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.

View Full Description

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.

View Eligibility Criteria

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

387

Study ID:

NCT02987543

Recruitment Status:

Completed

Sponsor:

AstraZeneca

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There are 201 Locations for this study

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Anchorage Alaska, 99503, United States
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Tucson Arizona, 85704, United States
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Tucson Arizona, 85741, United States
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Duarte California, 91010, United States
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San Diego California, 92161, United States
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Santa Barbara California, 93105, United States
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Washington District of Columbia, 20007, United States
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Tampa Florida, 33612, United States
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Atlanta Georgia, 30318, United States
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Chicago Illinois, 60611, United States
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Jeffersonville Indiana, 47130, United States
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New Orleans Louisiana, 70112, United States
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Baltimore Maryland, 21287, United States
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Towson Maryland, 21204, United States
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Omaha Nebraska, 68130, United States
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Las Vegas Nevada, 89135, United States
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Albany New York, 12208, United States
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Bronx New York, 10468, United States
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Brooklyn New York, 11201, United States
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Syracuse New York, 13210, United States
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Durham North Carolina, 27710, United States
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Salisbury North Carolina, 28144, United States
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Columbus Ohio, 43230, United States
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Oklahoma City Oklahoma, 73104, United States
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Springfield Oregon, 97477, United States
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Tualatin Oregon, 97062, United States
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Charleston South Carolina, 29401, United States
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Myrtle Beach South Carolina, 29572, United States
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Germantown Tennessee, 38138, United States
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Nashville Tennessee, 37232, United States
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San Antonio Texas, 78229, United States
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Salt Lake City Utah, 84112, United States
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Salt Lake City Utah, 84148, United States
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Spokane Washington, 99202, United States
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Wheeling West Virginia, 26003, United States
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Buenos Aires , 1426, Argentina
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Buenos Aires , C1118, Argentina
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Buenos Aires , C1120, Argentina
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Caba , C1280, Argentina
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La Rioja , 5300, Argentina
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Rosario , 2000, Argentina
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Adelaide , 5000, Australia
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Box Hill , 3128, Australia
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Clayton , 3168, Australia
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Greenslopes , 4120, Australia
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Herston , 4029, Australia
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Macquarie University , 2109, Australia
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Melbourne , 3000, Australia
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Nedlands , 6009, Australia
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Randwick , 2031, Australia
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Waratah , 2298, Australia
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Graz , 8036, Austria
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Linz , 4020, Austria
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Salzburg , 5020, Austria
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Wien , 1020, Austria
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Wien , 1090, Austria
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Barretos , 14784, Brazil
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Belo Horizonte , 30110, Brazil
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Curitiba , 80530, Brazil
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Florianópolis , 88034, Brazil
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Passo Fundo , 99010, Brazil
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Porto Alegre , 90160, Brazil
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Porto Alegre , 90610, Brazil
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Recife , 50040, Brazil
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Ribeirao Preto , 14015, Brazil
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Rio de Janeiro , 22793, Brazil
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Santo Andre , 09060, Brazil
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São José do Rio Preto , 15090, Brazil
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São Paulo , 01321, Brazil
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São Paulo , 03102, Brazil
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Edmonton Alberta, T6G 1, Canada
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Kelowna British Columbia, V1Y 5, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Hamilton Ontario, L8V 5, Canada
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Oakville Ontario, L6H 3, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Chicoutimi Quebec, G7H 5, Canada
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Montreal Quebec, H2X 3, Canada
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Montreal Quebec, H4A 3, Canada
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Saskatoon Saskatchewan, S7N 4, Canada
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Quebec , G1J 1, Canada
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Odense C , 5000, Denmark
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BESANCON Cedex , 25030, France
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Bordeaux Cedex , 33000, France
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Caen , 14000, France
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Lille , 59020, France
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Lyon Cedex 08 , 69008, France
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Marseille cedex 09 , 13273, France
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Montpellier , 34298, France
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Paris , 75014, France
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Poitiers Cedex , 86021, France
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Saint Herblain , 44805, France
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Toulouse Cedex 09 , 31100, France
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Vandoeuvre les Nancy , 54519, France
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Villejuif , 94805, France
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Bergisch Gladbach , 51465, Germany
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Berlin , 13055, Germany
