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
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)
1 other identifier
interventional
43
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jul 2022
Longer than P75 for phase_4
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedStudy Start
First participant enrolled
July 29, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 22, 2024
CompletedResults Posted
Study results publicly available
December 19, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
ExpectedApril 21, 2026
March 1, 2026
2.2 years
July 11, 2022
October 22, 2025
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)
rPFS is defined as the time from randomization until the date of objective disease progression (soft tissue or bone) or death (by any cause in the absence of progression) regardless of whether the patient withdraws from randomized therapy or receives another anti-cancer therapy prior to progression.
Tumor assessments every 8 weeks (± 1 week) relative to the date of randomization until radiological progression as assessed by BICR or death (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).
Secondary Outcomes (8)
Confirmed Objective Response Rate (ORR), Based on Blinded Independent Review (BICR)
Tumor assessments every 8 weeks (± 1 week) from randomisation until radiographic progression assessed by BICR (median duration of treatment of 9 and 6 months for Olaparib and Investigators Choice of NHA respectively).
Overall Survival
From the time from the date of randomization until death due to any cause. Assessments continue up to 27 months after the first patient was randomized.
Time to First Symptomatic Skeletal-related Event
Time from randomization to the first SSRE-radiation for skeletal symptoms, confirmed pathological fracture, confirmed spinal cord compression, or orthopaedic surgery for bone metastases. Assessments continue up to 27 months post first patient enrolled.
Time to Opiate Use for Cancer-related Pain
Opioid use will be recorded at baseline and at every study visit, including the safety follow-up visit. Assessments continue up to 27 months post first patient enrolled.
Prostate-specific Antigen Response
Blood samples for PSA assessment will be collected at baseline and every 4 weeks throughout the treatment phase, including at the study treatment discontinuation visit. Assessments continue up to 27 months post first patient enrolled.
- +3 more secondary outcomes
Study Arms (2)
Olaparib
EXPERIMENTALOlaparib 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
Enzalutamide OR abiraterone acetate
ACTIVE COMPARATOREnzalutamide: 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.
Interventions
160 mg (4 x 40 mg capsules) once daily
1,000 mg (4 x 250 mg tablets) once daily
Eligibility Criteria
You may qualify if:
- 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.
- Radiological progression at study entry while on androgen deprivation therapy (or after bilateral orchiectomy).
- Deleterious or suspected deleterious BRCA1/2 mutation in tumor tissue.
- Normal organ and bone marrow function measured within 28 days prior to administration of study treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing.
You may not qualify if:
- Any previous treatment with a poly (adenosine diphosphate \[ADP\] ribose) polymerase (PARP) inhibitor, including olaparib.
- Subjects who had any previous treatment with DNA-damaging cytotoxic chemotherapy, except if for non-prostate cancer indication and last dose \> 5 years prior to randomization.
- History of another primary malignancy except for malignancy treated with curative intent with no known active disease for ≥5 years before the first dose of study intervention and of low potential risk for recurrence.
- Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Myriad Genetics, Inc.collaborator
- AstraZenecalead
- Merck Sharp & Dohme LLCcollaborator
- Foundation Medicinecollaborator
Study Sites (35)
Research Site
Beijing, 100050, China
Research Site
Bengbu, 233004, China
Research Site
Changsha, 410008, China
Research Site
Changsha, 410013, China
Research Site
Chengdu, 610000, China
Research Site
Chongqing, 408099, China
Research Site
Fuzhou, 350005, China
Research Site
Guangzhou, 510060, China
Research Site
Guangzhou, 510180, China
Research Site
Hangzhou, 310003, China
Research Site
Hangzhou, 310009, China
Research Site
Hangzhou, 310014, China
Research Site
Hefei, 230601, China
Research Site
Jiaxing, 314001, China
Research Site
Jinan, 250012, China
Research Site
Jinan, 250021, China
Research Site
Jining, 272029, China
Research Site
Kunming, 650101, China
Research Site
Lanzhou, 730030, China
Research Site
Linyi, 276000, China
Research Site
Nanchang, 330006, China
Research Site
Nantong, 226361, China
Research Site
Ningbo, 315010, China
Research Site
Shanghai, 200002, China
Research Site
Shanghai, 200032, China
Research Site
Shenyang, 110004, China
Research Site
Suzhou, 215004, China
Research Site
Taiyuan, 030000, China
Research Site
Tianjin, 300060, China
Research Site
Wanzhou, 404000, China
Research Site
Wuhan, 430022, China
Research Site
Wuxi, 214002, China
Research Site
Wuxi, 214023, China
Research Site
Xi'an, 710077, China
Research Site
Zhengzhou, 450052, China
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Lead
- Organization
- AstraZeneca Clinical Study Information Center
Study Officials
- PRINCIPAL INVESTIGATOR
Fangjian Zhou, M.D.
Sun Yat-Sen University Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2022
First Posted
July 13, 2022
Study Start
July 29, 2022
Primary Completion
October 22, 2024
Study Completion (Estimated)
December 31, 2026
Last Updated
April 21, 2026
Results First Posted
December 19, 2025
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
- Access Criteria
- When a request has been approved, AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access.For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment（https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure). "Yes" indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.