Spots Global Cancer Trial Database for Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
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Trial Identification
Brief Title: Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)
Official Title: A Phase III, Open Label, Randomized Study to Assess the Efficacy and Safety of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have Homologous Recombination Repair Gene Mutations (PROfound)
Study ID: NCT02987543
Study Description
Brief 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.
Detailed 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
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: MALE
Healthy Volunteers: No
Locations
Research Site, Anchorage, Alaska, United States
Research Site, Tucson, Arizona, United States
Research Site, Tucson, Arizona, United States
Research Site, Duarte, California, United States
Research Site, San Diego, California, United States
Research Site, Santa Barbara, California, United States
Research Site, Washington, District of Columbia, United States
Research Site, Tampa, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Jeffersonville, Indiana, United States
Research Site, New Orleans, Louisiana, United States
Research Site, Baltimore, Maryland, United States
Research Site, Towson, Maryland, United States
Research Site, Omaha, Nebraska, United States
Research Site, Las Vegas, Nevada, United States
Research Site, Albany, New York, United States
Research Site, Bronx, New York, United States
Research Site, Brooklyn, New York, United States
Research Site, Syracuse, New York, United States
Research Site, Durham, North Carolina, United States
Research Site, Salisbury, North Carolina, United States
Research Site, Columbus, Ohio, United States
Research Site, Oklahoma City, Oklahoma, United States
Research Site, Springfield, Oregon, United States
Research Site, Tualatin, Oregon, United States
Research Site, Charleston, South Carolina, United States
Research Site, Myrtle Beach, South Carolina, United States
Research Site, Germantown, Tennessee, United States
Research Site, Nashville, Tennessee, United States
Research Site, San Antonio, Texas, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Salt Lake City, Utah, United States
Research Site, Spokane, Washington, United States
Research Site, Wheeling, West Virginia, United States
Research Site, Buenos Aires, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Buenos Aires, , Argentina
Research Site, Caba, , Argentina
Research Site, La Rioja, , Argentina
Research Site, Rosario, , Argentina
Research Site, Adelaide, , Australia
Research Site, Box Hill, , Australia
Research Site, Clayton, , Australia
Research Site, Greenslopes, , Australia
Research Site, Herston, , Australia
Research Site, Macquarie University, , Australia
Research Site, Melbourne, , Australia
Research Site, Nedlands, , Australia
Research Site, Randwick, , Australia
Research Site, Waratah, , Australia
Research Site, Graz, , Austria
Research Site, Linz, , Austria
Research Site, Salzburg, , Austria
Research Site, Wien, , Austria
Research Site, Wien, , Austria
Research Site, Barretos, , Brazil
Research Site, Belo Horizonte, , Brazil
Research Site, Curitiba, , Brazil
Research Site, Florianópolis, , Brazil
Research Site, Passo Fundo, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Porto Alegre, , Brazil
Research Site, Recife, , Brazil
Research Site, Ribeirao Preto, , Brazil
Research Site, Rio de Janeiro, , Brazil
Research Site, Santo Andre, , Brazil
Research Site, São José do Rio Preto, , Brazil
Research Site, São Paulo, , Brazil
Research Site, São Paulo, , Brazil
Research Site, Edmonton, Alberta, Canada
Research Site, Kelowna, British Columbia, Canada
Research Site, Vancouver, British Columbia, Canada
Research Site, Hamilton, Ontario, Canada
Research Site, Oakville, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Toronto, Ontario, Canada
Research Site, Chicoutimi, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Montreal, Quebec, Canada
Research Site, Saskatoon, Saskatchewan, Canada
Research Site, Quebec, , Canada
Research Site, Odense C, , Denmark
Research Site, BESANCON Cedex, , France
Research Site, Bordeaux Cedex, , France
Research Site, Caen, , France
