Trial Outcomes & Findings for Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis (NCT NCT03047135)

NCT ID: NCT03047135

Last Updated: 2025-06-17

Results Overview

Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value, confirmed with a second measurement at least 4 weeks apart.

• Recruitment status: ACTIVE_NOT_RECRUITING
• Study phase: PHASE2
• Target enrollment: 51 participants
• Primary outcome timeframe: 6 years 2 months
• Results posted on: 2025-06-17

Participant Flow

Participant milestones

Measure	Olaparib 300 mg BID Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. Olaparib: Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Overall Study STARTED	51
Overall Study COMPLETED	48
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Olaparib 300 mg BID Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. Olaparib: Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Overall Study Still being treated	3

Baseline Characteristics

Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis

Baseline characteristics by cohort

Measure	Olaparib 300 mg BID n=51 Participants Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. Olaparib: Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants
Age, Categorical >=65 years	31 Participants n=5 Participants
Age, Continuous	63.8 Years STANDARD_DEVIATION 6.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	47 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	51 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 years 2 months

Number of participants with PSA50 response defined as at least a 50% decline in Prostate Specific Antigen (PSA) from baseline value, confirmed with a second measurement at least 4 weeks apart.

Outcome measures

Measure

Olaparib 300 mg BID n=51 Participants Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. Olaparib: Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.

PSA50 Response Rate to Olaparib for Patients With High-risk Biochemically-recurrent Prostate Cancer

13 Participants

SECONDARY outcome

Timeframe: Baseline to End of Treatment

Number of participants with treatment related adverse events

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 years

Defined as a time from initiation on olaparib therapy until PSA increase of 25%, confirmed with another measurement at least 4 weeks later.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 years

Number of patients on study with olaparib who achieves a PSA < 0.1, which is confirmed with a repeat measurement at least 12 weeks later.

Outcome measures

Outcome data not reported

Adverse Events

Olaparib 300 mg BID

Serious events: 2 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Measure	Olaparib 300 mg BID n=51 participants at risk Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. Olaparib: Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Blood and lymphatic system disorders Anemia	2.0% 1/51 • Number of events 1 • Baseline to End of Treatment approximately 6 years 2 months
Cardiac disorders Cerebrovascular Accident	2.0% 1/51 • Number of events 1 • Baseline to End of Treatment approximately 6 years 2 months

Other adverse events

Measure	Olaparib 300 mg BID n=51 participants at risk Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water. Olaparib: Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
Gastrointestinal disorders Nausea	54.9% 28/51 • Number of events 28 • Baseline to End of Treatment approximately 6 years 2 months
Blood and lymphatic system disorders Leukopenia	39.2% 20/51 • Number of events 20 • Baseline to End of Treatment approximately 6 years 2 months
General disorders Fatigue	68.6% 35/51 • Number of events 35 • Baseline to End of Treatment approximately 6 years 2 months
Respiratory, thoracic and mediastinal disorders Cough	19.6% 10/51 • Number of events 10 • Baseline to End of Treatment approximately 6 years 2 months
Metabolism and nutrition disorders Anorexia	19.6% 10/51 • Number of events 10 • Baseline to End of Treatment approximately 6 years 2 months
Nervous system disorders Headache	25.5% 13/51 • Number of events 13 • Baseline to End of Treatment approximately 6 years 2 months
Nervous system disorders Dizziness	7.8% 4/51 • Number of events 4 • Baseline to End of Treatment approximately 6 years 2 months
Gastrointestinal disorders Vomiting	15.7% 8/51 • Number of events 8 • Baseline to End of Treatment approximately 6 years 2 months
Blood and lymphatic system disorders Thrombocytopenia	17.6% 9/51 • Number of events 9 • Baseline to End of Treatment approximately 6 years 2 months
Blood and lymphatic system disorders Anemia	37.3% 19/51 • Number of events 19 • Baseline to End of Treatment approximately 6 years 2 months
Respiratory, thoracic and mediastinal disorders Dyspnea	17.6% 9/51 • Number of events 9 • Baseline to End of Treatment approximately 6 years 2 months
Nervous system disorders Dysgeusia	27.5% 14/51 • Number of events 14 • Baseline to End of Treatment approximately 6 years 2 months
Gastrointestinal disorders Diarrhea	15.7% 8/51 • Number of events 8 • Baseline to End of Treatment approximately 6 years 2 months
General disorders Edema	9.8% 5/51 • Number of events 5 • Baseline to End of Treatment approximately 6 years 2 months
Gastrointestinal disorders Constipation	9.8% 5/51 • Number of events 5 • Baseline to End of Treatment approximately 6 years 2 months
Gastrointestinal disorders Abdominal Pain	7.8% 4/51 • Number of events 4 • Baseline to End of Treatment approximately 6 years 2 months
Gastrointestinal disorders Dyspepsia	11.8% 6/51 • Number of events 6 • Baseline to End of Treatment approximately 6 years 2 months
Musculoskeletal and connective tissue disorders Pain-Back	5.9% 3/51 • Number of events 3 • Baseline to End of Treatment approximately 6 years 2 months
Blood and lymphatic system disorders Alanine Aminotransferase-Increased	9.8% 5/51 • Number of events 5 • Baseline to End of Treatment approximately 6 years 2 months
Blood and lymphatic system disorders Aspartate Aminotransferase-increased	5.9% 3/51 • Number of events 3 • Baseline to End of Treatment approximately 6 years 2 months
Gastrointestinal disorders Dry Mouth	5.9% 3/51 • Number of events 3 • Baseline to End of Treatment approximately 6 years 2 months

Additional Information

Catherine Handy Marshall, MD

Johns Hopkins University

Phone: 410-955-0231

Email: chm@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place