Can less radiation to healthy prostate cut side effects?
NCT ID NCT07391982
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether giving a lower radiation dose to healthy parts of the prostate, while keeping a high dose to visible tumors, can reduce bowel and urinary side effects in men with low or intermediate-risk prostate cancer. Participants will receive two sessions of MRI-guided radiotherapy using an MR-Linac. The trial compares a uniform high dose to the whole prostate against a tailored approach that spares healthy tissue.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- MRI-guided radiotherapy (MR-Linac)
- What this could lead to
- If successful, this approach could reduce bowel and urinary side effects from prostate radiotherapy while still controlling cancer.
- What could go wrong
- This is a small, early-phase study with only 54 participants, so results may not apply to all patients. Lowering the dose could also increase the risk of cancer recurrence.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 54 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men aged ≥18 years 2. Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy 3. Gleason score 3+3, 3+4 or 4+3 (ISUP Grade groups (GG) 1, 2 or 3) 4. 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 5. The MRI-defined lesion must be confirmed as malignant on biopsies (any Gleason grade is sufficient as long as Gleason score is reported). 6. MRI stages mT1 and T2 or mT3a with ≤ 1mm tumour outside gland AND otherwise favourable intermediate risk characteristics (Gleason 3+3, 3+4)(as staged by AJCC TNM 2018) 7. PSA \<20 ng/ml prior to starting androgen deprivation therapy (ADT). 8. WHO Performance status 0-2 9. Ability of the participant to understand and the willingness to sign a written informed consent (IC) form. 10. Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study. Exclusion Criteria: 1. Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia) 2. IPSS Score \> 19 3. 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. 4. Prostate volume \>90cc 5. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up 6. Hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging 7. Previous pelvic radiotherapy 8. Patients needing \>6 months of ADT due to disease parameters. 9. Previous invasive malignancy within the last 2 years excluding basal or squamous cell carcinomas of the skin, low risk non-muscle invasive bladder cancer (assuming cystoscopic follow up now negative) or small renal masses on surveillance.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The Netherlands Cancer Institute
RECRUITINGAmsterdam, 1066CX, Netherlands
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