Pembrolizumab With Androgen Deprivation Therapy and Radiotherapy for the Treatment of Patients With High Risk Localized Prostate Cancer

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT06528210
Phase
PHASE2
Status
Withdrawn

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

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Gonadotropin Releasing Hormone Agonists and Antagonists — DRUG
    Given PO, IM, Sub-Q injection or Sub-Q implant
  • Bicalutamide — DRUG
    Given PO
  • Biopsy Procedure — PROCEDURE
    Undergo prostate biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Computed Tomography — PROCEDURE
    Undergo CT scan
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Questionnaire Administration — OTHER
    Ancillary study
  • Radiation Therapy — RADIATION
    Undergo radiation therapy
  • Bone Scan — PROCEDURE
    Undergo bone scan

Study Details

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.

Key Dates

Start date
Apr 16, 2025
Status verified
Sep 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2028

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (Pembrolizumab, ADT, radiotherapy)
    Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 3 weeks for 51 weeks in the absence of disease progression or unacceptable toxicity. Patients receive standard of care ADT with GNRH agonist (leuprolide, goserelin, triptorelin) or GNRH antagonist (relugolix, degarelix) for a total of 24 months, bicalutamide PO QD for 6 months or up to 24 months per the discretion of the treating physician and radiation therapy per standard of care. Treatment is given in the absence of disease progression or unacceptable toxicity. Patients undergo bone scan and/or CT scan/MRI during screening and prostate biopsy and blood sample collection throughout the study.

Primary Outcome Measure

Biopsy-complete response determined by post-treatment biopsy [ Time Frame: From first dose of pembrolizumab Cycle 1 Day 1 to 6 months after Cycle 1 Day 1. Cycle length is 21 days. ]

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