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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT03432897
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib Pill — DRUG
    300 mg BID
  • Prostatectomy — PROCEDURE
    22-42 days post Olaparib patients will undergo surgery

Study Details

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.

Key Dates

Start date
May 25, 2018
Status verified
Jul 2025
Primary completion
Dec 15, 2020
Completion
Dec 7, 2021

Study Design

Enrollment
1 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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.

Primary Outcome Measure

Number of Participants With Prostate Specific Antigen (PSA) Response [ Time Frame: Throughout the trial for approximately 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lifespan Cancer Institute: The Miriam and Rhode Island HospitalsProvidenceRhode Island02903-

Find similar trials in Providence, RI

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Lifespan Cancer Institute: The Miriam and Rhode Island Hospitals· Providence, RI

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