NCT03570476

Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer

Open-Label, Pilot Study of Olaparib as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Washington · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies how well olaparib works in treating participants with prostate cancer that has not spread to other parts of the body (localized). Olaparib may stop the growth of tumor cells by interfering with the activity of a substance called PARP, which is inside cells. Giving olaparib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Detailed description

PRIMARY OBJECTIVE: I. To assess the pathological complete response rate following olaparib when administered as neoadjuvant therapy prior to prostatectomy in patients with localized prostate cancer containing homozygous or complementary deoxyribonucleic acid \[DNA\] repair deficiency. SECONDARY OBJECTIVE: I. To determine the rate of positive surgical margins, extracapsular extension, positive seminal vesicles and lymph nodes at the time of prostatectomy. OUTLINE: 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. After completion of study treatment, participants are followed up for 30 days.

Conditions

• Prostate Adenocarcinoma Without Neuroendocrine Differentiation
• Stage I Prostate Cancer AJCC v8
• Stage II Prostate Cancer AJCC v8
• Stage IIA Prostate Cancer AJCC v8
• Stage IIB Prostate Cancer AJCC v8
• Stage IIC Prostate Cancer AJCC v8

Interventions

Type	Name	Description
DRUG	Olaparib	Given orally
PROCEDURE	Radical Prostatectomy	Undergo surgery

Timeline

• Start date: 2018-09-11
• Primary completion: 2019-05-31
• Completion: 2019-07-03
• First posted: 2018-06-27
• Last updated: 2020-09-21
• Results posted: 2020-09-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study