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A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2)

Primary Purpose

Metastatic Castration Resistant Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rucaparib
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, BARD1, BRIP1, CDK12, CHEK2, FANCA, NBN, PALB2, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, 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 form is signed
  • Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate
  • Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM)
  • Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease
  • Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency

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, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy
  • 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 rucaparib

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinc
  • Arizona Oncology Associates
  • Alliance Research Centers
  • VA Greater Los Angeles Healthcare System
  • University of Southern California
  • Stanford University
  • Sharp Memorial Hospital
  • Pacific Hematology Oncology Associates
  • San Francisco VA Health Care System
  • UCSF Helen Diller Family Comprehensive Cancer Center
  • Redwood Regional Medical Group
  • Kaiser Permanente Medical Center (Vallejo)
  • Rocky Mountain Cancer Centers
  • Yale School of Medicine
  • 4701 Ogletown Stanton Rd.
  • Georgetown University Medical Center
  • Boca Raton Community Hospital, Inc.
  • Florida Cancer Specialists
  • University of Florida Health Cancer Center
  • Moffitt Cancer Center
  • Atlanta Urological Group
  • University of Chicago Comprehensive Cancer Center
  • Ochsner Medical Center
  • University of Maryland Greenebaum Cancer Center
  • Walter Reed Hospital
  • Massachusetts General Hospital
  • VA Ann Arbor Healthcare System
  • Henry Ford Hospital
  • Fairview Hospital
  • Minnesota Oncology Hematology, P.A.
  • Minnesota Veterans Research Institute
  • HCA Midwest Division - Kansas City
  • Alegent Health Bergan Mercy Hospital , GU Research Network
  • Nebraska Cancer Specialists
  • Comprehensive Cancer Centers of Nevada
  • Premier Urology Associates dba/AdvanceMed Research
  • Rutgers Cancer Institute of New Jersey
  • Roswell Park
  • NYU Perlmutter Cancer Center
  • Memorial Sloan Kettering CC
  • Weill Cornell Medical College/NewYork-Presbyterian Hospital
  • Premier Medical Group of the Hudson Valley PC
  • University of Rochester
  • SUNY Upstate Medical University
  • Carolina Urology Partners
  • The Urology Group
  • Kettering Cancer Center
  • Clinical Research Solutions
  • VA Portland Health Care System
  • Consultants in Medical Oncology Hematology
  • SCRI - Tennessee Oncology
  • Texas Oncology Medical City Dallas
  • UT Southwestern Medical Center
  • UT Health Science Center
  • Texas Oncology - Tyler
  • Virginia Oncology Associates
  • VA Puget Sound
  • Northern Cancer Insitute, St. Leonards
  • Royal Hobart Hospital
  • Peninsula & Southeast Oncology
  • Barwon Health, University Hospital Geelong
  • Cabrini Hospital
