Study Comparing Two Different Schedules of MRI-Guided Radiation Therapy for Prostate Cancer

Sponsor: Weill Medical College of Cornell University

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT04984343

Provider View

This clinical trial is comparing two different schedules of radiation therapy, using MRI guidance, to treat men with low or intermediate-risk prostate cancer. The study aims to determine if fewer treatments are as effective as more treatments.

Patient Parameters

Program Overview

The purpose of this study is to compare the effectiveness of two different schedules of radiation therapy for men with low or intermediate-risk prostate cancer. Participants will receive either five or two radiation treatments, guided by MRI technology, to see if fewer treatments can achieve the same results as more treatments.

Description

This study is designed to compare two different schedules of radiation therapy for treating prostate cancer. Men with low or intermediate-risk prostate cancer will be randomly assigned to receive either five or two radiation treatments. The treatments will be guided by MRI technology, which helps to precisely target the cancer. The goal is to determine if receiving fewer treatments is just as effective as receiving more treatments, without compromising safety or effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Men aged 18 or older with confirmed low or intermediate-risk prostate cancer.
  • Good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Prostate symptoms score (IPSS) less than 18.
  • Able to undergo MRI-guided radiation therapy.
  • Able to complete a quality of life questionnaire related to prostate cancer.
  • No other medical conditions that would interfere with the study treatment or assessments. Patients with other cancers must have been disease-free for at least 3 years, except for certain skin or bladder cancers.

Exclusion Criteria

  • Previous radiation therapy to the pelvic area.
  • History of inflammatory bowel disease.
  • Prostate size larger than 80 cc on MRI.
  • Advanced prostate cancer stage greater than T3a on MRI.
  • Hip replacements on one or both sides.
  • History of bladder neck or urethral narrowing.
  • Recent prostate surgery (TURP) within 8 weeks before starting radiation therapy.
  • Evidence of cancer spread to pelvic lymph nodes or other distant sites on imaging tests.

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