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