RecruitingNot ApplicableNCT07391982

Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in Two Fractions

Dose De-escalation in Prostate Radiotherapy Using an MR-Linac in 2 Fractions


Sponsor

The Netherlands Cancer Institute

Enrollment

54 participants

Start Date

Nov 17, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to find out whether lowering the radiation dose to parts of the prostate without visible tumor on MRI can reduce side effects while still effectively treating prostate cancer in men with low or intermediate-risk prostate cancer. The main questions it aims to answer are: * Does reducing the radiation dose to healthy prostate tissue lower the risk of bowel and urinary side effects? * Can we maintain good cancer control by keeping a high dose for MRI-visible tumor areas? Researchers will compare two treatment approaches: * One group receives a uniform high dose to the entire prostate. * The other group receives a lower dose to healthy prostate tissue and a high dose only to visible tumor areas. Participants will: * Receive two sessions of MRI-guided radiotherapy using an MR-Linac. * Complete questionnaires about urinary, bowel, and sexual health before and after treatment. * Have follow-up visits to monitor side effects and PSA levels for up to 2 years.


Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a lower radiation dose — delivered very precisely using an MRI-guided radiation machine in just two sessions — is as safe and effective as standard radiotherapy for early-stage prostate cancer. The goal is to reduce radiation dose while targeting the tumor more accurately, potentially lowering side effects. **You may be eligible if...** - You are a man 18 or older with biopsy-confirmed prostate cancer - Your cancer is low to intermediate risk (Gleason score of 3+3, 3+4, or 4+3) - Your MRI shows a visible tumor area that can be targeted, with the tumor less than 2.5cm in size - Your MRI was performed within the past 3 months - You require radical (curative) radiotherapy **You may NOT be eligible if...** - Your cancer has spread beyond the prostate or is high-risk/very high-risk - You cannot have an MRI (e.g., certain metal implants) - You have previously had radiation therapy to the prostate area - You have significant pre-existing bowel or urinary problems 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

RADIATIONuniform dose radiotherapy

27 Gy dose in 2 fractions to the whole prostate+/- seminal vesicles with a 0mm PTV margin using MR-linac

RADIATIONDe-escalated dose radiotherapy

The benign prostate +/- SV CTV will receive 20 Gy in 2 fractions with a 0mm PTV margin using MR-linac. The intraprostatic tumor masses (on MRI) will receive 27 Gy in 2 fractions. A 4mm GTV to PTV margin will be added to the in-traprostatic MR visible tumour to form PTV 27Gy.


Locations(1)

The Netherlands Cancer Institute

Amsterdam, Netherlands

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NCT07391982


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