Study Comparing Shorter Radiation Therapy to Usual Radiation Therapy for High-Risk Prostate Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05946213

Provider View

This clinical trial is testing whether a shorter course of radiation therapy, given over two weeks, is as effective as the usual longer course of radiation therapy, which lasts 4 to 9 weeks, in treating high-risk prostate cancer.

Patient Parameters

Program Overview

This study is exploring whether a shorter, more intense form of radiation therapy called stereotactic body radiation therapy (SBRT) can treat high-risk prostate cancer as effectively as the usual radiation therapy. SBRT involves five treatments over two weeks, while the usual therapy involves 20 to 45 treatments over 4 to 9 weeks. The trial aims to see if the shorter treatment can prevent cancer from returning just as well as the longer treatment.

Description

The main goal of this study is to compare how long patients live without their cancer spreading to other parts of the body when treated with either the shorter SBRT or the usual longer radiation therapy.

Other goals include:

  • Comparing side effects reported by doctors between the two treatments.
  • Checking if the shorter treatment affects urinary and bowel functions as much as the longer treatment, based on patient feedback.
  • Evaluating patient-reported fatigue and the financial burden of treatment.
  • Comparing how long patients live without their cancer returning and overall survival rates between the two treatments.

The study will also look at:

  • Patient-reported sexual function and overall quality of life.

Participants will be randomly assigned to one of two groups:

  • Group 1 will receive SBRT for 5 treatments over 2 weeks.
  • Group 2 will receive the usual radiation therapy for 20-45 treatments over 4 to 9 weeks.

Participants will have follow-up visits every 6 months for 5 years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer confirmed by lab tests.
  • Considered high-risk due to one or more of the following:
    • Cancer stage cT3a-T3b based on exams or imaging.
    • PSA level over 20 ng/mL before starting hormone therapy.
    • Gleason Score of 8-10.
    • Cancer spread to pelvic lymph nodes as shown by imaging.
  • Prostate gland size less than 100 cc before starting hormone therapy.
  • No signs of cancer spread outside the pelvic area on imaging tests.
  • Age 18 or older.
  • Good overall health with an ECOG performance status of 0-2.
  • No previous radiation therapy to the prostate area that would overlap with this study's treatment.
  • No previous prostate surgery to remove the prostate.
  • Previous hormone therapy for prostate cancer is allowed if started within 185 days before joining the study.
  • Must be enrolled in a related study before starting radiation therapy.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.