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A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3)

Primary Purpose

Metastatic Castration Resistant Prostate Cancer

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rucaparib
Abiraterone acetate or Enzalutamide or Docetaxel
Sponsored by
pharmaand GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer focused on measuring CRPC, PARP inhibitor, PARPi, BRCA, ATM, HRD, TRITON, homologous recombination, DNA repair, DNA defect, DNA anomaly, germline, somatic, mCRPC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic - Arizona
  • Arizona Oncology Associates - USOR
  • University of Southern California
  • Alliance Research Centers
  • VA Greater Los Angeles Healthcare System
  • San Bernardino Urological Associates
  • Sharp Memorial Hospital
  • Pacific Hematology Oncology Associates
  • San Francisco VA Health Care System
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • St. Joseph Heritage Healthcare
  • Kaiser Permanente, Northern CA
  • Rocky Mountain Cancer Centers
  • Yale University School of Medicine
  • Medical Oncology Hematology Consultants - USOR
  • Boca Raton Community Hospital, Inc.
  • University of Florida Health Cancer Center
  • Atlanta Urological Group
  • Kaiser Permanente Medical Group
  • Ochsner Medical Center
  • University of Maryland Greenebaum Cancer Center
  • Walter Reed National Military Medical Center
  • Maryland Oncology Hematology P.A.
  • Massachusetts General Hospital
  • VA Ann Arbor Healthcare System
  • Henry Ford Hospital
  • Minnesota Oncology Hematology, P.A.
  • Minnesota Veterans Research Institute
  • University of Minnesota
  • Mayo Clinic - Rochester, MN
  • Alegent Health Bergan Mercy Hospital , GU Research Network
  • Nebraska Cancer Specialists
  • Comprehensive Cancer Centers of Nevada
  • Premier Urology Associates
  • Roswell Park
  • NYU Perlmutter Cancer Center
  • Memorial Sloan Kettering CC
  • Weill Cornell Medical College
  • Premier Medical Group of the Hudson Valley PC
  • University of Rochester
  • SUNY Upstate Medical University
  • University of North Carolina Lineberger Cancer Center
  • Carolina Urology Partners
  • Durham VA Medical Center
  • Oncology Hematology Care
  • The Urology Group
  • Kettering Medical Center
  • Clinical Research Solutions
  • VA Portland Health Care System
  • Northwest Cancer Specialist DBA Compass Oncology
  • Knight Cancer Institute
  • Urology Associates Clinical Research
  • Urology Clinics of North Texas
  • UT Southwestern Medical Center
  • UT Health Science Center
  • Texas Oncology Cancer Center-Round Rock
  • Urology of Virginia
  • MultiCare Regional Cancer Center - Gig Harbor
  • VA Puget Sound HCS
  • University of Washington Fred Hutchinson Cancer Research Center
  • Southside Cancer Care Centre
  • Orange Health Service
  • Northern Cancer Insitute, St. Leonards
  • St John of God Hospital, Subiaco
  • Peninsula & Southeast Oncology
  • Barwon Health, University Hospital Geelong
  • Royal Hobart Hospital
  • Riverina Cancer Care Centre
  • ZNA Middelheim
  • AZ Groeninge
  • CHU Sart-Tilman
  • Clinique et Maternité Sainte-Elisabeth
  • Tom Baker Cancer Centre
  • Cancer Care Manitoba
  • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
  • London Health Sciences Centre
  • The Ottawa Hospital
  • Princess Margaret Cancer Centre
  • Lakeridge Health Medical Specialty Medical Oncology
  • Sunnybrook Odette Cancer Centre
  • Copenhagen University Hospital
  • Herlev Hospital
  • Vejle Sygehus
  • Centre Georges François Leclerc
  • Clinique Victor Hugo Centre Jean Bernard
  • Hôpital Privé La Louvière
  • Centre Léon Bérard
  • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
  • Institut Curie
  • Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO
  • CRLCC Eugene Marquis
  • Institut Gustave-Roussy
  • Gemeinschaftspraxis für Hämatologie&Onkologie
  • Charite - Universitaetsmedizin Berlin
  • Apotheke des Städtischen Klinikums Braunschweig
  • University Hospital Carl Gustav Carus
  • Universitatsklinikum Dusseldorf
  • Urologische Gemeinschaftspraxis
  • Universitaetsklinikum Hamburg-Eppendorf (UKE)
  • Universitatsklinikum Jena
  • Universitätsklinikum Köln
  • Universitätsklinikum Schleswig-Holstein
  • Medizinischen Fakultät Mannheim der Universität Heidelberg
  • Studienpraxis Urologie
  • University of Tuebingen
  • Die GesundheitsUnion (DGU)
  • Cork University Hospital
  • Adelaide & Meath Hospital, Incorporating the National Children's Hospital
  • Mater Misericordiae University Hospital
  • Mater Private Hospital (MPH)
  • St James's Hospital
  • St. Vincent's University Hospital
  • Rambam Health Care Campus (RHCC), Rambam Medical Center
  • Hadassah University Hospital
  • Meir Medical Center
  • Rabin Medical Center-Beilinson Campus
  • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
  • Chaim Sheba Medical Center
  • Ospedale San Donato, Azienda USLSUDEST
  • Ospedale Santa Maria delle Croci
  • Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
  • IEO Instituto Europeo di Oncologia
  • University of Modena and Reggio Emilia
  • Azienda Ospedaliera San Camillo-Forlanini
  • Azienda Opsedaliera S. Maria di Terni
  • Presidio Ospedaliero Santa Chiara di Trento
  • Hospital Universitari Germans Trias i Pujol
  • Hospital Universitario Reina Sofia
  • Hospital General Universitario de Guadalajara
  • Hospital Universitario Lucus Augusti.
  • MD Anderson Cancer Center - Madrid
  • Hospital Universitario Ramón y Cajal
  • Hospital 12 de Octubre
  • Hospital Universitario La Paz
  • Hospital Clinico Universitario Virgen de la Victoria
  • Hospital Universitario Central de Asturias
  • Corporacio Sanitaria Parc Tauli
  • Marques de Valdecilla University Hospital (HUMV)
  • Hospital Universitario Virgen del Rocío
  • Instituto Valenciano de Oncología
  • Guy's and St Thomas' NHS Foundation Trust
  • Royal Marsden Hospital
  • Oxford Cancer Centre, Medical Oncology Unit
  • Royal Preston Hospital
  • Wexham Park Hospital
  • Velindre Hospital
  • Royal Marsden Hospital
  • Musgrove Park Hospital
  • The Clatterbridge Cancer Centre NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rucaparib

