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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation, Biological
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• Male participants with histologically confirmed adenocarcinoma of the prostate

• High-risk / very high-risk status per NCCN guidelines

• ECOG performance status 0 to 1

• Regional lymph nodes are allowed.

• Agree to use contraception during the treatment period and for at least 120 days after the last dose of study intervention and refrain from donating sperm during this period.

• Ability to understand and the willingness to sign a written informed consent document.

• Adequate organ and marrow function

• Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is ≤90 days prior to the date of registration

• Prior 5-alpha reductase inhibitor (for example, finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to registration.

• Known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Utah
Huntsman Cancer Institute
RECRUITING
Salt Lake City
Contact Information
Primary
Bryan Courtney
bryancourtney@uky.edu
859-257-3379
Time Frame
Start Date: 2023-07-27
Estimated Completion Date: 2029-07-02
Participants
Target number of participants: 64
Treatments
Experimental: Arm 1 - Pembrolizumab and Olaparib
Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab and Olaparib.
Experimental: Arm 2 - Pembrolizumab
Patients with high-risk prostate cancer receiving combination therapy with Pembrolizumab.
Related Therapeutic Areas
Sponsors
Collaborators: Merck Sharp & Dohme LLC
Leads: Zin W Myint

This content was sourced from clinicaltrials.gov