Research Site, Lille, , France
Research Site, Lyon Cedex 08, , France
Research Site, Marseille cedex 09, , France
Research Site, Montpellier, , France
Research Site, Paris, , France
Research Site, Poitiers Cedex, , France
Research Site, Saint Herblain, , France
Research Site, Toulouse Cedex 09, , France
Research Site, Vandoeuvre les Nancy, , France
Research Site, Villejuif, , France
Research Site, Bergisch Gladbach, , Germany
Research Site, Berlin, , Germany
Research Site, Bremen, , Germany
Research Site, Duisburg, , Germany
Research Site, Düsseldorf, , Germany
Research Site, Hamburg, , Germany
Research Site, Heidelberg, , Germany
Research Site, Holzminden, , Germany
Research Site, Jena, , Germany
Research Site, Köln, , Germany
Research Site, Magdeburg, , Germany
Research Site, Nürnberg, , Germany
Research Site, Nürtingen, , Germany
Research Site, Tübingen, , Germany
Research Site, Wuppertal, , Germany
Research Site, Haifa, , Israel
Research Site, Jerusalem, , Israel
Research Site, Kfar Saba, , Israel
Research Site, Petach-Tikva, , Israel
Research Site, Ramat Gan, , Israel
Research Site, Zerifin, , Israel
Research Site, Ancona, , Italy
Research Site, Arezzo, , Italy
Research Site, Bari, , Italy
Research Site, Brescia, , Italy
Research Site, Meldola, , Italy
Research Site, Milano, , Italy
Research Site, Milano, , Italy
Research Site, Modena, , Italy
Research Site, Napoli, , Italy
Research Site, Trento, , Italy
Research Site, Bunkyo-ku, , Japan
Research Site, Bunkyo-ku, , Japan
Research Site, Bunkyo-ku, , Japan
Research Site, Fukuoka, , Japan
Research Site, Hirosaki-shi, , Japan
Research Site, Kanazawa-shi, , Japan
Research Site, Kashihara-shi, , Japan
Research Site, Kashiwa, , Japan
Research Site, Kawagoe-shi, , Japan
Research Site, Kita-gun, , Japan
Research Site, Koto-ku, , Japan
Research Site, Kyoto-shi, , Japan
Research Site, Maebashi-shi, , Japan
Research Site, Matsuyama-shi, , Japan
Research Site, Minato-ku, , Japan
Research Site, Mitaka-shi, , Japan
Research Site, Miyazaki-shi, , Japan
Research Site, Nagasaki-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Nagoya-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osaka-shi, , Japan
Research Site, Osakasayama-shi, , Japan
Research Site, Sagamihara-shi, , Japan
Research Site, Sakura-shi, , Japan
Research Site, Sapporo-shi, , Japan
Research Site, Shinjuku-ku, , Japan
Research Site, Suita-shi, , Japan
Research Site, Sunto-gun, , Japan
Research Site, Yokohama-shi, , Japan
Research Site, Busan, , Korea, Republic of
Research Site, Daegu, , Korea, Republic of
Research Site, Goyang-si, , Korea, Republic of
Research Site, Gwangju, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Seoul, , Korea, Republic of
Research Site, Amsterdam, , Netherlands
Research Site, Hilversum, , Netherlands
Research Site, Leiden, , Netherlands
Research Site, Nijmegen, , Netherlands
Research Site, Tilburg, , Netherlands
Research Site, Zwolle, , Netherlands
Research Site, Lørenskog, , Norway
Research Site, Gerona, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Madrid, , Spain
Research Site, Malaga, , Spain
Research Site, Oviedo, , Spain
Research Site, Sevilla, , Spain
Research Site, Göteborg, , Sweden
Research Site, Solna, , Sweden
Research Site, Changhua City, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Kaohsiung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Taichung, , Taiwan
Research Site, Tainan, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taipei, , Taiwan
Research Site, Taoyuan City, , Taiwan
Research Site, Adana, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Ankara, , Turkey
Research Site, Edirne, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Istanbul, , Turkey
Research Site, Karsiyaka, , Turkey
Research Site, London, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Research Site, Romford, , United Kingdom
Research Site, Sutton, , United Kingdom
Contact Details
Name: Johann de Bono, M.D., Ph.D.
Affiliation: The Institute of Cancer Research, United Kingdom
Role: PRINCIPAL_INVESTIGATOR
Name: Maha Hussain, M.D., FACP, FASCO
Affiliation: Northwestern University, United States of America
Role: PRINCIPAL_INVESTIGATOR
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