Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer
NCT Number: NCT06528210
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: High Risk Prostate Carcinoma|Localized Prostate Adenocarcinoma|Stage I Prostate Cancer AJCC v8|Stage II Prostate Cancer AJCC v8|Stage III Prostate Cancer AJCC v8
Interventions: DRUG: Gonadotropin Releasing Hormone Agonists and Antagonists|DRUG: Bicalutamide|PROCEDURE: Biopsy|PROCEDURE: Biospecimen Collection|PROCEDURE: Computed Tomography|PROCEDURE: Magnetic Resonance Imaging|BIOLOGICAL: Pembrolizumab|OTHER: Questionnaire Administration|RADIATION: Radiation Therapy|PROCEDURE: Bone Scan
Sponsor: OHSU Knight Cancer Institute
Collaborators: Merck Sharp & Dohme LLC|Oregon Health and Science University
Sex: MALE
Age: ADULT, OLDER_ADULT
Enrollment: 32
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2028-06-01
Locations: OHSU Knight Cancer Institute, Portland, Oregon, 97239, United States

Summary:
This phase II trial tests how well pembrolizumab along with standard of care androgen deprivation therapy, with bicalutamide and gonadotropin releasing hormone agonist, and radiotherapy for the treatment of patients with high risk prostate cancer that has not spread to other parts of the body (localized). A monoclonal antibody, such as pembrolizumab, is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Bicalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of tumor cells. Gonadotropin-releasing hormone agonists prevent the body from making luteinizing hormone-releasing hormone (LHRH) and luteinizing hormone (LH). This causes the testicles to stop making testosterone (a male hormone) in men and may stop the growth of prostate cancer cells that need testosterone to grow. Radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving pembrolizumab with androgen deprivation therapy and radiotherapy may kill more tumor cells in patients with high risk localized prostate cancer.

Primary Outcome Measures: Biopsy-complete response determined by post-treatment biopsy, Will be defined as absence of detectable malignant cells in cores evaluated by established histologic techniques. An exact one-sided confidence interval will also be estimated and provided., From first dose of pembrolizumab Cycle 1 Day 1 to 6 months after Cycle 1 Day 1. Cycle length is 21 days.|Incidence of adverse events, Using Common terminology Criteria for Adverse Events (CTCAE) version 5., From first dose of pembrolizumab to 30 days after last dose of pembrolizumab
Secondary Outcome Measures: Post-treatment cancer detection rates in tumors by levels of PD-1 and PD-L1 expression, Will be evaluated by pre-treatment prostate infiltrating T-cell PD-1 expression status based on the median split of the expression level. Exact 95% confidence intervals will also be estimated and provided., From first dose of pembrolizumab to 6 months after Cycle 1 Day 1. Cycle length is 21 days.|Health related quality of life, Will be summarized at each appropriate time point using number completed, mean, standard deviation, and 95% confidence intervals., From screening up to 5 years|Incidence of grade 3 or higher immune related adverse events, Using CTCAE version 5., From first dose of pembrolizumab to 30 days after last dose of pembrolizumab|Rate of biochemical relapse-free survival, Will be estimated using Kaplan-Meier method., From enrollment of trial to 30 days post last dose of pembrolizumab