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A Pilot Study of Dose dE-eScalaTion IN prostATe radIOtherapy usiNg the MRL

NCT06284304 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-04

No results posted yet for this study

Summary

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.

Conditions

Interventions

RADIATION

De-escalated radiotherapy

5 fraction de-escalated dose SBRT protocol

Sponsors & Collaborators

  • The Netherlands Cancer Institute

    lead OTHER

Principal Investigators

  • Floris Pos, MD PhD · The Netherlands Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2027-04-30
Completion
2027-04-02

Countries

  • Netherlands

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06284304 on ClinicalTrials.gov