Abiraterone acetate or Enzalutamide or Docetaxel

Arm Description

Oral rucaparib (monotherapy).

Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).

Outcomes

Primary Outcome Measures

Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
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).
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
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).

Secondary Outcome Measures

Interim Overall Survival in Participants With a BRCA Alteration
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.
Interim Overall Survival in Participants With a BRCA or ATM Alteration Combined
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.
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
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.
Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
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.
Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
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.
Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
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.
PSA Response in Participants With a BRCA Alteration
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.
PSA Response in Participants With a BRCA or Alteration Combined
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.
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
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.
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
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.
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
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.
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
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.
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
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.
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
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.
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
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.
Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling
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.

Full Information

First Posted
November 19, 2016
Last Updated
September 14, 2023
Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02975934
Brief Title
A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Acronym
TRITON3
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 13, 2017 (Actual)
Primary Completion Date
August 25, 2022 (Actual)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Castration Resistant Prostate Cancer
Keywords
CRPC, PARP inhibitor, PARPi, BRCA, ATM, HRD, TRITON, homologous recombination, DNA repair, DNA defect, DNA anomaly, germline, somatic, mCRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rucaparib
Arm Type
Experimental
Arm Description
Oral rucaparib (monotherapy).
Arm Title
Abiraterone acetate or Enzalutamide or Docetaxel
Arm Type
Active Comparator
Arm Description
Oral abiraterone acetate (monotherapy, given in combination with prednisone). Oral enzalutamide (monotherapy). Intravenous docetaxel (monotherapy, given in combination with prednisone or prednisolone).
Intervention Type
Drug
Intervention Name(s)
Rucaparib
Other Intervention Name(s)
CO-338
Intervention Description
Rucaparib will be administered daily.
Intervention Type
Drug
Intervention Name(s)
Abiraterone acetate or Enzalutamide or Docetaxel
Other Intervention Name(s)
Zytiga (abiraterone acetate) or Xtandi (enzalutamide) or Taxotere (docetaxel)
Intervention Description
Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
Primary Outcome Measure Information:
Title
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA Alteration
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).
Time Frame
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Title
Radiographic Progression-free Survival (rPFS) by IRR in Participants With a BRCA or ATM Alteration Combined
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).
Time Frame
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Secondary Outcome Measure Information:
Title
Interim Overall Survival in Participants With a BRCA Alteration
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.
Time Frame
From enrollment to primary completion of study (up to approximately 5 years)
Title
Interim Overall Survival in Participants With a BRCA or ATM Alteration Combined
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.
Time Frame
From enrollment to primary completion of study (up to approximately 5 years)
Title
Objective Response Rate (ORR) by IRR in Participants With a BRCA Alteration
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.
Time Frame
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Title
Objective Response Rate (ORR) by IRR in Participants With a BRCA or ATM Alteration Combined
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.
Time Frame
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Title
Duration of Response (DOR) by IRR in Participants With a BRCA Alteration
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.
Time Frame
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Title
Duration of Response (DOR) by IRR in Participants With a BRCA or ATM Alteration Combined
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.
Time Frame
From enrollment to primary completion of study (Total follow-up was up to approximately 4 years)
Title
PSA Response in Participants With a BRCA Alteration
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.
Time Frame
From enrollment to primary completion of study (up to approximately 5 years)
Title
PSA Response in Participants With a BRCA or Alteration Combined
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.
Time Frame
From enrollment to primary completion of study (up to approximately 5 years)
Title
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA Alteration
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.
Time Frame
From enrollment to 6 months
Title
Clinical Benefit Rate (CBR) by IRR at 6 Months in Participants With a BRCA or ATM Alteration Combined
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.
Time Frame
From enrollment to 6 months
Title
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA Alteration
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.
Time Frame
From enrollment to primary completion of study (up to approximately 5 years)
Title
Time to Prostate Specific Antigen (PSA) Progression in Participants With a BRCA or ATM Alteration Combined
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.
Time Frame
From enrollment to primary completion of study (up to approximately 5 years)
Title
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: FACT-P
Description
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.
Time Frame
From enrollment to up to approximately 25 weeks
Title
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: BPI-SF
Description
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.
Time Frame
From enrollment to up to approximately 25 weeks
Title
Change in Patient-reported Outcome (PRO) in Participants With a BRCA Alteration: EQ-5D-5L
Description
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.
Time Frame
From enrollment to up to approximately 25 weeks
Title
Trough Plasma PK (Cmin) of Rucaparib Based on Sparse Sampling
Description
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.
Time Frame
From enrollment to week 5 of dosing

