Study of Olaparib (Lynparza™) Versus Enzalutamide or Abiraterone Acetate in Men With Metastatic Castration-Resistant Prostate Cancer (PROfound Study)

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)

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.

Study Overview

• Status: Completed
• Conditions: Metastatic Castration-resistant Prostate Cancer
• Intervention / Treatment: Drug: olaparib; Drug: enzalutamide; Drug: abiraterone acetate; Drug: abiraterone acetate; Drug: enzalutamide

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.

• Study Type: Interventional
• Enrollment (Actual): 387
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1120AAT
    • Research Site
  • Buenos Aires, Argentina, C1118AAT
    • Research Site
  • Buenos Aires, Argentina, 1426
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  • Caba, Argentina, C1280AEB
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  • La Rioja, Argentina, 5300
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  • Rosario, Argentina, 2000
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• Australia
  • Adelaide, Australia, 5000
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  • Box Hill, Australia, 3128
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  • Clayton, Australia, 3168
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  • Greenslopes, Australia, 4120
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  • Herston, Australia, 4029
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  • Macquarie University, Australia, 2109
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  • Melbourne, Australia, 3000
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  • Nedlands, Australia, 6009
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  • Randwick, Australia, 2031
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  • Waratah, Australia, 2298
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• Austria
  • Graz, Austria, 8036
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  • Linz, Austria, 4020
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  • Salzburg, Austria, 5020
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  • Wien, Austria, 1090
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  • Wien, Austria, 1020
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• Brazil
  • Barretos, Brazil, 14784-400
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  • Belo Horizonte, Brazil, 30110-022
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  • Curitiba, Brazil, 80530-010
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  • Florianópolis, Brazil, 88034-000
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  • Passo Fundo, Brazil, 99010-080
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  • Porto Alegre, Brazil, 90610-000
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  • Porto Alegre, Brazil, 90160-093
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  • Recife, Brazil, 50040-000
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  • Ribeirao Preto, Brazil, 14015-140
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  • Rio de Janeiro, Brazil, 22793-080
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  • Santo Andre, Brazil, 09060-650
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  • São José do Rio Preto, Brazil, 15090-000
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  • São Paulo, Brazil, 01321-001
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  • São Paulo, Brazil, 03102-002
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• Canada
  • Quebec, Canada, G1J 1Z4
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  • Alberta
    • Edmonton, Alberta, Canada, T6G 1Z2
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  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 5L3
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    • Vancouver, British Columbia, Canada, V5Z 4E6
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  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
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    • Oakville, Ontario, Canada, L6H 3P1
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    • Toronto, Ontario, Canada, M5G 2M9
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    • Toronto, Ontario, Canada, M4N 3M5
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  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
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    • Montreal, Quebec, Canada, H4A 3J1
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    • Montreal, Quebec, Canada, H2X 3E4
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  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7N 4H4
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• Denmark
  • Odense C, Denmark, 5000
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• France
  • BESANCON Cedex, France, 25030
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  • Bordeaux Cedex, France, 33000
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  • Caen, France, 14000
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  • Lille, France, 59020
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  • Lyon Cedex 08, France, 69008
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  • Marseille cedex 09, France, 13273
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  • Montpellier, France, 34298
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  • Paris, France, 75014
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  • Poitiers Cedex, France, 86021
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  • Saint Herblain, France, 44805
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  • Toulouse Cedex 09, France, 31100
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  • Vandoeuvre les Nancy, France, 54519
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  • Villejuif, France, 94805
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• Germany
  • Bergisch Gladbach, Germany, 51465
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  • Berlin, Germany, 13055
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  • Bremen, Germany, 28277
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  • Duisburg, Germany, 47179
