Pembro With Radiation With or Without Olaparib

Launched by ZIN W MYINT · Oct 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a combination of treatments for men with high-risk localized prostate cancer. Researchers want to see if using an immunotherapy drug called Pembrolizumab along with radiation therapy is more effective when combined with another drug called Olaparib. The goal is to improve the immune system's response to cancer in these patients.

To participate, men must be diagnosed with prostate cancer and meet specific criteria, such as having a high-risk status and being in good overall health. Participants will receive the study treatments and will be monitored closely by the medical team to see how well the combination works. It's important for participants to understand that they need to agree to use contraception during the study and for a period afterward. Overall, this trial aims to find better treatment options for men facing this challenging diagnosis.

Gender

MALE

Eligibility 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
• • 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.
• 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 M1 disease