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Mayo Clinic - Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85054
Country
United States
Facility Name
Arizona Oncology Associates - USOR
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
University of Southern California
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Alliance Research Centers
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
VA Greater Los Angeles Healthcare System
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
San Bernardino Urological Associates
City
San Bernardino
State/Province
California
ZIP/Postal Code
92404
Country
United States
Facility Name
Sharp Memorial Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Pacific Hematology Oncology Associates
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
San Francisco VA Health Care System
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
St. Joseph Heritage Healthcare
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Kaiser Permanente, Northern CA
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Medical Oncology Hematology Consultants - USOR
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Boca Raton Community Hospital, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
University of Florida Health Cancer Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Atlanta Urological Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Kaiser Permanente Medical Group
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Ochsner Medical Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
University of Maryland Greenebaum Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889
Country
United States
Facility Name
Maryland Oncology Hematology P.A.
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
VA Ann Arbor Healthcare System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Minnesota Oncology Hematology, P.A.
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Minnesota Veterans Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55417
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic - Rochester, MN
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Alegent Health Bergan Mercy Hospital , GU Research Network
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Nebraska Cancer Specialists
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68130
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89169
Country
United States
Facility Name
Premier Urology Associates
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Roswell Park
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
NYU Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Memorial Sloan Kettering CC
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Premier Medical Group of the Hudson Valley PC
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
SUNY Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
University of North Carolina Lineberger Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolina Urology Partners
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Oncology Hematology Care
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45211
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Clinical Research Solutions
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
VA Portland Health Care System
City
Portland
State/Province
Oregon
ZIP/Postal Code
97219
Country
United States
Facility Name
Northwest Cancer Specialist DBA Compass Oncology
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Urology Associates Clinical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37209
Country
United States
Facility Name
Urology Clinics of North Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
UT Health Science Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology Cancer Center-Round Rock
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Urology of Virginia
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
MultiCare Regional Cancer Center - Gig Harbor
City
Gig Harbor
State/Province
Washington
ZIP/Postal Code
98335
Country
United States
Facility Name
VA Puget Sound HCS
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
University of Washington Fred Hutchinson Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Southside Cancer Care Centre
City
Miranda
State/Province
New South Wales
ZIP/Postal Code
2228
Country
Australia
Facility Name
Orange Health Service
City
Orange
State/Province
New South Wales
ZIP/Postal Code
2800
Country
Australia
Facility Name
Northern Cancer Insitute, St. Leonards
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
St John of God Hospital, Subiaco
City
Subiaco
State/Province
Western Australia
ZIP/Postal Code
6008
Country
Australia
Facility Name
Peninsula & Southeast Oncology
City
Frankston
ZIP/Postal Code
3199
Country
Australia
Facility Name
Barwon Health, University Hospital Geelong
City
Geelong
ZIP/Postal Code
3220
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
ZIP/Postal Code
7000
Country
Australia
Facility Name
Riverina Cancer Care Centre
City
Wagga Wagga
ZIP/Postal Code
2650
Country
Australia
Facility Name
ZNA Middelheim
City
Antwerp
ZIP/Postal Code
2020
Country
Belgium
Facility Name
AZ Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Clinique et Maternité Sainte-Elisabeth
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
Tom Baker Cancer Centre
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
Cancer Care Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
City
Moncton
State/Province
New Brunswick
ZIP/Postal Code
E1C 8X3
