New prostate cancer radiotherapy aims to cut side effects
NCT ID NCT06284304
First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times
Summary
This study tests a new way to give radiotherapy for men with intermediate-risk prostate cancer. The goal is to lower the dose to healthy parts of the prostate while boosting the dose to the tumor, using a special MRI-guided machine (MR-linac). Twenty men will take part to see if this approach reduces side effects like urinary and bowel problems, while still controlling the cancer.
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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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20 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Sep 2026
- 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 (Grade groups 1, 2 or 3) 4. MRI stage T2 or less (as staged by AJCC TNM 2018) 5. MRI-visible tumour(s) of PIRADS v2 grade 3 or higher on T2 and diffusion-weighted imaging and/or dynamic contrast-enhanced imaging with concordant pathology 6. Dominant lesion \<50% of prostate on any axial slice and \<50% total prostate volume 7. PSA \<20 ng/ml prior to starting ADT 8. Patients can be concurrently treated with androgen deprivation therapy if this would be standard of care. LHRH analogues or Bicalutamide are permitted. ADT is not mandatory where this would usually be omitted. 9. WHO Performance status 0-2 10. Ability of the participant understand and the willingness to sign a written informed consent form. 11. 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 19 or higher 3. High grade disease (GG3) occult to MRI-defined lesion 4. Post-void residual \>100 mls, where known 5. Prostate volume \>90cc 6. Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up 7. Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging 8. Previous pelvic radiotherapy 9. Patients needing \>6 months of ADT due to disease parameters. 10. 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.
Contacts and locations
Locations
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Netherlands Cancer Institute
Amsterdam, 1066CX, Netherlands
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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