Trial Outcomes & Findings for Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer (NCT NCT03570476)

NCT ID: NCT03570476

Last Updated: 2020-09-21

Results Overview

Percent of patients who achieve a pCR at the time of prostatectomy, after 12 weeks of neoadjuvant therapy with olaparib. PCR is defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen. Assessment will be based on the recommendations of the International Society of Urological Pathology (ISUP).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: At time of prostatectomy (at 12 weeks)
• Results posted on: 2020-09-21

Participant Flow

Participant milestones

Measure	Treatment (Olaparib, Radical Prostatectomy) Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer

Baseline characteristics by cohort

Measure	Treatment (Olaparib, Radical Prostatectomy) n=2 Participants Participants receive olaparib PO BID for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery
Age, Continuous	57 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	2 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	2 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
Region of Enrollment United States	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: At time of prostatectomy (at 12 weeks)

Percent of patients who achieve a pCR at the time of prostatectomy, after 12 weeks of neoadjuvant therapy with olaparib. PCR is defined as the absence of morphologically identifiable carcinoma in the prostatectomy specimen. Assessment will be based on the recommendations of the International Society of Urological Pathology (ISUP).

Outcome measures

Measure	Treatment (Olaparib, Radical Prostatectomy) n=2 Participants Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery
Pathologic Complete Response (pCR) Rate	0 Participants

PRIMARY outcome

Timeframe: Up to 30 days after the last dose of olaparib

Will be evaluated according to Common Terminology Criteria for Adverse Events (CTCAE).

Outcome measures

Measure	Treatment (Olaparib, Radical Prostatectomy) n=2 Participants Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery
Number of Participants With Adverse Events	0 Participants

SECONDARY outcome

Timeframe: At time of prostatectomy (at 12 weeks)

The rate of detectable tumor in pathology specimens obtained at prostatectomy.

Outcome measures

Measure	Treatment (Olaparib, Radical Prostatectomy) n=2 Participants Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery
Rate of Positive Surgical Margins	0 Participants

SECONDARY outcome

Timeframe: At time of prostatectomy (at 12 weeks)

Pathology specimens obtained at prostatectomy will be assessed using the tumor, lymph node, and metastasis (TNM) staging system for prostate cancer.

Stage Stage 2 represents patients with disease without evidence of extension outside of the prostate Stage 3 represents patients with disease which has penetrated the capsule of the prostate

Outcome measures

Measure	Treatment (Olaparib, Radical Prostatectomy) n=2 Participants Participants receive olaparib orally twice daily for 90 days in the absence of unacceptable toxicity. Beginning 1 day after last olaparib dose, participants undergo radical prostatectomy. Olaparib: Given PO Radical Prostatectomy: Undergo surgery
Stage of Disease Stage 2	0 Participants
Stage of Disease Stage 3	2 Participants

Adverse Events

Treatment (Olaparib, Radical Prostatectomy)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bruce Montgomery, PI

University of Washington

Phone: 206-598-0860

Email: rbmontgo@uw.edu

Results disclosure agreements

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