Study on Hypofractionated vs. Conventional Radiation Therapy After Surgery for Prostate Cancer

Sponsor: NRG Oncology

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03274687

Provider View

This clinical trial is comparing two types of radiation therapy given after surgery to treat prostate cancer. It aims to find out if a shorter, higher-dose radiation schedule is as effective and safe as the traditional longer schedule.

Patient Parameters

Program Overview

This study is testing two different radiation therapy schedules for patients who have had surgery for prostate cancer. One method, called hypofractionated radiation therapy, delivers higher doses over a shorter period, while the other, conventional radiation therapy, uses a longer schedule. The goal is to see which method works better at treating prostate cancer after surgery, with fewer side effects.

Description

The main goal of this study is to see if the shorter, higher-dose radiation therapy (hypofractionated) causes more or fewer side effects related to the stomach and urinary system compared to the traditional longer schedule (conventional) two years after treatment.

Secondary goals include comparing side effects at different times after treatment, tracking how long it takes for the cancer to progress, and measuring survival rates. Researchers will also look at the quality of life and collect samples for future research.

Participants will be randomly assigned to one of two groups:

  • Group 1 will receive conventional radiation therapy over 7 weeks.
  • Group 2 will receive hypofractionated radiation therapy over 5 weeks.

Both groups may also receive hormone therapy for up to 6 months if recommended by their doctor. After treatment, participants will have follow-up visits every 6 months for 2 years, then annually for 3 more years.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with prostate cancer and treated with surgery.
  • Any type of prostate surgery is allowed, with no time limit since surgery.
  • Specific cancer stages (pT2 or pT3) and no spread to lymph nodes.
  • No signs of cancer spread to lymph nodes or bones.
  • PSA level less than 2.0 ng/mL after surgery.
  • No local recurrence of cancer in the prostate area.
  • Good overall health with a performance status of 0 or 1.
  • Able to understand and complete the study questionnaire in English or French.
  • Willing to provide informed consent and follow study procedures.

Exclusion Criteria

  • PSA level of 0.2 ng/mL or higher after surgery with a Gleason score of 7 or more.
  • Certain low-risk cancer characteristics.
  • Hormone therapy for more than 6 months before surgery or more than 6 weeks after surgery.
  • Previous chemotherapy or radiation therapy to the prostate area.
  • Severe health conditions like recent heart problems, severe liver disease, or active infections.
  • HIV positive with low CD4 count unless well-managed with treatment.
  • History of severe allergic reactions to study drugs.
  • History of inflammatory bowel disease or certain bowel surgeries.

Get This Program In Your Inbox

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