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  • Düsseldorf, Germany, 40225
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  • Hamburg, Germany, 22399
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  • Heidelberg, Germany, 69120
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  • Holzminden, Germany, 37603
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  • Jena, Germany, 07747
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  • Köln, Germany, 50968
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  • Magdeburg, Germany, 39120
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  • Nürnberg, Germany, 90491
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  • Nürtingen, Germany, 72622
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  • Tübingen, Germany, 72076
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  • Wuppertal, Germany, 42109
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• Israel
  • Haifa, Israel, 31096
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  • Jerusalem, Israel, 91120
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  • Kfar Saba, Israel, 95847
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  • Petach-Tikva, Israel, 4941492
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  • Ramat Gan, Israel, 5265601
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  • Zerifin, Israel, 70300
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• Italy
  • Ancona, Italy, 60126
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  • Arezzo, Italy, 52100
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  • Bari, Italy, 70124
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  • Brescia, Italy, 25100
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  • Meldola, Italy, 47014
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  • Milano, Italy, 20141
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  • Milano, Italy, 20133
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  • Modena, Italy, 41124
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  • Napoli, Italy, 80131
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  • Trento, Italy, 38100
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• Japan
  • Bunkyo-ku, Japan, 113-8603
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  • Bunkyo-ku, Japan, 113-8431
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  • Bunkyo-ku, Japan, 113-8510
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  • Fukuoka, Japan, 812-8582
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  • Hirosaki-shi, Japan, 036-8563
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  • Kanazawa-shi, Japan, 920-8641
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  • Kashihara-shi, Japan, 634-8522
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  • Kashiwa, Japan, 277-8577
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  • Kawagoe-shi, Japan, 350-8550
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  • Kita-gun, Japan, 761-0793
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  • Koto-ku, Japan, 135-8550
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  • Kyoto-shi, Japan, 606-8507
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  • Maebashi-shi, Japan, 371-8811
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  • Matsuyama-shi, Japan, 791-0280
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  • Minato-ku, Japan, 105-8471
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  • Mitaka-shi, Japan, 181-8611
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  • Miyazaki-shi, Japan, 889-1692
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  • Nagasaki-shi, Japan, 852-8501
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  • Nagoya-shi, Japan, 464-8681
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  • Nagoya-shi, Japan, 466-8560
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  • Osaka-shi, Japan, 541-8567
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  • Osaka-shi, Japan, 545-8586
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  • Osakasayama-shi, Japan, 589-8511
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  • Sagamihara-shi, Japan, 252-0375
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  • Sakura-shi, Japan, 285-8741
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  • Sapporo-shi, Japan, 060-8648
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  • Shinjuku-ku, Japan, 160-8582
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  • Suita-shi, Japan, 565-0871
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  • Sunto-gun, Japan, 411-8777
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  • Yokohama-shi, Japan, 232-0024
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• Korea, Republic of
  • Busan, Korea, Republic of, 49241
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  • Daegu, Korea, Republic of, 41404
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  • Goyang-si, Korea, Republic of, 10408
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  • Gwangju, Korea, Republic of, 61469
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  • Seoul, Korea, Republic of, 03722
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  • Seoul, Korea, Republic of, 05505
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  • Seoul, Korea, Republic of, 06273
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  • Seoul, Korea, Republic of, 06351
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  • Seoul, Korea, Republic of, 06591
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• Netherlands
  • Amsterdam, Netherlands, 1066 CX
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  • Hilversum, Netherlands, 1213 XZ
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  • Leiden, Netherlands, 2333 ZA
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  • Nijmegen, Netherlands, 6525 GA
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  • Tilburg, Netherlands, 5042 AD
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  • Zwolle, Netherlands, 8025 AB
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• Norway
  • Lørenskog, Norway, N-1478
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• Spain
  • Gerona, Spain, 17007
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  • Madrid, Spain, 28041
