Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study ID
NCT03047135
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Prostate

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.

Study Details

Olaparib has demonstrated preliminary efficacy in metastatic castration-resistant prostate cancer. In a trial of 49 evaluable patients treated with olaparib, 11 / 49 experienced a PSA response, and every patient with a radiographic response also had a PSA5 response. Ten of 11 responders had mutations in DNA repair genes. While PARP inhibition is showing promise in these initial studies, reserving its use for end-stage patients may not be the optimal timing for olaparib therapy in some patients. In addition, PARP enzymes function in roles beyond DNA repair, and specifically for prostate cancer are involved transcriptional regulation of the androgen receptor. PARP inhibition has not been tested in earlier disease states for prostate cancer.

Key Dates

Start date
Mar 1, 2017
Status verified
Apr 2026
Primary completion
May 24, 2023
Completion
May 1, 2027

Study Design

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

Arms

  • Experimental: Olaparib 300 mg BID
    Patients will be administered olaparib orally twice daily at 300mg bid continually. Two 150mg of olaparib tablets should be taken twice daily, approximately 12 hours apart with one glass of water.

Primary Outcome Measure

PSA50 Response Rate to Olaparib for Patients With High-risk Biochemically-recurrent Prostate Cancer [ Time Frame: 6 years 2 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Johns Hopkins HospitalBaltimoreMaryland21231-
University of Nebraska Medical CenterOmahaNebraska68198-
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
Allegheny Cancer CenterPittsburghPennsylvania15212-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins Hospital· Baltimore, MDUniversity of Nebraska Medical Center· Omaha, NEThomas Jefferson University· Philadelphia, PAAllegheny Cancer Center· Pittsburgh, PA

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