RecruitingNot ApplicableNCT05600400

Improving Sexual Quality of Life - Randomized Trial of Two vs Five MRI Guided SABR Treatments for Prostate Cancer

Improving Sexual Quality of Life - A Phase 2 Randomized Controlled Trial of Two Versus Five Stereotactic MRI-Guided Ablative Radiotherapy Treatments for Prostate Cancer

Sponsor

Sunnybrook Health Sciences Centre

Enrollment

144 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Cancer of Prostate Prostate Adenocarcinoma

Summary

Prostate Stereotactic ablative body radiotherapy (SABR) is an established technique that delivers radiation in a non-invasive approach for men with prostate cancer. The treatment regimen is given in total of 5 fractions with one treatment per day at every other day or weekly sessions. Ultra-hypofractionated radiotherapy (UHRT) is an emerging monotherapy for localized prostate cancer however, several trials have observed demonstrating superior biochemical control of a two-fraction (HDR) over single-fraction approach. The study aims to compare an experimental shorter course of prostate ultra-hypofractionated radiotherapy (UHRT) that will deliver what is expected to be an equivalent amount of radiation as given in the standard 5 treatment regimen. UHRT is given in 2 treatments with one treatment a week for 2 consecutive weeks.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study compares two different radiation schedules for treating low- to favorable intermediate-risk prostate cancer: 2 treatments versus 5 treatments using MRI-guided focused radiation (SABR). The main goal is to find out if 2 treatments are just as effective as 5 while also looking at sexual quality of life outcomes. **You may be eligible if...** - You have a confirmed diagnosis of prostate cancer - Your cancer is low risk or favorable intermediate risk (based on your Gleason score, PSA level, and stage) - Your prostate is an appropriate size for the treatment - You are willing to be randomly assigned to one of two treatment schedules **You may NOT be eligible if...** - Your prostate cancer is higher risk or has spread outside the prostate - You have had previous radiation therapy to the pelvis - You have certain urinary problems or prior prostate surgeries that complicate radiation planning - You have metal implants that interfere with MRI 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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