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  • Madrid, Spain, 28040
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  • Madrid, Spain, 08035
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  • Malaga, Spain, 29010
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  • Oviedo, Spain, 33011
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  • Sevilla, Spain, 41009
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• Sweden
  • Göteborg, Sweden, 413 45
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  • Solna, Sweden, 171 64
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• Taiwan
  • Changhua City, Taiwan, 50006
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  • Kaohsiung, Taiwan, 807
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  • Kaohsiung, Taiwan, 833
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  • Taichung, Taiwan, 40705
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  • Taichung, Taiwan, 404
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  • Tainan, Taiwan, 70403
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  • Taipei, Taiwan, 10002
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  • Taipei, Taiwan, 112
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  • Taoyuan City, Taiwan, 333
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• Turkey
  • Adana, Turkey, 01120
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  • Ankara, Turkey, 06230
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  • Ankara, Turkey, 06590
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  • Ankara, Turkey, 06340
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  • Edirne, Turkey, 22030
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  • Istanbul, Turkey, 34030
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  • Istanbul, Turkey, 34365
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  • Karsiyaka, Turkey, 35575
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• United Kingdom
  • London, United Kingdom, NW1 2PG
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  • London, United Kingdom, EC1M 6BQ
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  • Manchester, United Kingdom, M20 4BX
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  • Romford, United Kingdom, RM7 0BE
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  • Sutton, United Kingdom, SM25PT
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• United States
  • Alaska
    • Anchorage, Alaska, United States, 99503
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  • Arizona
    • Tucson, Arizona, United States, 85704
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    • Tucson, Arizona, United States, 85741
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  • California
    • Duarte, California, United States, 91010
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    • San Diego, California, United States, 92161
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    • Santa Barbara, California, United States, 93105
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  • District of Columbia
    • Washington, District of Columbia, United States, 20007
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  • Florida
    • Tampa, Florida, United States, 33612
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  • Georgia
    • Atlanta, Georgia, United States, 30318
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  • Illinois
    • Chicago, Illinois, United States, 60611
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  • Indiana
    • Jeffersonville, Indiana, United States, 47130
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  • Louisiana
    • New Orleans, Louisiana, United States, 70112
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  • Maryland
    • Baltimore, Maryland, United States, 21287
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    • Towson, Maryland, United States, 21204
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  • Nebraska
    • Omaha, Nebraska, United States, 68130
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  • Nevada
    • Las Vegas, Nevada, United States, 89135
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  • New York
    • Albany, New York, United States, 12208
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    • Bronx, New York, United States, 10468
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    • Brooklyn, New York, United States, 11201
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    • Syracuse, New York, United States, 13210
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  • North Carolina
    • Durham, North Carolina, United States, 27710
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    • Salisbury, North Carolina, United States, 28144
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  • Ohio
    • Columbus, Ohio, United States, 43230
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  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
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  • Oregon
    • Springfield, Oregon, United States, 97477
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    • Tualatin, Oregon, United States, 97062
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  • South Carolina
    • Charleston, South Carolina, United States, 29401
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    • Myrtle Beach, South Carolina, United States, 29572
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  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Research Site
    • Nashville, Tennessee, United States, 37232
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  • Texas
    • San Antonio, Texas, United States, 78229
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  • Utah
    • Salt Lake City, Utah, United States, 84112
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    • Salt Lake City, Utah, United States, 84148
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  • Washington
    • Spokane, Washington, United States, 99202
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  • West Virginia
    • Wheeling, West Virginia, United States, 26003
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria

