drugset / Trial / NCT03432897

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

NCT03432897 ↗

NaSingle-groupOpen-labelTreatment

Summary

This study will evaluate approximately 3 months of treatment with the drug olaparib in patients with prostate cancer. A capsule formulation of olaparib (tradename Lynparza™) is approved by the United States Food and Drug Administration (FDA) for the treatment of women with advanced BRCA-mutated ovarian cancer. Olaparib is an investigational drug in prostate cancer. A tablet formulation of olaparib is being tested in this study. It is a new formulation which is more convenient for patients than the approved capsule formulation because fewer tablets of olaparib need to be taken daily than with capsules. The purpose of the study is to evaluate whether olaparib can reduce prostate cancer with defects in DNA repair genes when olaparib is given for approximately 3 months before surgery.

Timeline

Start
2018-05-25
Primary completion
2020-12-15
Completion
2021-12-07

Outcome

Outcome not reported

Stopped (Enrollment): “Lack of enrollment secondary to eligibility criteria”

Drugs

EvaluationDrugModalityDoseRoute
Subject Olaparib Small molecule 300 mg —