Study Comparing Hormone Therapy and Radiation vs. Radiation Alone for Unfavorable Intermediate Risk Prostate Cancer

Sponsor: NYU Langone Health

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06397703

Provider View

This clinical trial is exploring whether adding hormone therapy to radiation treatment is more effective than radiation alone for patients with unfavorable intermediate risk prostate cancer. Participants will be monitored every 6 months for up to 5 years, with a follow-up biopsy to check for cancer control.

Patient Parameters

Program Overview

The study aims to determine if combining hormone therapy (Androgen Deprivation Therapy or ADT) with a type of precise radiation treatment called stereotactic body radiation therapy (SBRT) is more effective than using SBRT alone in treating prostate cancer that is considered unfavorable intermediate risk. Patients will be randomly assigned to one of the two treatment groups and will be followed up every 6 months for up to 5 years. A routine biopsy will be performed 24-30 months after the radiation treatment to assess how well the cancer is being controlled.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with unfavorable intermediate risk prostate cancer, which includes:
    • Gleason score of 4+3
    • More than 50% of biopsy samples showing Gleason 7 cancer
    • Two or three intermediate risk factors (Gleason 7, PSA 10-20 ng/mL, or stage T2b-T2c)
  • Must have tissue available for specific genetic testing (Decipher score) before starting the study
  • Testosterone levels of at least 150 ng/dL within 2 months before joining the study
  • At least 4 weeks since any major surgery
  • General health status score of 80% or higher (Karnofsky Performance Scale)
  • Prostate size less than 90 cc as measured by MRI or CT scan
  • Urinary symptom score (IPSS) of 20 or less
  • Must be available for follow-up visits, with phone and chart reviews allowed after 2 years
  • Adequate liver function with specific blood test results
  • Adequate kidney function with specific blood test results
  • Adequate blood cell counts, including neutrophils, platelets, and hemoglobin levels

Exclusion Criteria

  • Evidence of cancer spread to the bones on scans
  • Suspicious lymph nodes on scans
  • Previous treatment for prostate cancer, including recent chemotherapy, hormone therapy, or surgery (except for certain prostate procedures like TURP or PVP)
  • History of another cancer within the last 2 years, except for certain skin cancers or cancers in complete remission
  • History of Crohn's disease or ulcerative colitis

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