MedTrace Logo

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

NCT07391982 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-02-06

No results posted yet for this study

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.

Conditions

  • Prostate Cancer (Adenocarcinoma)

Interventions

RADIATION

uniform dose radiotherapy

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

RADIATION

De-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.

Sponsors & Collaborators

  • MRL Consortium

    collaborator UNKNOWN

  • Elekta Limited

    collaborator INDUSTRY

  • The Netherlands Cancer Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-17
Primary Completion
2027-02-28
Completion
2028-12-31

Countries

  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07391982 on ClinicalTrials.gov