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: 2026-05-12
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
2026-05-12
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=1512 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=1512 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=1512 Participants
|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 6.8 • n=1512 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=1512 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1512 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=1512 Participants
|
|
Region of Enrollment
United States
|
51 Participants
n=1512 Participants
|
PRIMARY outcome
Timeframe: 6 years 2 monthsNumber 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 TreatmentNumber of participants with treatment related adverse events
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 yearsDefined 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 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 7 yearsNumber 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place