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)


Condition: Metastatic Castration-resistant Prostate Cancer

Intervention:

  • Drug: olaparib
  • Drug: enzalutamide
  • Drug: abiraterone acetate
  • Drug: abiraterone acetate

Purpose: 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 Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT02987543

Sponsor: AstraZeneca

Primary Outcome Measures:

  • Measure: Change in radiographic progression free survival (rPFS)
  • Time Frame: During study period (up to 3 years)
  • Safety Issue:

Secondary Outcome Measures:

  • Measure: Confirmed Objective Response Rate (ORR) by BICR
  • Time Frame: During study period (up to 3 years)
  • Safety Issue:
  • Measure: Time to Pain progression
  • Time Frame: To be completed by subject daily for 7 consecutive days before each respective 4-week visit/assessment date with Day 1 as the baseline visit date (not required to be at site)
  • Safety Issue:
  • Measure: Overall Survival (OS)
  • Time Frame: During study period (up to 4 years)
  • Safety Issue:
  • Measure: rPFS
  • Time Frame: During study period (up to 3 years)
  • Safety Issue:
  • Measure: AEs/SAEs and Collection of clinical chemistry/hematology parameters
  • Time Frame: From the time of signature of informed consent throughout the treatment period up to and including the 30-day follow-up period.
  • Safety Issue:

Estimated Enrollment: 340

Study Start Date: February 6, 2017

Phase: Phase 3

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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.

Contact:

  • AstraZeneca Clinical Study Information Center
  • 1-877-240-9479

Locations:

  • Research Site
  • Anchorage Alaska 99503 United States
  • Research Site
  • Tucson Arizona 85704 United States
  • Research Site
  • Tucson Arizona 85741 United States
  • Research Site
  • Duarte California 91010 United States
  • Research Site
  • San Bernardino California 92404 United States
  • Research Site
  • San Diego California 92123 United States
  • Research Site
  • San Diego California 92161 United States
  • Research Site
  • Santa Barbara California 93105 United States
  • Research Site
  • Santa Rosa California 95403 United States
  • Research Site
  • Washington District of Columbia 20007 United States
  • Research Site
  • Washington District of Columbia 20016 United States
  • Research Site
  • Tampa Florida 33612 United States
  • Research Site
  • Atlanta Georgia 30318 United States
  • Research Site
  • Atlanta Georgia 30322 United States
  • Research Site
  • Chicago Illinois 60611 United States
  • Research Site
  • Jeffersonville Indiana 47130 United States
  • Research Site
  • New Orleans Louisiana 70112 United States
  • Research Site
  • Baltimore Maryland 21287 United States
  • Research Site
  • Towson Maryland 21204 United States
  • Research Site
  • Minneapolis Minnesota 55454 United States
  • Research Site
  • Kansas City Missouri 64128 United States
  • Research Site
  • Omaha Nebraska 68130 United States
  • Research Site
  • Las Vegas Nevada 89135 United States
  • Research Site
  • Santa Fe New Mexico 87505 United States
  • Research Site
  • Albany New York 12208 United States
  • Research Site
  • Bronx New York 10468 United States
  • Research Site
  • Brooklyn New York 11201 United States
  • Research Site
  • Syracuse New York 13210 United States
  • Research Site
  • Durham North Carolina 27710 United States
  • Research Site
  • Salisbury North Carolina 28144 United States
  • Research Site
  • Gahanna Ohio 43230 United States
  • Research Site
  • Oklahoma City Oklahoma 73104 United States
  • Research Site
  • Springfield Oregon 97477 United States
  • Research Site
  • Tualatin Oregon 97062 United States
  • Research Site
  • Hershey Pennsylvania 17033 United States
  • Research Site
  • Pittsburgh Pennsylvania 15212 United States
  • Research Site
  • Charleston South Carolina 29401 United States
  • Research Site
  • Charleston South Carolina 29425 United States
  • Research Site
  • Myrtle Beach South Carolina 29572 United States
  • Research Site
  • Germantown Tennessee 38138 United States
  • Research Site
  • Nashville Tennessee 37232 United States
  • Research Site
  • San Antonio Texas 78229 United States
  • Research Site
  • Salt Lake City Utah 84112 United States
  • Research Site
  • Salt Lake City Utah 84148 United States
  • Research Site
  • Spokane Washington 99202 United States
  • Research Site
  • Wheeling West Virginia 26041 United States
  • Research Site
  • Buenos Aires 1426 Argentina
  • Research Site
  • Buenos Aires C1118AAT Argentina
  • Research Site
  • Buenos Aires C1120AAT Argentina
  • Research Site
  • Caba 1280AEB Argentina
  • Research Site
  • Cordoba 5000 Argentina
  • Research Site
  • La Rioja 5300 Argentina
  • Research Site
  • Rosario Argentina
  • Research Site
  • Viedma R8500ACE Argentina
  • Research Site
  • Adelaide 5000 Australia
  • Research Site
  • Box Hill 3128 Australia
  • Research Site
  • Clayton 3168 Australia
  • Research Site
  • Greenslopes 4120 Australia
  • Research Site
  • Herston 4029 Australia
  • Research Site
  • Macquarie University 2109 Australia
  • Research Site
  • Melbourne 3000 Australia
  • Research Site
  • Nedlands 6009 Australia
  • Research Site
  • Randwick 2031 Australia
  • Research Site
  • Waratah 2298 Australia
  • Research Site
  • Graz 8036 Austria
  • Research Site
  • Innsbruck 6020 Austria
  • Research Site
  • Linz 4010 Austria
  • Research Site
  • Salzburg 5020 Austria
  • Research Site
  • Wien 1020 Austria
  • Research Site
  • Wien 1090 Austria
  • Research Site
  • Wien 1090 Austria
  • Research Site
  • Barretos 14784-400 Brazil
  • Research Site
  • Belo Horizonte 30150-270 Brazil
  • Research Site
  • Curitiba 80530-010 Brazil
  • Research Site