1. Histologically confirmed diagnosis of prostate cancer.
2. Documented evidence of metastatic castration resistant prostate cancer (mCRPC).
3. 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 .
4. Ongoing therapy with LHRH analog or bilateral orchiectomy.
5. Radiographic progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
6. Qualifying HRR mutation in tumor tissue.

Exclusion criteria

1. Any previous treatment with PARP inhibitor, including olaparib.
2. 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.
3. 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.
4. Subjects with known brain metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Olaparib; Olaparib is available as a film-coated tablet containing 150 mg or 100 mg of olaparib. Subjects will be administered study treatment orally at a dose of 300 mg twice daily (bid). The planned dose of 300 mg bid will be made up of two x 150 mg tablets twice daily, with 100 mg tablets used to manage dose reductions	Drug: olaparib; 300 mg (2x 150 mg tablets) twice daily; Other Names: Lynparza
Active Comparator: Enzalutamide OR abiraterone acetate; Enzalutamide: Enzalutamide is available as capsules or tablets containing 40 mg of enzalutamide. Subjects will be administered study treatment orally at a dose of 160 mg once daily. Abiraterone acetate with prednisone: Abiraterone acetate is available as tablets containing 250 mg or 500 mg of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily in combination with prednisone 5 mg administered twice daily orally. Prednisolone is permitted for use instead of prednisone if necessary.	Drug: enzalutamide; 160 mg (4 x 40 mg capsules) once daily; Other Names: XTANDI; Drug: abiraterone acetate; 1,000 mg (4 x 250 mg tablets) once daily; Other Names: ZYTIGA; Drug: abiraterone acetate; 1,000 mg (2 x 500 mg tablets) once daily; Other Names: ZYTIGA; Drug: enzalutamide; 160 mg (4 x 40 mg tablets) once daily; Other Names: XTANDI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A Only	The time from randomisation until the date of objective radiological disease progression (determined by RECIST 1.1 (soft tissue) and Prostate Cancer Working Group 3 (PCWG-3) (bone)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression. Progression is defined using (i) Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for soft tissue, as a >=20% increase in the sum of diameters of target lesions and an absolute increase of >=5mm taking as reference the smallest sum of diameters since treatment started including the baseline sum of diameters; (ii) Prostate Cancer Working Group 3 (PGWG-3) for bone as >= 2 new bone lesions on the 1st week 8 scan compared to baseline. The confirmatory scan, >=6 weeks later, must show >=2 more new bone lesions (for a total of >=4 new bone lesions since baseline).	Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Objective Response Rate (ORR) by Blinded Independent Central Review (BICR) - Cohort A Only	ORR is the percentage of patients with at least one visit response of Complete response (CR) or Partial response (PR), in their soft tissue disease assessed by Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), in the absence of progression on bone scan assessed by Prostate Cancer Working Group 3 (PCWG3)). Per RECIST v1.1, CR=Disappearance of all target lesions; PR = >=30% decrease in the sum of diameters of target lesions; For each treatment group, ORR is the number of patients with a CR and PR.	Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
Radiological Progression Free Survival (rPFS) by Blinded Independent Central Review (BICR) - Cohort A+B	The time from randomisation until the date of objective radiological disease progression (by RECIST 1.1 and Prostate Cancer Working Group 3 (PGWG-3)) or death (by any cause in the absence of progression) regardless of whether the patient withdrew from randomised therapy or received another anti-cancer therapy prior to progression.	Tumor assessments every 8 weeks from randomisation until radiographic progression assessed by BICR (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
Time to Pain Progression - Cohort A Only	Time from randomisation to time point at which worsening in pain is observed (ie date of pain progression - date of randomisation + 1). Based on average Brief Pain Inventory - short form (BPI-SF) worst pain [Item 3] and Analgesic Quantification Algorithm [AQA] score.	Every 4 weeks from randomisation (for 7 consecutive days) throughout the study (median duration of treatment of 7 and 4 months for Olaparib and Investigators Choice of NHA respectively).
Overall Survival (OS) - Cohort A Only	Number of Participants with Overall Survival (OS) - Cohort A only.	Approximately 35 months after the first patient was randomised.

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Merck Sharp & Dohme LLC; Myriad Genetics, Inc.; Foundation Medicine, Inc.
• Investigators: Principal Investigator: Johann de Bono, M.D., Ph.D., The Institute of Cancer Research, United Kingdom; Principal Investigator: Maha Hussain, M.D., FACP, FASCO, Northwestern University, United States of America

