Trial Outcomes & Findings for 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 (NCT NCT05457257)

Last Updated: 2025-12-19

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

43 participants

Primary outcome timeframe

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).

Results posted on

2025-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Olaparib 300 mg bd Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Overall Study STARTED	29	14
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	29	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Olaparib 300 mg bd Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Overall Study Withdrawal by Subject	0	2
Overall Study Death	10	3
Overall Study Ongoing	19	9

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)	Total n=43 Participants Total of all reporting groups
Age, Continuous	68.0 Years n=8 Participants	67.5 Years n=6 Participants	68.0 Years n=6 Participants
Sex: Female, Male Female	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Sex: Female, Male Male	29 Participants n=8 Participants	14 Participants n=6 Participants	43 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=8 Participants	14 Participants n=6 Participants	43 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	29 Participants n=8 Participants	14 Participants n=6 Participants	43 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) White	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=8 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants

PRIMARY outcome

Timeframe: 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).

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Radiological Progression-free Survival - Based on Blinded Independent Central Review (BICR)	9.331 Months Interval 5.65 to 11.2	8.838 Months Interval 1.77 to NA - not calculated as an insufficient number of events for the upper limits of the 95% confidence interval

SECONDARY outcome

Timeframe: 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).

Population: Evaluable for response analysis set

Confirmed ORR is the percentage of patients with a Complete response (CR) or Partial response (PR), in their soft tissue disease per (RECIST v1.1), in the absence of progression on bone scan per Prostate Cancer Working Group 3 (PCWG3), confirmed \>=4 weeks later. Per RECIST v1.1, CR=Disappearance of all target lesions; PR = \>=30% decrease in the sum of diameters of target lesions. For each treatment group, confirmed ORR is the number of patients with a confirmed CR or PR divided by the number of patients in the treatment group.

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=12 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=5 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Confirmed Objective Response Rate (ORR), Based on Blinded Independent Review (BICR)	5 Participants	1 Participants

SECONDARY outcome

Timeframe: 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.

Population: Full analysis set

OS is the time from the date of randomization until death due to any cause.

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Overall Survival	17.314 Months Interval 13.9 to NA - not calculated as an insufficient number of events for the upper limits of the 95% confidence interval	NA Months Interval 10.32 to NA - Not calculated, estimate cannot be calculated as the median OS was not reached. Insufficient number of participants with events for median and upper limits of 95% confidence interval.

SECONDARY outcome

Timeframe: 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.

Population: Full analysis set

Time from first dose to the first symptomatic skeletal-related event

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Time to First Symptomatic Skeletal-related Event	NA Months NA - Not calculated, estimate cannot be calculated as the median SSRE was not reached. Insufficient number of participants with events for median and lower and upper limits of 95% confidence interval.	NA Months NA - Not calculated, estimate cannot be calculated as the median SSRE was not reached. Insufficient number of participants with events for median and lower and upper limits of 95% confidence interval.

SECONDARY outcome

Timeframe: 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.

Population: Full analysis set (Only includes patients who were not on opiates at baseline)

Time from randomization to opiate use for cancer-related pain

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=23 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=9 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Time to Opiate Use for Cancer-related Pain	NA Months Interval 11.2 to NA - Not calculated, estimate cannot be calculated as the median Opioid use free was not reached. Insufficient number of participants with Opioid use free for median and upper limits of 95% confidence interval.	17.281 Months Interval 1.31 to NA - Not calculated as an insufficient number of participants with Opioid use free for upper limits of 95% confidence interval.

SECONDARY outcome

Timeframe: 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.

Population: Full analysis set

Proportion of participants achieving a ≥50% decrease in PSA from baseline to the lowest post-baseline PSA result, confirmed by a second consecutive PSA assessment at least 3 weeks later (PSA50 response)

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Prostate-specific Antigen Response Confirmed response	41 Percentage of participants Interval 24.0 to 61.0	29 Percentage of participants Interval 8.0 to 58.0
Prostate-specific Antigen Response Single visit response	48 Percentage of participants Interval 29.0 to 67.0	36 Percentage of participants Interval 13.0 to 65.0

SECONDARY outcome

Population: Full Analysis Set (Only includes patients have baseline PSA and post-baseline PSA results for analysis of "Best percentage change from baseline" and includes patients have baseline PSA and week 12 PSA for analysis of "Percentage change from baseline at Week 12" )

Best percentage change from baseline in PSA is defined as the biggest reduction in PSA level compared with baseline (or the smallest increase in the absence of a reduction) taking account of all PSA values collected for each patient.

