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RECRUITING
NCT05568550
PHASE2

Pembro With Radiation With or Without Olaparib

Sponsor: Zin W Myint

View on ClinicalTrials.gov

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.

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

Key Details

Gender

MALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

64

Start Date

2023-07-27

Completion Date

2029-07-02

Last Updated

2026-01-30

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

Pembrolizumab

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.

DRUG

Olaparib

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

DRUG

Androgen 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.

RADIATION

Radiation 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