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Bremen , 28277, Germany
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Duisburg , 47179, Germany
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Düsseldorf , 40225, Germany
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Hamburg , 22399, Germany
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Heidelberg , 69120, Germany
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Holzminden , 37603, Germany
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Jena , 07747, Germany
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Köln , 50968, Germany
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Magdeburg , 39120, Germany
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Nürnberg , 90491, Germany
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Nürtingen , 72622, Germany
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Tübingen , 72076, Germany
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Wuppertal , 42109, Germany
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Haifa , 31096, Israel
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Jerusalem , 91120, Israel
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Kfar Saba , 95847, Israel
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Petach-Tikva , 49414, Israel
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Ramat Gan , 52656, Israel
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Zerifin , 70300, Israel
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Ancona , 60126, Italy
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Arezzo , 52100, Italy
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Bari , 70124, Italy
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Brescia , 25100, Italy
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Meldola , 47014, Italy
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Milano , 20133, Italy
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Milano , 20141, Italy
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Modena , 41124, Italy
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Napoli , 80131, Italy
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Trento , 38100, Italy
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Bunkyo-ku , 113-8, Japan
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Bunkyo-ku , 113-8, Japan
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Bunkyo-ku , 113-8, Japan
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Fukuoka , 812-8, Japan
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Hirosaki-shi , 036-8, Japan
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Kanazawa-shi , 920-8, Japan
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Kashihara-shi , 634-8, Japan
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Kashiwa , 277-8, Japan
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Kawagoe-shi , 350-8, Japan
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Kita-gun , 761-0, Japan
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Koto-ku , 135-8, Japan
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Kyoto-shi , 606-8, Japan
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Maebashi-shi , 371-8, Japan
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Matsuyama-shi , 791-0, Japan
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Minato-ku , 105-8, Japan
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Mitaka-shi , 181-8, Japan
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Miyazaki-shi , 889-1, Japan
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Nagasaki-shi , 852-8, Japan
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Nagoya-shi , 464-8, Japan
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Nagoya-shi , 466-8, Japan
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Osaka-shi , 541-8, Japan
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Osaka-shi , 545-8, Japan
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Osakasayama-shi , 589-8, Japan
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Sagamihara-shi , 252-0, Japan
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Sakura-shi , 285-8, Japan
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Sapporo-shi , 060-8, Japan
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Shinjuku-ku , 160-8, Japan
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Suita-shi , 565-0, Japan
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Sunto-gun , 411-8, Japan
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Yokohama-shi , 232-0, Japan
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Busan , 49241, Korea, Republic of
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Daegu , 41404, Korea, Republic of
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Goyang-si , 10408, Korea, Republic of
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Gwangju , 61469, Korea, Republic of
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Seoul , 03722, Korea, Republic of
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Seoul , 05505, Korea, Republic of
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Seoul , 06273, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Seoul , 06591, Korea, Republic of
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Amsterdam , 1066 , Netherlands
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Hilversum , 1213 , Netherlands
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Leiden , 2333 , Netherlands
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Nijmegen , 6525 , Netherlands
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Tilburg , 5042 , Netherlands
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Zwolle , 8025 , Netherlands
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Lørenskog , N-147, Norway
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Gerona , 17007, Spain
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Madrid , 08035, Spain
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Madrid , 28040, Spain
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Madrid , 28041, Spain
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Malaga , 29010, Spain
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Oviedo , 33011, Spain
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Sevilla , 41009, Spain
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Göteborg , 413 4, Sweden
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Solna , 171 6, Sweden
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Changhua City , 50006, Taiwan
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Kaohsiung , 807, Taiwan
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Kaohsiung , 833, Taiwan
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Taichung , 404, Taiwan
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Taichung , 40705, Taiwan
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Tainan , 70403, Taiwan
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Taipei , 10002, Taiwan
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Taipei , 112, Taiwan
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Taoyuan City , 333, Taiwan
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Adana , 01120, Turkey
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Ankara , 06230, Turkey
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Ankara , 06340, Turkey
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Ankara , 06590, Turkey
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Edirne , 22030, Turkey
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Istanbul , 34030, Turkey
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Istanbul , 34365, Turkey
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Karsiyaka , 35575, Turkey
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London , EC1M , United Kingdom
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London , NW1 2, United Kingdom
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Manchester , M20 4, United Kingdom
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Romford , RM7 0, United Kingdom
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Sutton , SM25P, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

387

Study ID:

NCT02987543

Recruitment Status:

Completed

Sponsor:


AstraZeneca

How clear is this clinincal trial information?

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