Prostate Cancer Clinical Trial

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

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 versus treatment with physician's choice of abiraterone acetate, enzalutamide, or docetaxel.

View Eligibility Criteria

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

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

405

Study ID:

NCT02975934

Recruitment Status:

Active, not recruiting

Sponsor:

pharmaand GmbH

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There are 141 Locations for this study

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University of Alabama at Birmingham
Birmingham Alabama, 35233, United States
Mayo Clinic - Arizona
Phoenix Arizona, 85054, United States
Arizona Oncology Associates - USOR
Tucson Arizona, 85704, United States
University of Southern California
Beverly Hills California, 90210, United States
Alliance Research Centers
Laguna Hills California, 92653, United States
VA Greater Los Angeles Healthcare System
Los Angeles California, 90073, United States
San Bernardino Urological Associates
San Bernardino California, 92404, United States
Sharp Memorial Hospital
San Diego California, 92123, United States
Pacific Hematology Oncology Associates
San Francisco California, 94115, United States
San Francisco VA Health Care System
San Francisco California, 94121, United States
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, United States
St. Joseph Heritage Healthcare
Santa Rosa California, 95403, United States
Kaiser Permanente, Northern CA
Vallejo California, 94589, United States
Rocky Mountain Cancer Centers
Aurora Colorado, 80012, United States
Yale University School of Medicine
New Haven Connecticut, 06510, United States
Medical Oncology Hematology Consultants - USOR
Newark Delaware, 19713, United States
Boca Raton Community Hospital, Inc.
Boca Raton Florida, 33486, United States
University of Florida Health Cancer Center
Orlando Florida, 32806, United States
Atlanta Urological Group
Atlanta Georgia, 30312, United States
Kaiser Permanente Medical Group
Honolulu Hawaii, 96819, United States
Ochsner Medical Center
New Orleans Louisiana, 70121, United States
University of Maryland Greenebaum Cancer Center
Baltimore Maryland, 21201, United States
Walter Reed National Military Medical Center
Bethesda Maryland, 20889, United States
Maryland Oncology Hematology P.A.
Columbia Maryland, 21044, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
VA Ann Arbor Healthcare System
Ann Arbor Michigan, 48105, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Minnesota Oncology Hematology, P.A.
Minneapolis Minnesota, 55404, United States
Minnesota Veterans Research Institute
Minneapolis Minnesota, 55417, United States
University of Minnesota
Minneapolis Minnesota, 55455, United States
Mayo Clinic - Rochester, MN
Rochester Minnesota, 55902, United States
Alegent Health Bergan Mercy Hospital , GU Research Network
Omaha Nebraska, 68130, United States
Nebraska Cancer Specialists
Omaha Nebraska, 68130, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89169, United States
Premier Urology Associates
Lawrenceville New Jersey, 08648, United States
Roswell Park
Buffalo New York, 14263, United States
NYU Perlmutter Cancer Center
New York New York, 10016, United States
Memorial Sloan Kettering CC
New York New York, 10065, United States
Weill Cornell Medical College
New York New York, 10065, United States
Premier Medical Group of the Hudson Valley PC
Poughkeepsie New York, 12601, United States
University of Rochester
Rochester New York, 14642, United States
SUNY Upstate Medical University
Syracuse New York, 13210, United States
University of North Carolina Lineberger Cancer Center
Chapel Hill North Carolina, 27599, United States
Carolina Urology Partners
Concord North Carolina, 28025, United States
Durham VA Medical Center
Durham North Carolina, 27705, United States
Oncology Hematology Care
Cincinnati Ohio, 45211, United States
The Urology Group
Cincinnati Ohio, 45212, United States
Kettering Medical Center
Kettering Ohio, 45429, United States
Clinical Research Solutions
Middleburg Heights Ohio, 44130, United States
VA Portland Health Care System
Portland Oregon, 97219, United States
Northwest Cancer Specialist DBA Compass Oncology
Portland Oregon, 97227, United States
Knight Cancer Institute
Portland Oregon, 97239, United States
Urology Associates Clinical Research
Nashville Tennessee, 37209, United States
Urology Clinics of North Texas
Dallas Texas, 75231, United States
UT Southwestern Medical Center
Dallas Texas, 75390, United States
UT Health Science Center
Houston Texas, 77030, United States
Texas Oncology Cancer Center-Round Rock
Round Rock Texas, 78681, United States
Urology of Virginia
Virginia Beach Virginia, 23462, United States
MultiCare Regional Cancer Center - Gig Harbor
Gig Harbor Washington, 98335, United States
VA Puget Sound HCS
Seattle Washington, 98108, United States
University of Washington Fred Hutchinson Cancer Research Center
Seattle Washington, 98109, United States
Southside Cancer Care Centre
Miranda New South Wales, 2228, Australia
Orange Health Service
Orange New South Wales, 2800, Australia
Northern Cancer Insitute, St. Leonards
Saint Leonards New South Wales, 2065, Australia
St John of God Hospital, Subiaco
Subiaco Western Australia, 6008, Australia
Peninsula & Southeast Oncology
Frankston , 3199, Australia
Barwon Health, University Hospital Geelong
Geelong , 3220, Australia
Royal Hobart Hospital
Hobart , 7000, Australia
Riverina Cancer Care Centre
Wagga Wagga , 2650, Australia
ZNA Middelheim
Antwerp , 2020, Belgium
AZ Groeninge
Kortrijk , 8500, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Clinique et Maternité Sainte-Elisabeth
Namur , 5000, Belgium
Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
Cancer Care Manitoba
Winnipeg Manitoba, R3E 0, Canada
Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
Moncton New Brunswick, E1C 8, Canada
London Health Sciences Centre
London Ontario, N6A 4, Canada
The Ottawa Hospital
Ottawa Ontario, K1H8L, Canada
Princess Margaret Cancer Centre
Toronto Ontario, M5G 2, Canada
Lakeridge Health Medical Specialty Medical Oncology
Oshawa , L1G 2, Canada
Sunnybrook Odette Cancer Centre
Toronto , M4N3M, Canada
Copenhagen University Hospital
Copenhagen , 2100, Denmark
Herlev Hospital
Herlev , 2730, Denmark
Vejle Sygehus
Vejle , 7100, Denmark
Centre Georges François Leclerc
Dijon , 21079, France
Clinique Victor Hugo Centre Jean Bernard
Le Mans , 72000, France
Hôpital Privé La Louvière
Lille , 59000, France
Centre Léon Bérard
Lyon , 69008, France
Polyclinique de Gentilly (Centre D'Oncologie De Gentilly)
Nancy , 54000, France
Institut Curie
Paris , 75248, France
Centre Armoricain de Radiotherapie, Imagerie medicale et Oncologie, CARIO
Plérin , 22190, France
CRLCC Eugene Marquis
Rennes , 35042, France
Institut Gustave-Roussy
Villejuif , 94805, France
Gemeinschaftspraxis für Hämatologie&Onkologie
Augsburg , 86150, Germany
Charite - Universitaetsmedizin Berlin
Berlin , 12200, Germany
Apotheke des Städtischen Klinikums Braunschweig
Braunschweig , 38102, Germany
University Hospital Carl Gustav Carus
Dresden , 01307, Germany
Universitatsklinikum Dusseldorf
Dusseldorf , 40225, Germany
Urologische Gemeinschaftspraxis
Emmendingen , 79312, Germany
Universitaetsklinikum Hamburg-Eppendorf (UKE)
Hamburg , 20246, Germany
Universitatsklinikum Jena
Jena , 07747, Germany
Universitätsklinikum Köln
Köln , 50937, Germany
Universitätsklinikum Schleswig-Holstein
Lubeck , 23538, Germany
Medizinischen Fakultät Mannheim der Universität Heidelberg
Mannheim , 68167, Germany
Studienpraxis Urologie
Nurtingen , 72622, Germany
University of Tuebingen
Tuebingen , 72076, Germany
Die GesundheitsUnion (DGU)
Wuppertal , 42103, Germany
Cork University Hospital
Cork , , Ireland
Adelaide & Meath Hospital, Incorporating the National Children's Hospital
Dublin , , Ireland
Mater Misericordiae University Hospital
Dublin , , Ireland
Mater Private Hospital (MPH)
Dublin , , Ireland
St James's Hospital
Dublin , , Ireland
St. Vincent's University Hospital
Dublin , , Ireland
Rambam Health Care Campus (RHCC), Rambam Medical Center
Haifa , 31096, Israel
Hadassah University Hospital
Jerusalem , 91120, Israel
Meir Medical Center
Kfar Saba , 44281, Israel
Rabin Medical Center-Beilinson Campus
Petach Tikva , 49414, Israel
The Tel Aviv Sourasky Medical Center (Ichilov Hospital)
Tel Aviv , 6423, Israel
Chaim Sheba Medical Center
Tel Hashomer , 52620, Israel
Ospedale San Donato, Azienda USLSUDEST
Arezzo , 52100, Italy
Ospedale Santa Maria delle Croci
Faenza , 48018, Italy
Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica
Meldola , 47014, Italy
IEO Instituto Europeo di Oncologia
Milano , 20141, Italy
University of Modena and Reggio Emilia
Modena , 41124, Italy
Azienda Ospedaliera San Camillo-Forlanini
Roma , 00152, Italy
Azienda Opsedaliera S. Maria di Terni
Terni , 05100, Italy
Presidio Ospedaliero Santa Chiara di Trento
Trento , 38122, Italy
Hospital Universitari Germans Trias i Pujol
Barcelona , 08916, Spain
Hospital Universitario Reina Sofia
Córdoba , 14004, Spain
Hospital General Universitario de Guadalajara
Guadalajara , 19002, Spain
Hospital Universitario Lucus Augusti.
Lugo , 27004, Spain
MD Anderson Cancer Center - Madrid
Madrid , 28033, Spain
Hospital Universitario Ramón y Cajal
Madrid , 28034, Spain
Hospital 12 de Octubre
Madrid , 28041, Spain
Hospital Universitario La Paz
Madrid , 28046, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga , 29010, Spain
Hospital Universitario Central de Asturias
Oviedo , 33011, Spain
Corporacio Sanitaria Parc Tauli
Sabadell , 08208, Spain
Marques de Valdecilla University Hospital (HUMV)
Santander , 39008, Spain
Hospital Universitario Virgen del Rocío
Sevilla , 41013, Spain
Instituto Valenciano de Oncología
Valencia , 46009, Spain
Guy's and St Thomas' NHS Foundation Trust
London England, SE1 9, United Kingdom
Royal Marsden Hospital
London England, SM2 5, United Kingdom
Oxford Cancer Centre, Medical Oncology Unit
Oxford England, OX3 7, United Kingdom
Royal Preston Hospital
Preston England, PR2 9, United Kingdom
Wexham Park Hospital
Slough England, SL2 4, United Kingdom
Velindre Hospital
Cardiff , CF14 , United Kingdom
Royal Marsden Hospital
London , SM2 5, United Kingdom
Musgrove Park Hospital
Taunton , TA15D, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Wirral , CH63 , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

405

Study ID:

NCT02975934

Recruitment Status:

Active, not recruiting

Sponsor:


pharmaand GmbH

How clear is this clinincal trial information?

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