NCT06284304Completed
A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL
Source: ClinicalTrials.gov · Last updated 17 Sept 2026
Brief summary (registry, in English)
Trial design: A single centre phase II non-randomised study Trial population: Men with intermediate risk localised prostate cancer Recruitment target: 20 patients in total Trial objectives: * Primary To develop a 5 fraction de-escalated dose SBRT protocol capable of reducing side effects * Secondary * To assess levels of acute GU and GI toxicity (CTCAE) * To assess levels of late GU and GI toxicity (CTCAE) * To assess late sexual quality of life (expanded EPIC, IIEF-5) * To assess biochemical relapse-free survival at 2 years Trial treatment: All radiotherapy will be delivered on the MR-linac. Intraprostatic dose will be varied according to risk of local recurrence, based on mpMRI, PSA and histology. The whole prostate will receive 30 Gy in 5 fractions and the GTV plus intra-prostatic margin will receive an isotoxic 45 Gy prescription.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 20 (actual)
- First submitted
- 5 Feb 2024
- Start date
- 29 Feb 2024
- Primary completion date
- 4 Sept 2026
- Lead sponsor
- The Netherlands Cancer Institute
- Diseases
- Prostate cancer
- NCT number
- NCT06284304
What you commit to
- Study type: Interventional
- Participants enrolled: 20
- From 29 Feb 2024 to the primary completion date, 4 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindications to MRI (e.g. pacemaker, potentially mobile metal implant, claustrophobia)
- Previous pelvic radiotherapy
Other illness
- High grade disease (GG3) occult to MRI-defined lesion
- Comorbidities which predispose to significant toxicity (e.g. inflammatory bowel disease) or preclude long term follow up
- Patients needing \>6 months of ADT due to disease parameters.
- 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
Other
- IPSS 19 or higher
- Post-void residual \>100 mls, where known
- Prostate volume \>90cc
- Unilateral or bilateral total hip replacement, or other pelvic metalwork which causes artefact on diffusion-weighted imaging
Who the study is looking for
- Men aged ≥18 years
- Histological confirmation of prostate adenocarcinoma requiring radical radiotherapy
- Gleason score 3+3, 3+4 or 4+3 (Grade groups 1, 2 or 3)
- MRI stage T2 or less (as staged by AJCC TNM 2018)
- 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
- Dominant lesion \<50% of prostate on any axial slice and \<50% total prostate volume
- PSA \<20 ng/ml prior to starting ADT
- 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.
- WHO Performance status 0-2
- Ability of the participant understand and the willingness to sign a written informed consent form.
- Ability/willingness to comply with the patient reported outcome questionnaires schedule throughout the study.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Netherlands Cancer Institute Coordinator of this site? Confirm its status | Amsterdam | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.