  • Southside Cancer Care Centre
  • Orange Health Services
  • St John of God Hospital, Subiaco
  • Riverina Cancer Care Centre
  • ZNA Middelheim
  • Universitair Ziekenhuis Gent
  • AZ Groeninge
  • CHU Sart-Tilman
  • Equipe de Recherche Clinique, Département d'Oncologie/Hématologie
  • AZ DELTA
  • Juravinski Cancer Centre Hamilton Health Services
  • London Health Science Center - Victoria Hospital
  • The Ottawa Hospital
  • Princess Margaret Hospital
  • Copenhagen University Hospital
  • Herlev Hospital
  • Vejle Sygehus
  • Centre François Baclesse
  • Centre Georges François Leclerc
  • Clinique Victor Hugo Centre Jean Bernard
  • Hôpital Privé La Louvière
  • Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
  • Institut Curie
  • Hôpital Privé des Côtes d'Armor
  • CRLCC Eugene Marquis
  • Gemeinschaftspraxis fur Hamatologie & Onkologie
  • Charite Universitatsmedizin Berlin
  • Universitatsklinikum Carl Gustav Carus
  • Universitatsklinikum Dusseldorf
  • Urologische Gemeinschaftspraxis
  • Universitaetsklinikum Hamburg-Eppendorf (UKE)
  • Universitaetsklinikum Heidelberg
  • Universitatsklinikum Jena
  • Universitätsklinik Köln
  • Universitätsklinikum Schleswig-Holstein
  • Medizinischen Fakultät Mannheim der Universität Heidelberg
  • Studienpraxis Urologie
  • University of Tuebingen
  • Die Gesundhehitsunion DGU
  • Cork University Hospital
  • St. Vincent's University Hospital
  • St James's Hospital
  • Adelaide & Meath Hospital, Incorporating the National Children's Hospital
  • Mater Misericordiae University Hospital
  • Rambam Health Care Campus (RHCC), Rambam Medical Center
  • Hadassah University Hospital
  • Meir Medical Center
  • Rabin Medical Center-Beilinson Campus
  • Chaim Sheba Medical Center
  • The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
  • Ospedale San Donato, Azienda USLSUDEST
  • Ospedale Santa Maria delle Croci
  • IRCCS Istituto Nazionale dei Tumori (INT)
  • IEO Instituto Europeo di Oncologia
  • University of Modena and Reggio Emilia Medical Oncology
  • Azienda Ospedaliera San Camillo-Forlanini
  • Azienda Opsedaliera S. Maria di Terni
  • Santa Chiara Hospital, Dept Medical Oncology
  • Hospital Universitari Germans Trias i Pujol
  • Hospital del Mar, Servicio de Oncología
  • Hospital Clínic i Provincial de Barcelona-Oncology
  • Instituto Catalan de Oncologia
  • Hospital Universitari Germans Trias i Pujol
  • 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 Puerta de Hierro-Majadahonda
  • Hospital Universitario Central de Asturias
  • Corporacio Sanitaria Parc Tauli
  • Marques de Valdecilla University Hospital (HUMV)
  • Hospital Universitario Virgen del Rocío
  • Instituto Valenciano de Oncologia IVO
  • Wexham Park Hospital
  • Mount Vernon Cancer Centre
  • Royal Marsden Hospital
  • Oxford University Hospitals
  • Royal Liverpool Hospital
  • London Health Science Center - Victoria Hospital
  • Guy's Hospital
  • Sarah Cannon Research Institutute - UK
  • Southampton General Hospital
  • Musgrove Park Hospital
  • The Clatterbridge Cancer Centre NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rucaparib

