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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
StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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
Trial Details
NCT Number NCT04909294
Lead Sponsor Centre Georges Francois Leclerc
Conditions Adenocarcinoma of the Prostate
Enrollment 68 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov