Prostate Cancer Clinical Trial
Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
Summary
The purpose of this study is to evaluate the efficacy and safety of olaparib versus enzalutamide or abiraterone acetate in subjects with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have homologous recombination repair gene mutations.
Full Description
This is a prospective, multicenter, randomized, open-label, phase 3 trial evaluating the efficacy and safety of olaparib versus enzalutamide or abiraterone in subjects with metastatic castration-resistant prostate cancer (mCRPC) who have failed prior treatment with a new hormonal agent (NHA) and have a qualifying tumor mutation in one of 15 genes involved in the homologous recombination repair (HRR) pathway. Subjects will be divided into two cohorts based on HRR gene mutation status.
Approximately 340 subjects will be randomized 2:1 (olaparib : investigator choice of enzalutamide or abiraterone acetate) into the trial.
Eligibility Criteria
Inclusion criteria
Histologically confirmed diagnosis of prostate cancer.
Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
Subjects must have progressed on prior new hormonal agent (e.g. abiraterone acetate and/or enzalutamide) for the treatment of metastatic prostate cancer and/or CRPC .
Ongoing therapy with LHRH analog or bilateral orchiectomy.
Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
Qualifying HRR mutation in tumor tissue.
Exclusion criteria
Any previous treatment with PARP inhibitor, including olaparib.
Subjects who have any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose > 5 years prior to randomization.
Other malignancy (including MDS and MGUS) within the last 5 years except: adequately treated non-melanoma skin cancer or other solid tumors curatively treated with no evidence of disease for ≥5 years.
Subjects with known brain metastases.
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There are 201 Locations for this study
Anchorage Alaska, 99503, United States
Tucson Arizona, 85704, United States
Tucson Arizona, 85741, United States
Duarte California, 91010, United States
San Diego California, 92161, United States
Santa Barbara California, 93105, United States
Washington District of Columbia, 20007, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30318, United States
Chicago Illinois, 60611, United States
Jeffersonville Indiana, 47130, United States
New Orleans Louisiana, 70112, United States
Baltimore Maryland, 21287, United States
Towson Maryland, 21204, United States
Omaha Nebraska, 68130, United States
Las Vegas Nevada, 89135, United States
Albany New York, 12208, United States
Bronx New York, 10468, United States
Brooklyn New York, 11201, United States
Syracuse New York, 13210, United States
Durham North Carolina, 27710, United States
Salisbury North Carolina, 28144, United States
Columbus Ohio, 43230, United States
Oklahoma City Oklahoma, 73104, United States
Springfield Oregon, 97477, United States
Tualatin Oregon, 97062, United States
Charleston South Carolina, 29401, United States
Myrtle Beach South Carolina, 29572, United States
Germantown Tennessee, 38138, United States
Nashville Tennessee, 37232, United States
San Antonio Texas, 78229, United States
Salt Lake City Utah, 84112, United States
Salt Lake City Utah, 84148, United States
Spokane Washington, 99202, United States
Wheeling West Virginia, 26003, United States
Buenos Aires , 1426, Argentina
Buenos Aires , C1118, Argentina
Buenos Aires , C1120, Argentina
Caba , C1280, Argentina
La Rioja , 5300, Argentina
Rosario , 2000, Argentina
Adelaide , 5000, Australia
Box Hill , 3128, Australia
Clayton , 3168, Australia
Greenslopes , 4120, Australia
Herston , 4029, Australia
Macquarie University , 2109, Australia
Melbourne , 3000, Australia
Nedlands , 6009, Australia
Randwick , 2031, Australia
Waratah , 2298, Australia
Graz , 8036, Austria
Linz , 4020, Austria
Salzburg , 5020, Austria
Wien , 1020, Austria
Wien , 1090, Austria
Barretos , 14784, Brazil
Belo Horizonte , 30110, Brazil
Curitiba , 80530, Brazil
Florianópolis , 88034, Brazil
Passo Fundo , 99010, Brazil
Porto Alegre , 90160, Brazil
Porto Alegre , 90610, Brazil
Recife , 50040, Brazil
Ribeirao Preto , 14015, Brazil
Rio de Janeiro , 22793, Brazil
Santo Andre , 09060, Brazil
São José do Rio Preto , 15090, Brazil
São Paulo , 01321, Brazil
São Paulo , 03102, Brazil
Edmonton Alberta, T6G 1, Canada
Kelowna British Columbia, V1Y 5, Canada
Vancouver British Columbia, V5Z 4, Canada
Hamilton Ontario, L8V 5, Canada
Oakville Ontario, L6H 3, Canada
Toronto Ontario, M4N 3, Canada
Toronto Ontario, M5G 2, Canada
Chicoutimi Quebec, G7H 5, Canada
Montreal Quebec, H2X 3, Canada
Montreal Quebec, H4A 3, Canada
Saskatoon Saskatchewan, S7N 4, Canada
Quebec , G1J 1, Canada
Odense C , 5000, Denmark
BESANCON Cedex , 25030, France
Bordeaux Cedex , 33000, France
Caen , 14000, France
Lille , 59020, France
Lyon Cedex 08 , 69008, France
Marseille cedex 09 , 13273, France
Montpellier , 34298, France
Paris , 75014, France
Poitiers Cedex , 86021, France
Saint Herblain , 44805, France
Toulouse Cedex 09 , 31100, France
Vandoeuvre les Nancy , 54519, France
Villejuif , 94805, France
Bergisch Gladbach , 51465, Germany
Berlin , 13055, Germany
Bremen , 28277, Germany
Duisburg , 47179, Germany
Düsseldorf , 40225, Germany
Hamburg , 22399, Germany
Heidelberg , 69120, Germany
Holzminden , 37603, Germany
Jena , 07747, Germany
Köln , 50968, Germany
Magdeburg , 39120, Germany
Nürnberg , 90491, Germany
Nürtingen , 72622, Germany
Tübingen , 72076, Germany
Wuppertal , 42109, Germany
Haifa , 31096, Israel
Jerusalem , 91120, Israel
Kfar Saba , 95847, Israel
Petach-Tikva , 49414, Israel
Ramat Gan , 52656, Israel
Zerifin , 70300, Israel
Ancona , 60126, Italy
Arezzo , 52100, Italy
Bari , 70124, Italy
Brescia , 25100, Italy
Meldola , 47014, Italy
Milano , 20133, Italy
Milano , 20141, Italy
Modena , 41124, Italy
Napoli , 80131, Italy
Trento , 38100, Italy
Bunkyo-ku , 113-8, Japan
Bunkyo-ku , 113-8, Japan
Bunkyo-ku , 113-8, Japan
Fukuoka , 812-8, Japan
Hirosaki-shi , 036-8, Japan
Kanazawa-shi , 920-8, Japan
Kashihara-shi , 634-8, Japan
Kashiwa , 277-8, Japan
Kawagoe-shi , 350-8, Japan
Kita-gun , 761-0, Japan
Koto-ku , 135-8, Japan
Kyoto-shi , 606-8, Japan
Maebashi-shi , 371-8, Japan
Matsuyama-shi , 791-0, Japan
Minato-ku , 105-8, Japan
Mitaka-shi , 181-8, Japan
Miyazaki-shi , 889-1, Japan
Nagasaki-shi , 852-8, Japan
Nagoya-shi , 464-8, Japan
Nagoya-shi , 466-8, Japan
Osaka-shi , 541-8, Japan
Osaka-shi , 545-8, Japan
Osakasayama-shi , 589-8, Japan
Sagamihara-shi , 252-0, Japan
Sakura-shi , 285-8, Japan
Sapporo-shi , 060-8, Japan
Shinjuku-ku , 160-8, Japan
Suita-shi , 565-0, Japan
Sunto-gun , 411-8, Japan
Yokohama-shi , 232-0, Japan
Busan , 49241, Korea, Republic of
Daegu , 41404, Korea, Republic of
Goyang-si , 10408, Korea, Republic of
Gwangju , 61469, Korea, Republic of
Seoul , 03722, Korea, Republic of
Seoul , 05505, Korea, Republic of
Seoul , 06273, Korea, Republic of
Seoul , 06351, Korea, Republic of
Seoul , 06591, Korea, Republic of
Amsterdam , 1066 , Netherlands
Hilversum , 1213 , Netherlands
Leiden , 2333 , Netherlands
Nijmegen , 6525 , Netherlands
Tilburg , 5042 , Netherlands
Zwolle , 8025 , Netherlands
Lørenskog , N-147, Norway
Gerona , 17007, Spain
Madrid , 08035, Spain
Madrid , 28040, Spain
Madrid , 28041, Spain
Malaga , 29010, Spain
Oviedo , 33011, Spain
Sevilla , 41009, Spain
Göteborg , 413 4, Sweden
Solna , 171 6, Sweden
Changhua City , 50006, Taiwan
Kaohsiung , 807, Taiwan
Kaohsiung , 833, Taiwan
Taichung , 404, Taiwan
Taichung , 40705, Taiwan
Tainan , 70403, Taiwan
Taipei , 10002, Taiwan
Taipei , 112, Taiwan
Taoyuan City , 333, Taiwan
Adana , 01120, Turkey
Ankara , 06230, Turkey
Ankara , 06340, Turkey
Ankara , 06590, Turkey
Edirne , 22030, Turkey
Istanbul , 34030, Turkey
Istanbul , 34365, Turkey
Karsiyaka , 35575, Turkey
London , EC1M , United Kingdom
London , NW1 2, United Kingdom
Manchester , M20 4, United Kingdom
Romford , RM7 0, United Kingdom
Sutton , SM25P, United Kingdom
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