Publications and helpful links

General Publications

• Roubaud G, Ozguroglu M, Penel N, Matsubara N, Mehra N, Kolinsky MP, Procopio G, Feyerabend S, Joung JY, Gravis G, Nishimura K, Gedye C, Padua C, Shore N, Thiery-Vuillemin A, Saad F, van Alphen R, Carducci MA, Desai C, Brickel N, Poehlein C, Del Rosario P, Fizazi K. Olaparib tolerability and common adverse-event management in patients with metastatic castration-resistant prostate cancer: Further analyses from the PROfound study. Eur J Cancer. 2022 Jul;170:73-84. doi: 10.1016/j.ejca.2022.04.016. Epub 2022 May 19.
• Matsubara N, Nishimura K, Kawakami S, Joung JY, Uemura H, Goto T, Kwon TG, Sugimoto M, Kato M, Wang SS, Pang ST, Chen CH, Fujita T, Nii M, Shen L, Dujka M, Hussain M, de Bono J. Olaparib in patients with mCRPC with homologous recombination repair gene alterations: PROfound Asian subset analysis. Jpn J Clin Oncol. 2022 May 5;52(5):441-448. doi: 10.1093/jjco/hyac015.
• Thiery-Vuillemin A, de Bono J, Hussain M, Roubaud G, Procopio G, Shore N, Fizazi K, Dos Anjos G, Gravis G, Joung JY, Matsubara N, Castellano D, Degboe A, Gresty C, Kang J, Allen A, Poehlein C, Saad F. Pain and health-related quality of life with olaparib versus physician's choice of next-generation hormonal drug in patients with metastatic castration-resistant prostate cancer with homologous recombination repair gene alterations (PROfound): an open-label, randomised, phase 3 trial. Lancet Oncol. 2022 Mar;23(3):393-405. doi: 10.1016/S1470-2045(22)00017-1. Epub 2022 Feb 11. Erratum In: Lancet Oncol. 2022 Apr;23(4):e161.
• Hussain M, Corcoran C, Sibilla C, Fizazi K, Saad F, Shore N, Sandhu S, Mateo J, Olmos D, Mehra N, Kolinsky MP, Roubaud G, Ozguroglu M, Matsubara N, Gedye C, Choi YD, Padua C, Kohlmann A, Huisden R, Elvin JA, Kang J, Adelman CA, Allen A, Poehlein C, de Bono J. Tumor Genomic Testing for >4,000 Men with Metastatic Castration-resistant Prostate Cancer in the Phase III Trial PROfound (Olaparib). Clin Cancer Res. 2022 Apr 14;28(8):1518-1530. doi: 10.1158/1078-0432.CCR-21-3940.
• Hussain M, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Roubaud G, Ozguroglu M, Kang J, Burgents J, Gresty C, Corcoran C, Adelman CA, de Bono J; PROfound Trial Investigators. Survival with Olaparib in Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 Dec 10;383(24):2345-2357. doi: 10.1056/NEJMoa2022485. Epub 2020 Sep 20.
• de Bono J, Mateo J, Fizazi K, Saad F, Shore N, Sandhu S, Chi KN, Sartor O, Agarwal N, Olmos D, Thiery-Vuillemin A, Twardowski P, Mehra N, Goessl C, Kang J, Burgents J, Wu W, Kohlmann A, Adelman CA, Hussain M. Olaparib for Metastatic Castration-Resistant Prostate Cancer. N Engl J Med. 2020 May 28;382(22):2091-2102. doi: 10.1056/NEJMoa1911440. Epub 2020 Apr 28.

Helpful Links

• CSP redacted
• redacted SAP
• Redacted CSR synopsis

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2017
• Primary Completion (Actual): June 4, 2019
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: November 15, 2016
• First Submitted That Met QC Criteria: December 6, 2016
• First Posted (Estimated): December 9, 2016

Study Record Updates

• Last Update Posted (Actual): October 6, 2023
• Last Update Submitted That Met QC Criteria: October 4, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: metastatic castration-resistant prostate cancer (mCRPC); homologous recombination repair (HRR)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Poly(ADP-ribose) Polymerase Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Hormone Antagonists; Steroid Synthesis Inhibitors; Olaparib; Abiraterone Acetate
• Other Study ID Numbers: D081DC00007; 2016-000300-28 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No