Trial Outcomes & Findings for BrUOG 337: Olaparib Prior to Radical Prostatectomy For Advanced Prostate Cancer Defects in DNA Repair Genes (NCT NCT03432897)

Last Updated: 2025-07-08

Results Overview

Response:Reduction of at least 50% in the prostate-specific antigen level from baseline Progression:A 25% increase in PSA from baseline Baseline then approximately 8 weeks later and 2 weeks post Olaparib, approximately 10-14 weeks after baseline and then approximately every 6 months for 2 years in follow-up.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

1 participants

Primary outcome timeframe

Throughout the trial for approximately 2 years

Results posted on

2025-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2. Between 22-42 days post Olaparib, patients will undergo a prostatectomy. Olaparib Pill: 300 mg BID Prostatectomy: 22-42 days post Olaparib patients will undergo surgery
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BrUOG 337: Olaparib Prior to Radical Prostatectomy For Advanced Prostate Cancer Defects in DNA Repair Genes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=1 Participants Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2. Between 22-42 days post Olaparib, patients will undergo a prostatectomy. Olaparib Pill: 300 mg BID Prostatectomy: 22-42 days post Olaparib patients will undergo surgery
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	69 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants

PRIMARY outcome

Timeframe: Throughout the trial for approximately 2 years

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2. Between 22-42 days post Olaparib, patients will undergo a prostatectomy. Olaparib Pill: 300 mg BID Prostatectomy: 22-42 days post Olaparib patients will undergo surgery
Number of Participants With Prostate Specific Antigen (PSA) Response	0 Participants

SECONDARY outcome

Timeframe: Post treatment (approximately 8-12 weeks) and approximately every 6 months for 2 years.

Evaluation by treating physician

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2. Between 22-42 days post Olaparib, patients will undergo a prostatectomy. Olaparib Pill: 300 mg BID Prostatectomy: 22-42 days post Olaparib patients will undergo surgery
PSA Progression-free Survival of Olaparib and Radical Prostatectomy for Patients With Locally Advanced Prostate Cancer and Defects in DNA Repair Genes.	7 months

SECONDARY outcome

Timeframe: Eight to 12 weeks prior to radical prostatectomy utilizing the descriptions and grading scales found in the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for grading all adverse events.

Outcome measures

Outcome measures
Measure	Treatment n=1 Participants Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2. Between 22-42 days post Olaparib, patients will undergo a prostatectomy. Olaparib Pill: 300 mg BID Prostatectomy: 22-42 days post Olaparib patients will undergo surgery
Safety of Olaparib Prior to Radical Prostatectomy for Patients With Locally Advanced Prostate Cancer	1 Participants

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Treatment n=1 participants at risk Olaparib 300 mg BID q 4 weeks for up to 3 cycles. The 3rd cycle will not be given if patient is found to progress post cycle 2. Between 22-42 days post Olaparib, patients will undergo a prostatectomy. Olaparib Pill: 300 mg BID Prostatectomy: 22-42 days post Olaparib patients will undergo surgery
Nervous system disorders Dysgeusia	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Infections and infestations Bronchial infection	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
General disorders Localized edema	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
General disorders Edema limbs	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
General disorders Malaise	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Respiratory, thoracic and mediastinal disorders Postnasal drip	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Respiratory, thoracic and mediastinal disorders Cough	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Investigations Creatinine increased	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Musculoskeletal and connective tissue disorders Arthralgia	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Blood and lymphatic system disorders Anemia	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Metabolism and nutrition disorders Anorexia	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
General disorders Fatigue	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.
Renal and urinary disorders Urinary incontinence	100.0% 1/1 • From time of informed consent and until 4 weeks (30 days (+7 days)) after the patient has stopped study participation/treatment (olaparib or surgery, whatever is the last date of treatment), maximum of 20 weeks.

Additional Information

BrUOG

Brown Oncology Research Group

Phone: 4018633000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place