Arm Description

Oral rucaparib (monotherapy)

Outcomes

Primary Outcome Measures

Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)
The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. 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 diameters.

Secondary Outcome Measures

Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)
A supportive efficacy endpoint is confirmed radiographic ORR by INV. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. 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 Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)
A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator
A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory
A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.
Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory
A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)
A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator
A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.
Overall Survival (OS) by Gene
A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.
Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)
A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
Clinical Benefit Rate (CBR) by Gene Per Investigator
A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
Time to PSA Progression by Gene
A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.
Steady State Trough (Cmin) Level Rucaparib Concentrations
Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.

Full Information

First Posted
October 24, 2016
Last Updated
June 7, 2023
Sponsor
pharmaand GmbH
Collaborators
Foundation Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02952534
Brief Title
A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
Acronym
TRITON2
Official Title
TRITON2: A Multicenter, Open-label Phase 2 Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer Associated With Homologous Recombination Deficiency
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
July 18, 2021 (Actual)
Study Completion Date
July 27, 2021 (Actual)

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 patients with metastatic castration-resistant prostate cancer, and evidence of a homologous recombination gene deficiency, respond to treatment with rucaparib.

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, BARD1, BRIP1, CDK12, CHEK2, FANCA, NBN, PALB2, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, germline, somatic, mCRPC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
277 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rucaparib
Arm Type
Experimental
Arm Description
Oral rucaparib (monotherapy)
Intervention Type
Drug
Intervention Name(s)
Rucaparib
Other Intervention Name(s)
CO-338
Intervention Description
Rucaparib will be administered daily
Primary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Central Independent Radiology Review (IRR)
Description
The primary efficacy endpoint is confirmed radiographic ORR by central IRR. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. 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 diameters.
Time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Secondary Outcome Measure Information:
Title
Confirmed Objective Response Rate (ORR) by Gene in Patients With Measurable Disease at Baseline Per Investigator (INV)
Description
A supportive efficacy endpoint is confirmed radiographic ORR by INV. ORR is defined as the percentage of patients with a confirmed CR (complete response) or PR (partial response) by mRECIST (modified Response Evaluation Criteria in Solid Tumors) v1.1/PCWG3 (Prostate Cancer Working Group 3) criteria. The confirmed response is defined as a CR or PR on subsequent tumor assessment at least 28 days after first response documentation in the absence of confirmed progression in bone. 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
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Title
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Central Independent Radiology Review (IRR)
Description
A secondary efficacy endpoint is DOR by central IRR. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
Time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Title
Duration of Response (DOR) by Gene in Patients With Confirmed Response Per Investigator
Description
A secondary efficacy endpoint is DOR as assessed by the investigator. The DOR is defined as the time from the date that a confirmed response per modified RECIST Version 1.1/PCWG3 is first reported to the time that progressive disease (PD) is first documented. Progressive disease is defined using RECIST v1.1, as at least a 20% increase in the sum of the diameters of target lesions, or an unequivocal increase in non-target lesions, or the appearance of new lesions. PCWG3 criteria is used to document evidence of disease progression in bone lesions.
