RecruitingPhase 3NCT06205316

SBRT Versus Hypofractionated Radiotherapy for Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma

Randomized Phase III Trial of SBRT Versus Hypofractionated Radiotherapy for Salvage of Biochemically Recurrent or Oligometastatic Prostate Adenocarcinoma After Radical Prostatectomy


Sponsor

Mayo Clinic

Enrollment

118 participants

Start Date

Jan 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This phase III trial tests the side effects of stereotactic body radiation therapy (SBRT) compared to hypofractionated radiotherapy for treating patients with prostate adenocarcinoma that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to a limited number of sites (oligometastatic). SBRT is a type of external radiation therapy that uses special equipment to position a patient and precisely deliver radiation to tumors in the body (except the brain). The total dose of radiation is divided into smaller doses given over several days. This type of radiation therapy helps spare normal tissue. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumors cells and have fewer side effects. SBRT may work just as well as hypofractionated radiation therapy at treating patients with biochemically recurrent or oligometastatic prostate cancer, but with a shorter treatment time and possibly fewer side effects.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial compares two types of targeted radiation therapy — SBRT (stereotactic body radiotherapy, a very precise high-dose technique) versus standard hypofractionated radiation — for men with prostate cancer that has come back after surgery, with or without a small number of cancer spread sites. **You may be eligible if...** - You had your prostate removed by surgery and your PSA (a blood marker for prostate cancer) has risen to between 0.1 and 2.0 ng/mL afterward - Your cancer has spread to no more than 5 sites total (oligometastatic) - You have not had prior pelvic radiation or prior hormone therapy with elevated PSA - You are 18 or older and in reasonably good health (ECOG 0–2) **You may NOT be eligible if...** - You have had prior pelvic radiation - You have received hormone therapy and your PSA was 0.1 or higher at that time - You have had a heart attack or severe heart failure in the last 6 months - You have more than 5 sites of cancer spread - You have Crohn's disease or ulcerative colitis affecting the rectum, or a history of urethral stricture Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAntiandrogen Therapy

Receive ADT

PROCEDUREBiospecimen Collection

Undergo blood sample collection

RADIATIONHypofractionated Radiation Therapy

Undergo hypofractionated radiation therapy

PROCEDUREPositron Emission Tomography

Undergo PET scan

RADIATIONStereotactic Body Radiation Therapy

Undergo SBRT

OTHERSurvey Administration

Ancillary study

PROCEDUREMagnetic Resonance Imaging

Undergo MRI


Locations(6)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic Health System in Albert Lea

Albert Lea, Minnesota, United States

Mayo Clinic Health System - Mankato

Mankato, Minnesota, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, United States

Mayo Clinic Health System-Franciscan Healthcare

La Crosse, Wisconsin, United States

View Full Details on ClinicalTrials.gov

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NCT06205316


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