Study of Neoadjuvant PARP Inhibition Followed by Radical Prostatectomy in Patients With Unfavorable Intermediate-Risk or High-Risk Prostate Cancer With Select HRR Gene Alterations

Part of paid clinical trials in La Jolla, California.

Sponsor
Rana McKay, MD
Study ID
NCT05498272
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • BRCA1 Mutation
  • BRCA2 Mutation
  • High-Risk Cancer
  • Prostate Cancer
  • Prostatic Adenocarcinoma

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    300 mg orally twice a day (D1-D30) for 6 Cycles (30 day Cycles)
  • LHRH agonist — DRUG
    Total duration of therapy will be for 180 days with use of agent as per institutional standards

Study Details

Phase 2 open-label, single-arm clinical trial evaluating the efficacy and safety of neoadjuvant olaparib + LHRH agonist administered for 6 months prior to radical prostatectomy (RP) in men with unfavorable intermediate-risk or high-risk localized prostate cancer. All patients must have confirmed germline or somatic select HRR alterations. Germline and somatic mutation testing will be performed as part of commercially available CLIA assays and will be validated on a uniform platform centrally all patients retrospectively. Eligible patients will receive treatment with olaparib + LHRH agonist. Following 6 months of therapy, patients will undergo RP with mandatory lymph node dissection. The lymph node dissection template will be at the discretion of the treating urologist. RP specimens will undergo pathology blinded independent central review. Following RP, patients will be followed for testosterone recovery and PSA progression.

Key Dates

First listed
Aug 12, 2022
Start date
Feb 1, 2023
Status verified
Jul 2026
Primary completion
Aug 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Investigational Group
    300 mg of olaparib taken orally twice a day for 6 cycles (approximately 6 months). There are 30 days in a cycle. Olaparib will be taken with an LHRH agonist (leuprolide, triptorelin, or goserlin). This choice of therapy will be taken for a total of 180 days per institutional standards. After 6 cycles of neoadjuvant therapy, patients will undergo a radical prostatectomy (RP). After RP, patients will be followed for testosterone recovery and PSA progression.

Primary Outcome Measure

Pathological Complete Response (pCR) rate [ Time Frame: 4 years ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of California San Diego - Moores Cancer CenterLa JollaCalifornia92093-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21287-
Columbia University Irving Medical CenterNew YorkNew York10032-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
University of CincinnatiCincinnatiOhio45229-
Penn Medicine Abramson Cancer CenterPhiladelphiaPennsylvania19104-

Find similar trials in La Jolla, CA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of California San Diego - Moores Cancer Center· La Jolla, CAJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MDColumbia University Irving Medical Center· New York, NYMemorial Sloan Kettering Cancer Center· New York, NYUniversity of Cincinnati· Cincinnati, OHPenn Medicine Abramson Cancer Center· Philadelphia, PA

Related Studies