Study on Combining Low Dose Radiation, Pembrolizumab, and Surgery for Men with Intermediate/High Risk Prostate Cancer (TALON)

Sponsor: Duke University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04569461

Provider View

This clinical trial is exploring a new treatment approach for men with intermediate or high-risk prostate cancer. The study involves using a combination of low dose radiation, the drug pembrolizumab, and surgery to see if it can better control the cancer.

Patient Parameters

Program Overview

The study aims to test a new treatment method for men with prostate cancer that is considered intermediate or high risk. Participants will receive a combination of pembrolizumab, a type of immunotherapy, along with targeted radiation therapy to the prostate and short-term hormone therapy. After this treatment, they will undergo surgery to remove the prostate. Researchers will analyze the removed prostate tissue to look for changes and will monitor participants for two years to see if the cancer returns, as indicated by prostate-specific antigen (PSA) levels. The results will be compared to past data to determine if this approach delays the return of cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be able to understand and sign a consent form.
  • Age 18 or older.
  • Diagnosed with prostate cancer and eligible for prostate removal surgery. Certain types of prostate cancer are allowed, but not small cell carcinoma.
  • Must have at least two intermediate risk factors or be classified as high or very high risk according to specific medical guidelines.
  • Must be in good general health with a performance status score of 0 or 1.
  • Must have a prostate symptom score of less than 18 within 28 days before starting treatment.
  • Must have normal organ and bone marrow function based on specific blood test results.
  • Must be willing to follow the study protocol, including attending all treatments and follow-up visits.

Exclusion Criteria

  • History of cancer spread to bones, brain, or other organs.
  • Previous radiation or certain treatments to the prostate.
  • Previous treatment with specific immune therapies.
  • Participation in another study with an investigational drug within the last 4 weeks.
  • Previous treatment for prostate cancer, with some exceptions.
  • Current use of certain cancer treatments.
  • Active autoimmune disease requiring treatment in the past 2 years.
  • Need for chronic steroid or immunosuppressive drug use, with some exceptions.
  • Uncontrolled health conditions that could interfere with the study.
  • History of another cancer, with some exceptions.
  • History of stem cell transplant or immune deficiency.
  • Known HIV or active hepatitis B or C infection.
  • Recent receipt of a live vaccine.
  • History of lung inflammation requiring steroids.
  • Any condition that the study doctor believes would prevent participation.

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