  • Florianópolis 88034-000 Brazil
  • Research Site
  • Passo Fundo 99010-080 Brazil
  • Research Site
  • Porto Alegre 90160-093 Brazil
  • Research Site
  • Porto Alegre 90610-000 Brazil
  • Research Site
  • Recife 50040-000 Brazil
  • Research Site
  • Ribeirao Preto 14015-140 Brazil
  • Research Site
  • Rio de Janeiro 22793-080 Brazil
  • Research Site
  • Santo Andre 09060-650 Brazil
  • Research Site
  • Sao Paulo 01509-010 Brazil
  • Research Site
  • São José do Rio Preto 15090-000 Brazil
  • Research Site
  • São Paulo 01308-050 Brazil
  • Research Site
  • São Paulo 01321-001 Brazil
  • Research Site
  • São Paulo 03102-002 Brazil
  • Research Site
  • Edmonton Alberta T6G 1Z2 Canada
  • Research Site
  • Kelowna British Columbia V1Y 5L3 Canada
  • Research Site
  • Vancouver British Columbia V5Z 4E6 Canada
  • Research Site
  • Victoria British Columbia V8R 6V5 Canada
  • Research Site
  • Hamilton Ontario L8V 5C2 Canada
  • Research Site
  • Oakville Ontario L6H 3P1 Canada
  • Research Site
  • Toronto Ontario M4N 3M5 Canada
  • Research Site
  • Toronto Ontario M5G 2M9 Canada
  • Research Site
  • Chicoutimi Quebec G7H 5H6 Canada
  • Research Site
  • Montreal Quebec H2X 3E4 Canada
  • Research Site
  • Montreal Quebec H4A 3J1 Canada
  • Research Site
  • Saskatoon Saskatchewan S7N 4H4 Canada
  • Research Site
  • Quebec G1R 2J6 Canada
  • Research Site
  • Beijing 100034 China
  • Research Site
  • Beijing 100039 China
  • Research Site
  • Beijing 100050 China
  • Research Site
  • Beijing 100191 China
  • Research Site
  • Beijing 100730 China
  • Research Site
  • Beijing China
  • Research Site
  • Changsha 410008 China
  • Research Site
  • Changsha 410013 China
  • Research Site
  • Chengdu 610041 China
  • Research Site
  • Chongqing 400010 China
  • Research Site
  • ChongQing 400038 China
  • Research Site
  • Guang Zhou 510080 China
  • Research Site
  • Hangzhou 310009 China
  • Research Site
  • Hangzhou 310014 China
  • Research Site
  • Nanjing 210008 China
  • Research Site
  • Shanghai 200040 China
  • Research Site
  • Shanghai 200080 China
  • Research Site
  • Shanghai 200127 China
  • Research Site
  • Shanghai 200433 China
  • Research Site
  • Shanghai CN-200092 China
  • Research Site
  • Shenyang 110001 China
  • Research Site
  • Suzhou 215004 China
  • Research Site
  • Wuhan CN-430070 China
  • Research Site
  • Xi'an 710061 China
  • Research Site
  • Xiamen 361003 China
  • Research Site
  • Herlev 2730 Denmark
  • Research Site
  • Odense C 5000 Denmark
  • Research Site
  • Ålborg 9100 Denmark
  • Research Site
  • BESANCON Cedex 25030 France
  • Research Site
  • Bordeaux Cedex 33076 France
  • Research Site
  • Caen 14000 France
  • Research Site
  • Lille 59020 France
  • Research Site
  • Lyon Cedex 08 69373 France
  • Research Site
  • Marseille cedex 09 13273 France
  • Research Site
  • Montpellier 34298 France
  • Research Site
  • Paris 75014 France
  • Research Site
  • Poitiers Cedex 86021 France
  • Research Site
  • Saint Herblain 44805 France
  • Research Site
  • Toulouse Cedex 09 31059 France
  • Research Site
  • Vandoeuvre les Nancy 54519 France
  • Research Site
  • Villejuif Cedex 94805 France
  • Research Site
  • Bergisch Gladbach 51465 Germany
  • Research Site
  • Berlin 13055 Germany
  • Research Site
  • Bremen 28277 Germany
  • Research Site
  • Duisburg 47179 Germany
  • Research Site
  • Düsseldorf 40225 Germany
  • Research Site
  • Hamburg 22399 Germany
  • Research Site
  • Hannover 30625 Germany
  • Research Site
  • Heidelberg 69120 Germany
  • Research Site
  • Holzminden 37603 Germany
  • Research Site
  • Jena 07747 Germany
  • Research Site
  • Köln 50968 Germany
  • Research Site
  • Magdeburg 39120 Germany
  • Research Site
  • Nürnberg 90491 Germany
  • Research Site
  • Nürtingen 72766 Germany
  • Research Site
  • Tübingen 72076 Germany
  • Research Site
  • Wuppertal 42109 Germany
  • Research Site
  • Haifa 31096 Israel
  • Research Site
  • Jerusalem 91120 Israel
  • Research Site
  • Kfar Saba 95847 Israel
  • Research Site
  • Petach-Tikva 4941492 Israel
  • Research Site
  • Ramat Gan 5265601 Israel
  • Research Site
  • Zerifin 70300 Israel
