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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

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 criteria

Qualifiers

Men aged ≥18 years

Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy

Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3)

MRI-visible tumour(s) of PIRADS v2 grade 3 or higher and able to be delineated on T2 and diffusion-weighted imaging +/- dynamic contrast-enhanced imaging. Tumour nodule visible on MRI should be considered able to be boosted by treating clinician and <2.5cm in maximal dimension. MRI must be performed within 3 months of trial entry

Disqualifiers

Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)

IPSS Score > 19

High grade disease (GG3) occult to MRI-defined lesion. As a guide, any pathology for which you would consider surveillance is allowed outside of the MRI-defined area.

Prostate volume >90cc

Trial design

Treatments tested in this trial

  • uniform dose radiotherapy
  • De-escalated dose radiotherapy

Treatment groups

54 Participants
are divided into 2 treatment groups

Sponsors and collaborators

The Netherlands Cancer Institute

Lead sponsor

MRL Consortium

Collaborator

Elekta Limited

Collaborator