Study on Pembrolizumab with Hormone Therapy and Radiation for Treating High-Risk Localized Prostate Cancer

Sponsor: OHSU Knight Cancer Institute

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06528210

Provider View

This clinical trial is exploring how well the drug pembrolizumab works when combined with standard hormone therapy and radiation in treating patients with high-risk prostate cancer that hasn't spread beyond the prostate.

Patient Parameters

Program Overview

This study is testing a treatment plan for high-risk prostate cancer that hasn't spread to other parts of the body. The plan includes a drug called pembrolizumab, which helps the immune system fight cancer, along with hormone therapy to lower male hormones that help cancer grow, and radiation to kill cancer cells. The goal is to see if this combination can kill more cancer cells than the usual treatment alone.

Description

The main goals of this study are to see how many patients have no cancer cells in their prostate biopsy after 6 months of treatment with pembrolizumab, hormone therapy, and radiation, and to check the safety of this combination. Researchers will also look at how the treatment affects patients' quality of life and how long they stay cancer-free.

Patients will receive pembrolizumab through an IV every 3 weeks for about a year, along with hormone therapy and radiation. The hormone therapy includes drugs that lower testosterone, a hormone that can help prostate cancer grow. Patients will have regular scans and biopsies to monitor their progress.

After finishing the treatment, patients will have follow-up visits to check their health and see how well the treatment worked. The study will also explore how the treatment affects the immune system and look for any side effects.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with newly diagnosed high-risk prostate cancer that hasn't spread beyond the prostate.
  • Must have one of the following high-risk features: Gleason score over 8, PSA level over 20 ng/mL, or clinical stage T3a or T3b.
  • Must agree to use effective birth control during the study and for a period after the last treatment.
  • Must provide a tumor sample for analysis.
  • Must be in good overall health with specific blood counts and organ function within normal limits.
  • Must be willing to undergo prostate biopsies during the study.
  • Must not have a PSA level over 100 ng/mL unless it drops below this level without treatment.
  • Must be willing to complete quality of life questionnaires.
  • Must have controlled hepatitis B or C if previously infected.

Exclusion Criteria

  • Previous treatment with pembrolizumab or similar drugs.
  • Recent cancer treatments or radiation that required steroids.
  • Recent live vaccines.
  • Current use of immunosuppressive drugs or steroids.
  • Other active cancers or untreated brain metastases.
  • Severe allergies to pembrolizumab.
  • Active autoimmune diseases or lung diseases.
  • Active infections requiring treatment.
  • Known HIV infection.
  • Active hepatitis B or C infections.
  • Plans to use certain other cancer drugs during the study.
  • Large prostate size or previous prostate surgery.
  • Recent major surgery or ongoing complications from surgery.
  • Conditions that could interfere with the study or the patient's ability to participate.
  • Expecting to father a child during the study.

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