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Prostate-specific Antigen Response Percentage change from baseline at Week 12	37.2 Percentage change from baseline Standard Deviation 252.62	-15.0 Percentage change from baseline Standard Deviation 53.84
Prostate-specific Antigen Response Best percentage change from baseline	-40.6 Percentage change from baseline Standard Deviation 60.06	-22.7 Percentage change from baseline Standard Deviation 74.62

SECONDARY outcome

Timeframe: Tumor assessments will be performed every 8 weeks (±7 days) after randomization until radiologic progression or death, unless the participant withdraws consent. Assessments continue up to 27 months post first patient enrolled.

Population: Full analysis set

Time from randomization to second progression by investigator assessment of radiological or clinical progression or death (PFS2)

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Time From Randomization to Second Progression or Death	NA Months Interval 15.41 to NA - Not calculated, estimate cannot be calculated as the median PFS2 was not reached. Insufficient number of participants with events for median and upper limits of 95% confidence interval.	NA Months Interval 5.91 to NA - Not calculated, estimate cannot be calculated as the median PFS2 was not reached. Insufficient number of participants with events for median and upper limits of 95% confidence interval.

SECONDARY outcome

Timeframe: Recorded from post discontinuation of study treatment up to primary data cut off date. Assessments continue up to 27 months post first patient enrolled.

Population: Full analysis set

Outcome measures

Outcome measures
Measure	Olaparib 300 mg bd n=29 Participants Participants will receive olaparib 300 mg oral tablets, twice daily	Investigators Choice of NHA n=14 Participants Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
Subsequent Anticancer Therapy Any post-discontinuation anti-cancer therapy	14 Participants	3 Participants
Subsequent Anticancer Therapy Immunotherapy	0 Participants	0 Participants
Subsequent Anticancer Therapy Hormonal therapy	12 Participants	2 Participants
Subsequent Anticancer Therapy Taxane chemotherapy	4 Participants	0 Participants
Subsequent Anticancer Therapy Platinum chemotherapy	0 Participants	0 Participants
Subsequent Anticancer Therapy PARP inhibitor	0 Participants	3 Participants
Subsequent Anticancer Therapy Other	1 Participants	0 Participants

Adverse Events

Olaparib 300mg bd

Serious events: 13 serious events

Other events: 28 other events

Deaths: 10 deaths

Investigators Choice of NHA

Serious events: 5 serious events

Other events: 13 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

Global Clinical Lead

AstraZeneca Clinical Study Information Center

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Olaparib 300mg bd n=29 participants at risk Description (Arm-group)	Investigators Choice of NHA n=14 participants at risk Participants will receive either enzalutamide 160 mg oral capsules/tablets once daily or abiraterone acetate 1000 mg oral tablets (plus prednisone 5 mg oral tablets twice daily)
General disorders Fatigue	3.4% 1/29 • Number of events 2 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Gastrointestinal disorders Vomiting	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Blood and lymphatic system disorders Anaemia	13.8% 4/29 • Number of events 5 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Infections and infestations Osteomyelitis	0.00% 0/29 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	7.1% 1/14 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Infections and infestations Pneumonia	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Infections and infestations Urinary tract infection	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Blood and lymphatic system disorders Leukopenia	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Investigations Blood creatinine increased	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Investigations Neutrophil count decreased	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Metabolism and nutrition disorders Decreased appetite	10.3% 3/29 • Number of events 4 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	7.1% 1/14 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Blood and lymphatic system disorders Thrombocytopenia	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Musculoskeletal and connective tissue disorders Back pain	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pituitary tumour benign	0.00% 0/29 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	7.1% 1/14 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Psychiatric disorders Completed suicide	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Renal and urinary disorders Dysuria	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Renal and urinary disorders Haematuria	0.00% 0/29 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	7.1% 1/14 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Renal and urinary disorders Urinary retention	0.00% 0/29 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	7.1% 1/14 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Reproductive system and breast disorders Acquired hydrocele	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Cardiac disorders Atrial fibrillation	3.4% 1/29 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	0.00% 0/14 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Vascular disorders Deep vein thrombosis	0.00% 0/29 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	7.1% 1/14 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier
Cardiac disorders Cardiac failure	0.00% 0/29 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier	7.1% 1/14 • Number of events 1 • From the time of signature of the ICF, throughout the treatment period and until the 30-day follow-up period is completed or 27 months post first patient enrolled, whichever occurs earlier