RecruitingNot ApplicableNCT06518226

Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer

Two-Fraction Ultrahypofractionated Radiotherapy With Focal Boost for Intermediate Risk, Localized Prostate Cancer (TURBO): Phase 2, Randomized Controlled Clinical Trial

Sponsor

UMC Utrecht

Enrollment

160 participants

Start Date

Mar 28, 2024

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Prostate Adenocarcinoma Localized Prostate Carcinoma

Summary

The goal of this clinical trial is to assess the non-inferiority irradiating low and intermediate risk, localized prostate cancer in two fractions of radiotherapy, compared to five fractions of radiotherapy which is the standard of care. The main question it aims to answer are: \- Do participants in the interventional arm have more physician-reported grade 2 or higher acute Common Terminology Criteria for Adverse Events (CTCAE) genitourinary (GU) side effects? Participants in the intervention arm will receive two fractions of radiotherapy, in which the prostate is irradiated with 12 Gy per fraction and the tumor receives a boost of up to 13.5 Gray (Gy), over the course of 8 days. Those in the control arm will receive five fractions of radiotherapy of 7.25 Gy each to the prostate, without a boost to the tumor, over the course of 16-18 days.

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an ultra-shortened radiation course — just 2 treatment sessions instead of the usual 20–40 — for men with intermediate-risk localized prostate cancer. Each session delivers a precisely targeted, high dose of radiation with an extra boost to the tumor, using MRI-guided technology to protect nearby healthy tissue. **You may be eligible if...** - You are 18 or older - You have confirmed prostate cancer (adenocarcinoma) requiring active treatment - Your cancer is classified as intermediate risk: PSA below 20 ng/mL, Gleason score 7 or less, and tumor limited to the prostate (stage T1c–T2b or non-bulky T3a) - You are enrolled or eligible for the MOMENTUM MR-Linac study **You may NOT be eligible if...** - Your cancer is low risk or high risk (outside the intermediate category) - You have had prior prostate radiation - You have a hip replacement or other implants that would distort MRI imaging - You have severe urinary symptoms that would worsen with radiation 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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