  • Research Site
  • Ancona 60126 Italy
  • Research Site
  • Arezzo 52100 Italy
  • Research Site
  • Bari 70124 Italy
  • Research Site
  • Brescia 25123 Italy
  • Research Site
  • Meldola 47014 Italy
  • Research Site
  • Milano 20133 Italy
  • Research Site
  • Milano 20141 Italy
  • Research Site
  • Modena 41124 Italy
  • Research Site
  • Napoli 80131 Italy
  • Research Site
  • Trento 38100 Italy
  • Research Site
  • Bunkyo-ku 113-8431 Japan
  • Research Site
  • Bunkyo-ku 113-8510 Japan
  • Research Site
  • Bunkyo-ku 113-8603 Japan
  • Research Site
  • Fukuoka 812-8582 Japan
  • Research Site
  • Hirosaki-shi 036-8563 Japan
  • Research Site
  • Kanazawa-shi 920-8641 Japan
  • Research Site
  • Kashihara-shi 634-0813 Japan
  • Research Site
  • Kashiwa 277-8577 Japan
  • Research Site
  • Kawagoe-shi 350-8550 Japan
  • Research Site
  • Kita-gun 761-0793 Japan
  • Research Site
  • Koto-ku 135-8550 Japan
  • Research Site
  • Kyoto-shi 606-8507 Japan
  • Research Site
  • Maebashi-shi 371-8811 Japan
  • Research Site
  • Matsuyama-shi 791-0280 Japan
  • Research Site
  • Minato-ku 105-8471 Japan
  • Research Site
  • Mitaka-shi 181-8611 Japan
  • Research Site
  • Miyazaki-shi 889-1692 Japan
  • Research Site
  • Nagasaki-shi 852-8501 Japan
  • Research Site
  • Nagoya-shi 464-8681 Japan
  • Research Site
  • Nagoya-shi 466-8560 Japan
  • Research Site
  • Osaka-shi 541-8567 Japan
  • Research Site
  • Osaka-shi 545-0051 Japan
  • Research Site
  • Osakasayama-shi 589-8511 Japan
  • Research Site
  • Sagamihara-shi 252-0375 Japan
  • Research Site
  • Sakura-shi 285-8741 Japan
  • Research Site
  • Sapporo-shi 060-8648 Japan
  • Research Site
  • Shinjuku-ku 160-8582 Japan
  • Research Site
  • Suita-shi 565-0871 Japan
  • Research Site
  • Sunto-gun 411-8777 Japan
  • Research Site
  • Yokohama-shi 232-0024 Japan
  • Research Site
  • Busan 49241 Korea, Republic of
  • Research Site
  • Daegu 41404 Korea, Republic of
  • Research Site
  • Goyang-si 10408 Korea, Republic of
  • Research Site
  • Gwangju 61469 Korea, Republic of
  • Research Site
  • Seoul 03080 Korea, Republic of
  • Research Site
  • Seoul 03722 Korea, Republic of
  • Research Site
  • Seoul 05505 Korea, Republic of
  • Research Site
  • Seoul 06273 Korea, Republic of
  • Research Site
  • Seoul 06351 Korea, Republic of
  • Research Site
  • Seoul 06591 Korea, Republic of
  • Research Site
  • Amsterdam 1066 CX Netherlands
  • Research Site
  • Hilversum 1213 XZ Netherlands
  • Research Site
  • Leiden 2333 ZA Netherlands
  • Research Site
  • Nijmegen 6525 GA Netherlands
  • Research Site
  • Tilburg 5042 AD Netherlands
  • Research Site
  • Zwolle 8025 AB Netherlands
  • Research Site
  • Lørenskog N-1478 Norway
  • Research Site
  • Barcelona 08035 Spain
  • Research Site
  • Gerona 17007 Spain
  • Research Site
  • Madrid 28040 Spain
  • Research Site
  • Madrid 28041 Spain
  • Research Site
  • Madrid 28050 Spain
  • Research Site
  • Malaga 29010 Spain
  • Research Site
  • Oviedo 33011 Spain
  • Research Site
  • Sevilla 41009 Spain
  • Research Site
  • Göteborg 413 45 Sweden
  • Research Site
  • Solna 171 64 Sweden
  • Research Site
  • Changhua City 50006 Taiwan
  • Research Site
  • Kaohsiung 807 Taiwan
  • Research Site
  • Kaohsiung 833 Taiwan
  • Research Site
  • Taichung 404 Taiwan
  • Research Site
  • Taichung 40705 Taiwan
  • Research Site
  • Tainan 70403 Taiwan
  • Research Site
  • Taipei 100 Taiwan
  • Research Site
  • Taipei 112 Taiwan
  • Research Site
  • Taoyuan City 333 Taiwan
  • Research Site
  • Adana Turkey
  • Research Site
  • Ankara 06230 Turkey
  • Research Site
  • Ankara 06340 Turkey
  • Research Site
  • Ankara 06590 Turkey
  • Research Site
  • Edirne 22030 Turkey
  • Research Site
  • Istanbul 34030 Turkey
  • Research Site
  • Istanbul 34365 Turkey
  • Research Site
  • Karsiyaka 35575 Turkey
  • Research Site
  • London EC1M 6BQ United Kingdom
  • Research Site
  • London NW1 2PG United Kingdom
  • Research Site
  • Manchester M20 4BX United Kingdom
  • Research Site
  • Romford RM7 0BE United Kingdom
  • Research Site
  • Sutton SM25PT United Kingdom

View trial on ClinicalTrials.gov