RecruitingPhase 2NCT05568550

Pembro With Radiation With or Without Olaparib

Phase II Study of Pembrolizumab in Combination With Radiation With or Without Olaparib in Localized High-risk Prostate Cancer


Sponsor

Zin W Myint

Enrollment

64 participants

Start Date

Jul 27, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

This trial will evaluate whether the immune-sensitizing effects of immunotherapy (Pembrolizumab) and radiation with or without a PARP-inhibitor (Olaparib) will increase the effects of immunotherapy in men with high-risk localized prostate cancer.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding pembrolizumab (an immunotherapy) and/or olaparib (a targeted PARP inhibitor) to standard radiation therapy improves outcomes for men with high-risk or very high-risk prostate cancer that has not yet spread beyond the region. The goal is to improve cure rates while comparing the different drug combinations. **You may be eligible if...** - You are a male with prostate cancer confirmed by biopsy - Your cancer is classified as high-risk or very high-risk by standard guidelines - Your cancer has not spread to distant organs (no M1 disease) - You are in good general health (ECOG 0 or 1) - Prior hormone therapy is allowed only if it started within 90 days before registering - Your organ function meets the required levels **You may NOT be eligible if...** - You have been on hormone-blocking therapy (LHRH agonists or antagonists) continuously for more than 90 days before enrollment - You have had prior radiation to the prostate or pelvis - You have had major prior pelvic surgery - You have ulcerative proctitis (inflammation of the rectum) - You have another active cancer - Your cancer has spread to distant sites (M1 disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALPembrolizumab

Pembrolizumab will be delivered via IV at 200mg on day 1 of each 3-week cycle for approximately 12 months. Cycle 1 begins 21 days prior to radiation therapy and cycles 2-17 are administered during and after radiation therapy.

DRUGOlaparib

200mg Olaparib will be given twice daily for a total of 3 cycles. Cycle 1 begins 21-days prior to radiation therapy.

DRUGAndrogen Deprivation Therapy

Androgen Deprivation Therapy (either LHRH agonist or LHRH antagonist) as per treating physician choice will be allowed within 3 months prior to randomization. Duration is per institutional standards.

RADIATIONRadiation Therapy

Definitive radiation (total dose and fractions) will be dosed per institutional standards. Definitive radiation may include external beam radiation therapy with or without brachytherapy, based on NCCN risk score and as per treating physicians.


Locations(2)

University of Kentucky

Lexington, Kentucky, United States

Huntsman Cancer Institute

Salt Lake City, Utah, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05568550


Related Trials