Clinical Trial

Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma

Study acronym: STEREO-RML
Active, Not Recruiting
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Record status
This record was last updated February 13, 2024 (before its estimated October 1, 2025 completion). Its status may not reflect the trial's current state.
Summary
Stereotaxic prostatic radiotherapy on Linac MRI, with monitoring of movements of the pelvic organs per fraction on the prostate in real time, in 4 sessions, with integrated boost on the index tumor (if it is visible on the diagnostic MRI), could reduce the digestive, urinary and sexual toxicities accumulated at 5 years and guarantee excellent local tumor control, for patients with localized prostate cancer, with a favorable prognosis, intermediate or very local high risk, according to the D'Amico classification. The benefits that patients participating in this research could obtain are: * Better disease control efficiency * A reduction in the duration of treatment to 4 radiotherapy sessions (2 weeks maximum) instead of 40 sessions (8 weeks) for usual treatment. * Avoid the risks associated with the implantation of prostate markers necessary for stereotaxic radiotherapy on a standard accelerator (anesthetic risks, infectious risks, hemorrhagic risks, pain risks) * Better quality of life
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2021-05-27.
Status change: Recruiting → Active, Not Recruiting 2024-02-12
Trial Details
NCT Number NCT04909294
Lead Sponsor Centre Georges Francois Leclerc
Conditions Adenocarcinoma of the Prostate
Enrollment 68 participants
Start Date 2020-10-01
Primary Completion 2025-10-01 (estimated)
Study Completion 2030-10-01 (estimated)
Updated on ClinicalTrials.gov 2024-02-13