Study Comparing Two Types of Radiation Therapy for Recurrent or Limited Spread Prostate Cancer

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT06205316

Provider View

This clinical trial is comparing the side effects and effectiveness of two types of radiation therapy, SBRT and hypofractionated radiotherapy, for treating prostate cancer that has returned or spread to a few areas. The study aims to find out if SBRT can work as well as the other method but with fewer side effects and a shorter treatment time.

Patient Parameters

Program Overview

This study is testing two different radiation treatments for prostate cancer that has come back or spread to a few places. One treatment, called SBRT, uses precise radiation to target tumors and is given in smaller doses over a few days. The other treatment, hypofractionated radiotherapy, uses higher doses over a shorter time. The goal is to see if SBRT is as effective as the other treatment but with fewer side effects and a shorter treatment period.

Description

The main goal of this study is to see if SBRT is as good as hypofractionated radiation therapy in terms of side effects related to urinary and digestive systems within two years.

The study will also look at:

  • How long patients stay free of cancer after treatment.
  • Side effects related to urinary and digestive systems three years after treatment.
  • Quality of life after treatment.
  • The need for additional hormone therapy.
  • Overall survival rates and cancer-specific survival rates five years after treatment.

The study will also explore how prostate and normal tissue move during radiation therapy and how AI tools can help in treatment planning.

Participants will be randomly assigned to one of two groups:

  • Group I: Will receive SBRT every other day for 5 sessions over 1-2 weeks. They may also receive hormone therapy for up to 18 months if needed.
  • Group II: Will receive hypofractionated radiation therapy once a day for 20 sessions over 4-6 weeks. They may also receive hormone therapy for up to 18 months if needed.

Both groups will have scans and blood tests throughout the study. After treatment, follow-up visits will occur at 3 months, 12 months, annually until year 5, and then every other year.

Eligibility Criteria

Inclusion Criteria

  • Confirmed prostate cancer at the time of surgery.
  • Cancer stages T2-T3b, Nx or N0-1, M0-1.
  • PSA levels between 0.1 and 2.0 ng/mL after surgery.
  • Good overall health with an ECOG score of 0, 1, or 2.
  • Must sign informed consent.
  • Must complete all required tests before starting.
  • Must start treatment within 120 days of registration.
  • Must be 18 years or older.
  • Cancer spread to no more than 5 sites.

Exclusion Criteria

  • Previous radiation to the pelvic area.
  • Previous hormone therapy for prostate cancer with PSA ≥ 0.1 ng/mL.
  • Active bowel diseases like rectal diverticulitis or Crohn's disease affecting the rectum.
  • Previous chemotherapy for prostate cancer.
  • History of urethral stricture needing treatment.
  • Serious medical, mental health, or addiction issues that could interfere with the study.
  • Recent heart attack or severe heart failure.
  • On a transplant list.
  • Cancer spread to more than 5 sites.

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