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
Study identifier:D081LC00002
ClinicalTrials.gov identifier:NCT05457257
EudraCT identifier:N/A
CTIS identifier:N/A
Recruitment Complete
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)
Medical condition
metastatic castration-resistant prostate cancer
Phase
Phase 4
Healthy volunteers
No
Study drug
olaparib, enzalutamide, abiraterone acetate, Prednisone
Sex
Male
Actual Enrollment
43
Study type
Interventional
Age
18 Years - n/a
Date
Study Start Date: 29 Jul 2022
Primary Completion Date: 22 Oct 2024
Estimated Study Completion Date: 30 Sept 2025
Study design
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verification:
Verified 01 Oct 2024 by AstraZeneca
Sponsors
AstraZeneca
Collaborators
Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co, Inc., Foundation Medicine, Inc., Myriad Genetics, Inc.
Inclusion and exclusion criteria
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No locations available
| Arms | Assigned Interventions |
|---|---|
| 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 Name: 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 of abiraterone acetate. Subjects will be administered study treatment orally at a dose of 1,000 mg once daily. Prednisone is 5mg twice daily. Prednisolone is permitted for use instead of prednisone if necessary. | Drug: enzalutamide 160 mg (4 x 40 mg capsules) once daily Other Name: XTANDI Drug: abiraterone acetate 1,000 mg (4 x 250 mg tablets) once daily Other Name: ZYTIGA Drug: Prednisone 5mg(5mg x 1 tablet) twice daily |
Contacts
Investigators
Principal Investigator
Fangjian Zhou
Sun Yat-Sen University Cancer Center