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Lakeridge Health Medical Specialty Medical Oncology
City
Oshawa
ZIP/Postal Code
L1G 2B9
Country
Canada
Facility Name
Sunnybrook Odette Cancer Centre
City
Toronto
ZIP/Postal Code
M4N3M5
Country
Canada
Facility Name
Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Herlev Hospital
City
Herlev
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Centre Georges François Leclerc
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
Clinique Victor Hugo Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Hôpital Privé La Louvière
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
City
Nancy
ZIP/Postal Code
54000
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO
City
Plérin
ZIP/Postal Code
22190
Country
France
Facility Name
CRLCC Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Institut Gustave-Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
Gemeinschaftspraxis für Hämatologie&Onkologie
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Apotheke des Städtischen Klinikums Braunschweig
City
Braunschweig
ZIP/Postal Code
38102
Country
Germany
Facility Name
University Hospital Carl Gustav Carus
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitatsklinikum Dusseldorf
City
Dusseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Urologische Gemeinschaftspraxis
City
Emmendingen
ZIP/Postal Code
79312
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf (UKE)
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinikum Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lubeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Medizinischen Fakultät Mannheim der Universität Heidelberg
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Studienpraxis Urologie
City
Nurtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Die GesundheitsUnion (DGU)
City
Wuppertal
ZIP/Postal Code
42103
Country
Germany
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Adelaide & Meath Hospital, Incorporating the National Children's Hospital
City
Dublin
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
Country
Ireland
Facility Name
Mater Private Hospital (MPH)
City
Dublin
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
Country
Ireland
Facility Name
Rambam Health Care Campus (RHCC), Rambam Medical Center
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Rabin Medical Center-Beilinson Campus
City
Petach Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
City
Tel Aviv
ZIP/Postal Code
6423
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
ZIP/Postal Code
5262000
Country
Israel
Facility Name
Ospedale San Donato, Azienda USLSUDEST
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Ospedale Santa Maria delle Croci
City
Faenza
ZIP/Postal Code
48018
Country
Italy
Facility Name
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
City
Meldola
ZIP/Postal Code
47014
Country
Italy
Facility Name
IEO Instituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
University of Modena and Reggio Emilia
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo-Forlanini
City
Roma
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Opsedaliera S. Maria di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Presidio Ospedaliero Santa Chiara di Trento
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital Universitario Reina Sofia
City
Córdoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital General Universitario de Guadalajara
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Hospital Universitario Lucus Augusti.
City
Lugo
ZIP/Postal Code
27004
Country
Spain
Facility Name
MD Anderson Cancer Center - Madrid
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Hospital 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Clinico Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Corporacio Sanitaria Parc Tauli
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Facility Name
Marques de Valdecilla University Hospital (HUMV)
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Instituto Valenciano de Oncología
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Oxford Cancer Centre, Medical Oncology Unit
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Wexham Park Hospital
City
Slough
State/Province
England
ZIP/Postal Code
SL2 4HL
Country
United Kingdom
Facility Name
Velindre Hospital
City
Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
London
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA15DA
Country
United Kingdom
Facility Name
The Clatterbridge Cancer Centre NHS Foundation Trust
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified datasets for study results will be made available to qualified researchers in compliance with applicable privacy laws and data protection regulations. Data will be provided by zr pharma& Austria GmbH
IPD Sharing Time Frame
Data will be made available to qualified researchers after the primary, secondary, and/or exploratory outcomes of the study are reported or published and for 1 year thereafter.
IPD Sharing Access Criteria
Requests for de-identified datasets will be made available to qualified researchers following submission of a methodologically sound proposal to medinfo@pharmaand.com.
Citations:
PubMed Identifier
36795891
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.
Results Reference
result
PubMed Identifier
32203306
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.
Results Reference
derived

Learn more about this trial

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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