Time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Title
Confirmed PSA Response (≥ 50% Decrease) by Gene as Assessed by Local Laboratory
Description
A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 50% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 50% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.
Time Frame
PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
Title
Confirmed PSA Response (≥ 90% Decrease) by Gene as Assessed by Local Laboratory
Description
A secondary endpoint is confirmed PSA (prostate-specific antigen) response (≥ 90% reduction) as assessed by local laboratory. Confirmed PSA response is analyzed for all patients who had PSA value at baseline and is defined as the percentage of patients having 2 consecutive PSA values (at least 3 weeks apart) that are at least 90% lower than baseline and that occur prior to PSA progression. PSA progression is defined as a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir in PSA.
Time Frame
PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
Title
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Central Independent Radiology Review (IRR)
Description
A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by IRR. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression adjudicated by IRR using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.
Time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Title
Radiologic Progression-free Survival (rPFS) by Gene in All Patients Per Investigator
Description
A secondary efficacy endpoint is Radiologic Progression-free Survival (rPFS) assessed by Investigator. rPFS is defined as the time from first dose of rucaparib to the date of first objective evidence of radiographic progression (soft tissue or bone lesion) or death due to any cause, whichever occurs first, plus 1 day. Radiographic disease progression includes confirmed bone disease progression and soft tissue disease progression using the PCWG3 guidelines for bone disease and modified RECIST Version 1.1 for soft tissue disease.
Time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Title
Overall Survival (OS) by Gene
Description
A secondary efficacy endpoint is Overall Survival (OS). OS is defined as the date from first dose of rucaparib to the date of death due to any cause, +1 day.
Time Frame
From date of first dose until event, loss to follow-up, withdrawal of consent, or study closure: an overall median of approximately 33.1 months
Title
Clinical Benefit Rate (CBR) by Gene Per Central Independent Radiology Review (IRR)
Description
A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by IRR. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
Time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Title
Clinical Benefit Rate (CBR) by Gene Per Investigator
Description
A secondary efficacy endpoint is Clinical Benefit Rate (CBR) assessed by Investigator. CBR is defined as the number of patients without radiographic progression (defined by modified RECIST Version 1.1/ PCWG3 criteria) who were continuing with study drug treatment through the given time interval divided by the number of patients who had the given amount of follow-up. Clinical benefit rates are summarized at 6 and 12 months.
Time Frame
Assessments every 8 weeks from study day 1 for the first 24 weeks, and then every 12 weeks until disease progression, death, or initiation of subsequent treatment. Total follow-up was up to approximately 3 years.
Title
Time to PSA Progression by Gene
Description
A secondary efficacy endpoint is time to PSA progession. Time to PSA progression is defined as the time from first dose of rucaparib to the date that a ≥ 25% increase and absolute increase of ≥ 2 ng/mL above the nadir (or baseline if there was no PSA decline after baseline) in PSA was measured, plus 1 day. The increase must be confirmed by a second consecutive assessment conducted at least 3 weeks later (unless the PSA progression occurred at the last recorded PSA assessment). If confirmed, the date used for time of PSA progression is the earlier of the 2 PSA dates.
Time Frame
PSA assessments were done at baseline, Week 5, Week 9, every 4 weeks thereafter, and at Treatment Discontinuation. Total follow-up was up to approximately 39 months.
Title
Steady State Trough (Cmin) Level Rucaparib Concentrations
Description
Trough (Cmin) concentrations of rucaparib are summarized for all patients with at least one PK sample collected. The absolute values of rucaparib plasma concentration at each time point are presented by gene.
Time Frame
Participants were assessed at Study Day 29, Day 57, Day 85 and Day 113

