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Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations
Sponsor: AstraZeneca
Summary
The purpose of this study is to evaluate the efficacy and safety of Olaparib compared with standard of care (Enzalutamide or Abiraterone Acetate) in Chinese men with metastatic castration-resistant prostate cancer who have failed prior treatment with a new hormonal agent and have BRCA1/2 mutations.
Official title: A Randomized, Open-label Study to Assess the Efficacy and Safety of Olaparib Versus Enzalutamide or Abiraterone Acetate in Chinese Men With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations (PROfound-CN)
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
43
Start Date
2022-07-29
Completion Date
2026-12-31
Last Updated
2026-04-21
Healthy Volunteers
No
Interventions
olaparib
300 mg (2x 150 mg tablets) twice daily
enzalutamide
160 mg (4 x 40 mg capsules) once daily
abiraterone acetate
1,000 mg (4 x 250 mg tablets) once daily
Prednisone
5mg(5mg x 1 tablet) twice daily
Locations (35)
Research Site
Beijing, China
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Bengbu, China
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Changsha, China
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Changsha, China
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Chengdu, China
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Chongqing, China
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Fuzhou, China
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Guangzhou, China
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Guangzhou, China
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Hangzhou, China
Research Site
Hangzhou, China
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Hangzhou, China
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Hefei, China
Research Site
Jiaxing, China
Research Site
Jinan, China
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Jinan, China
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Jining, China
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Kunming, China
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Lanzhou, China
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Linyi, China
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Nanchang, China
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Nantong, China
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Ningbo, China
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Shanghai, China
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Shanghai, China
Research Site
Shenyang, China
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Suzhou, China
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Taiyuan, China
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Tianjin, China
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Wanzhou, China
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Wuhan, China
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Wuxi, China
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Wuxi, China
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Xi'an, China
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Zhengzhou, China