Study on MRI-guided High-dose Radiation Therapy for Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04997018

Provider View

This clinical trial is exploring whether a higher dose of radiation, targeted directly at the main tumor, can better treat intermediate-risk prostate cancer and prevent it from returning, while minimizing side effects.

Patient Parameters

Program Overview

This study is investigating a new approach to treating intermediate-risk prostate cancer using a type of radiation therapy called SBRT (stereotactic body radiation therapy). SBRT typically delivers high doses of radiation over fewer sessions. However, there is a 20% chance that the cancer may return after this treatment. The study aims to determine if giving an even higher dose of radiation directly to the main tumor, while providing the standard dose to the rest of the prostate, can cure the cancer or prevent it from coming back for a longer time with fewer side effects.

Eligibility Criteria

Inclusion Criteria

  • Have intermediate-risk prostate cancer, defined by:
    • PSA levels between 10-20 ng/ml
    • Gleason score of 7
    • Clinical stage T2b or T2c
  • Be 18 years or older
  • Have a Karnofsky Performance Status (KPS) of 80 or higher
  • Prostate size of 80 cc or less
  • Have a visible tumor on MRI that is at least 0.5 cm in size, with no more than one additional tumor site
  • MRI findings may show contact with the edge of the prostate capsule, and possible extension beyond the capsule is allowed
  • Have an International Prostate Symptom Score of 15 or less
  • Meet all MRI screening criteria and be willing to complete the MRI screening form

Exclusion Criteria

  • Gleason score greater than 7
  • PSA levels greater than 20
  • Previous or current hormone therapy for prostate cancer
  • MRI findings suggest more than two tumor sites
  • Evidence of cancer spread to bones or other areas on scans
  • Ineligibility for MRI due to devices like pacemakers, severe claustrophobia, or inability to lie flat
  • Metal implants in the pelvis that could affect MRI quality
  • Pelvic measurements incompatible with MRI requirements
  • Allergies to MRI contrast agents
  • KPS less than 80
  • MRI or CT evidence of advanced prostate cancer (T3, T4, or N1)
  • History of prostate surgery or urethral issues
  • Previous pelvic radiation
  • History of inflammatory bowel disease
  • Inability to give informed consent or complete quality of life surveys
  • Abnormal blood counts or kidney function tests

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