Study Comparing Two Boost Methods in Radiation Therapy for Prostate Cancer

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60

ClinicalTrials ID:NCT07548164

This clinical trial is exploring whether a new method called irreversible electroporation (IRE) is as effective as the standard radiation therapy boost for men with intermediate-risk prostate cancer undergoing stereotactic body radiotherapy (SBRT).

Patient Parameters

Program Overview

The purpose of this study is to determine if a new boost method, irreversible electroporation (IRE), is as effective as the traditional boost method used in radiation therapy for men with intermediate-risk prostate cancer. Participants will receive standard stereotactic body radiotherapy (SBRT) and will be randomly assigned to receive either the IRE boost or the standard radiation boost to see which approach works better.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with intermediate-risk prostate cancer, specifically grade group 2 or 3, with certain cancer patterns found only in MRI scans.
  • Prostate gland size must be 80 cc or smaller.
  • MRI results must show no advanced disease beyond a certain stage.
  • International Prostate Symptom Score (IPSS) must be less than 20.
  • No medical reasons preventing the use of IRE, radiation therapy, anesthesia, or the transperineal procedure.

Exclusion Criteria

  • Have a more advanced grade of prostate cancer or specific types of cancer cells.
  • Evidence of cancer spread to lymph nodes or other parts of the body on imaging tests.
  • Not suitable for general anesthesia or have allergies to necessary medications.
  • Have an active urinary tract infection that must be treated before the procedure.
  • Have bleeding issues or cannot safely stop blood thinners for the procedure.
  • Have a history of heart rhythm problems, epilepsy, or recent heart attack.
  • Have an implanted electronic device like a pacemaker that is not compatible with the procedure.
  • Cannot undergo an MRI scan of the pelvis.
  • Have had previous treatments for prostate cancer, such as hormone therapy, focal therapy, radiation, or surgery.
  • Currently using or planning to use hormone therapy for prostate cancer.

Locations

FACILITYZIPCITYSTATE
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)07920Basking RidgeNew Jersey
Memorial Sloan Kettering at Monmouth (Limited Protocol Activities)07748MiddletownNew Jersey
Memorial Sloan Kettering at Bergen (Limited Protocol Activities)07645MontvaleNew Jersey
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)11725CommackNew York
Memorial Sloan Kettering at Westchester (Limited Protocol Activities)10604HarrisonNew York
Weill Cornell Medical Center (Data Collection Only)10021New YorkNew York
Memorial Sloan Kettering Cancer Center (All Protocol Activites)10065New YorkNew York
Memorial Sloan Kettering at Nassau (Limited Protocol Activities)11553UniondaleNew York

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