A Phase 2 Study of Neoadjuvant PARP Inhibition followed by Radical Prostatectomy in Patientswith Unfavorable Intermediate-Risk or High-Risk Prostate Cancer with BRCA1/2 GeneAlterations (NePtune)

Contact:

NCT Number:

Protocol:

AAAV1007

Study Status:

Active/Enrolling

Population:

Adult

Phase:

II

This is a research study to find out if giving a drug called olaparib with a Luteinizing hormone- releasing hormone (LHRH) agonist (medication that suppresses testosterone) before you undergo a radical prostatectomy (surgery to remove your prostate) decreases the amount of cancer present at the time of surgery and decrease the risk of the disease coming back after surgery. You will receive one of the LHRH agonist: leuprolide, triptorelin or goserelin. Olaparib, leuprolide, triptorelin and goserelin is FDA approved for several types of cancers such as certain types of ovarian, breast, pancreatic and prostate cancer, but they are not being used in accordance with their FDA approval in this study.

Are you Eligible? (Inclusion Criteria)

  • 18 years of age or older -Diagnosis of stage 1-3 prostatic adenocarcinoma -Must have evidence of germline or somatic BRCA1/2 gene alteration -No evidence of disease that has spread -Participants must be candidates for radical prostatectomy (RP) in which the prostate gland and some tissue around the gland will be removed

Specialty Area(s)

Prostate Cancer

Principal Investigator

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032