment hospital [8]
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Riverina Cancer Care Centre - Wagga Wagga
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Recruitment postcode(s) [1]
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2228 - Miranda
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Recruitment postcode(s) [2]
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2800 - Orange
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Recruitment postcode(s) [3]
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2065 - Saint Leonards
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Recruitment postcode(s) [4]
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6008 - Subiaco
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Recruitment postcode(s) [5]
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3199 - Frankston
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Recruitment postcode(s) [6]
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3220 - Geelong
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Recruitment postcode(s) [7]
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7000 - Hobart
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Recruitment postcode(s) [8]
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2650 - Wagga Wagga
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Recruitment outside Australia
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Tel Aviv
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Israel
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Tel Hashomer
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Italy
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Arezzo
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Italy
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Faenza
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Italy
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Meldola
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Italy
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Milano
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Italy
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Modena
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Italy
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Roma
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Italy
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Terni
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Italy
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Trento
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Spain
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Barcelona
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Country [79]
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Spain
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Córdoba
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Country [80]
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Spain
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Guadalajara
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Spain
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Lugo
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Oviedo
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Spain
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Sabadell
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Spain
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Santander
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Country [87]
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Spain
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Sevilla
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Country [88]
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Spain
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Valencia
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Country [89]
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United Kingdom
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England
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United Kingdom
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Cardiff
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United Kingdom
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London
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United Kingdom
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Taunton
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United Kingdom
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State/province [93]
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Wirral
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
pharmaand GmbH
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Commercial sector/Industry
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Foundation Medicine
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Ethics approval
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT02975934
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Contacts
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT02975934
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