Pembro With Radiation With or Without Olaparib

• Status: Not yet recruiting
• Trial end date: 2028-01-02
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zin W Myint
• Collaborator: Merck Sharp & Dohme LLC
• Treatments: Androgens; Olaparib; Pembrolizumab

Criteria

Inclusion Criteria:

• Male participants with histologically confirmed adenocarcinoma of the prostate

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

• ECOG performance status 0 to 1

• No pelvic nodes >2 cm in long axis as established by CT imaging

• 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.

Exclusion Criteria:

• PSA > 150ng/ml

• Prior hormonal therapy with LHRH agonists (e.g., Lupron) and LHRH antagonists (e.g., Degarelix)for prostate cancer continuously for more than 90-days prior to study enrollment.

• Prior radiation to the prostate. Previous pelvic RT or major surgery (colorectal anastomosis, total cystectomy, radical prostatectomy, TURP, etc.). History of Ulcerative proctitis.

• Concurrent active, additional malignancy in the last 2 years.

• Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to randomization.

• Patients with distant metastases