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 form is signed Have a histologically or cytologically confirmed adenocarcinoma or poorly differentiated carcinoma of the prostate Be surgically or medically castrated, with serum testosterone levels of ≤ 50 ng/dL (1.73 nM) Experienced disease progression after having received at least 1 but no more than 2 prior next-generation androgen receptor-targeted therapies, and 1 prior taxane-based chemotherapy, for castration-resistant disease Have a deleterious mutation in BRCA1/2 or ATM, or molecular evidence of other homologous recombination deficiency 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, mitoxantrone, cyclophosphamide or any platinum-based chemotherapy 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 rucaparib
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
Arizona Oncology Associates
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
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
University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
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
94143
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
Redwood Regional Medical Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95406
Country
United States
Facility Name
Kaiser Permanente Medical Center (Vallejo)
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 School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
4701 Ogletown Stanton Rd.
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
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
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33980
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
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Atlanta Urological Group
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
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 Hospital
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
48202
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
Fairview Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
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
HCA Midwest Division - Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
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
89119
Country
United States
Facility Name
Premier Urology Associates dba/AdvanceMed Research
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
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/NewYork-Presbyterian Hospital
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
12301
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
Carolina Urology Partners
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
The Urology Group
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Kettering Cancer 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
Consultants in Medical Oncology Hematology
City
Horsham
State/Province
Pennsylvania
ZIP/Postal Code
19044
Country
United States
Facility Name
SCRI - Tennessee Oncology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Oncology Medical City Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75320
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 - Tyler
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
VA Puget Sound
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States
Facility Name
Northern Cancer Insitute, St. Leonards
City
Saint Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Royal Hobart Hospital
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
Facility Name
Peninsula & Southeast Oncology
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Barwon Health, University Hospital Geelong
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Southside Cancer Care Centre
City
Miranda
ZIP/Postal Code
2228
Country
Australia
Facility Name
Orange Health Services
City
Orange
ZIP/Postal Code
2800
Country
Australia
Facility Name
St John of God Hospital, Subiaco
City
Subiaco
ZIP/Postal Code
6008
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
Universitair Ziekenhuis Gent
City
Gent
ZIP/Postal Code
B-9000
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
Equipe de Recherche Clinique, Département d'Oncologie/Hématologie
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
AZ DELTA
City
Roeselare
ZIP/Postal Code
B-8800
Country
Belgium
Facility Name
Juravinski Cancer Centre Hamilton Health Services
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V5C2
Country
Canada
Facility Name
London Health Science Center - Victoria Hospital
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 Hospital
City
Toronto
ZIP/Postal Code
M5G 2M9
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 François Baclesse
City
Caen
ZIP/Postal Code
14000
Country
France
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
59800
Country
France
Facility Name
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
City
Nancy
ZIP/Postal Code
54100
Country
France
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Facility Name
Hôpital Privé des Côtes d'Armor
City
Plérin
ZIP/Postal Code
22190
Country
France
Facility Name
CRLCC Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Gemeinschaftspraxis fur Hamatologie & Onkologie
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Charite Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
12200
Country
Germany
Facility Name
Universitatsklinikum 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
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitätsklinik Köln
City
Köln
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein
City
Lübeck
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
Nürtingen
ZIP/Postal Code
72622
Country
Germany
Facility Name
University of Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Die Gesundhehitsunion DGU
City
Wuppertal
ZIP/Postal Code
42103
Country
Germany
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12 DFK4
Country
Ireland
Facility Name
St. Vincent's University Hospital
City
Dublin
ZIP/Postal Code
D04T6F4
Country
Ireland
Facility Name
St James's Hospital
City
Dublin
ZIP/Postal Code
D08 NHY1
Country
Ireland
Facility Name
Adelaide & Meath Hospital, Incorporating the National Children's Hospital
City
Dublin
ZIP/Postal Code
Dublin 24
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
Dublin 7
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
71120
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
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
City
Tel Aviv
ZIP/Postal Code
64231
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
IRCCS Istituto Nazionale dei Tumori (INT)
City
Milano
ZIP/Postal Code
20133
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 Medical Oncology
City
Modena
ZIP/Postal Code
41124
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo-Forlanini
City
Rome
ZIP/Postal Code
00152
Country
Italy
Facility Name
Azienda Opsedaliera S. Maria di Terni
City
Terni
ZIP/Postal Code
05100
Country
Italy
Facility Name
Santa Chiara Hospital, Dept Medical Oncology
City
Trento
ZIP/Postal Code
38122
Country
Italy
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital del Mar, Servicio de Oncología
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Clínic i Provincial de Barcelona-Oncology
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Instituto Catalan de Oncologia
City
Barcelona
ZIP/Postal Code
08908
Country
Spain
Facility Name
Hospital Universitari Germans Trias i Pujol
City
Barcelona
ZIP/Postal Code
08916
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
27003
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 Puerta de Hierro-Majadahonda
City
Madrid
ZIP/Postal Code
28222
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
8208
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 Oncologia IVO
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
Wexham Park Hospital
City
Slough
State/Province
Berkshire
ZIP/Postal Code
SL2 4HL
Country
United Kingdom
Facility Name
Mount Vernon Cancer Centre
City
Northwood
State/Province
England
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Oxford University Hospitals
City
Headington
ZIP/Postal Code
OC3 7LJ
Country
United Kingdom
Facility Name
Royal Liverpool Hospital
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
London Health Science Center - Victoria Hospital
City
London
ZIP/Postal Code
N6A 4L6
Country
United Kingdom
Facility Name
Guy's Hospital
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
Sarah Cannon Research Institutute - UK
City
London
ZIP/Postal Code
W1G 6AD
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Musgrove Park Hospital
City
Taunton
ZIP/Postal Code
TA1 5DA
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 Clovis Oncology.
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@clovisoncology.com.
Citations:
PubMed Identifier
35397664
Citation
Green ML, Ma SC, Goble S, Giordano H, Maloney L, Simmons AD, Beltman J, Harding TC, Xiao JJ. Population pharmacokinetics of rucaparib in patients with advanced ovarian cancer or other solid tumors. Cancer Chemother Pharmacol. 2022 May;89(5):671-682. doi: 10.1007/s00280-022-04413-7. Epub 2022 Apr 10.
Results Reference
derived
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 in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency

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