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ACTIVE NOT RECRUITING
NCT05457257
PHASE4

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

View on ClinicalTrials.gov

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

DRUG

olaparib

300 mg (2x 150 mg tablets) twice daily

DRUG

enzalutamide

160 mg (4 x 40 mg capsules) once daily

DRUG

abiraterone acetate

1,000 mg (4 x 250 mg tablets) once daily

DRUG

Prednisone

5mg(5mg x 1 tablet) twice daily

Locations (35)

Research Site

Beijing, China

Research Site

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

Research Site

Hangzhou, China

Research Site

Hangzhou, China

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Hangzhou, China

Research Site

Hefei, China

Research Site

Jiaxing, China

Research Site

Jinan, China

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Jinan, China

Research Site

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

Research Site

Zhengzhou, China