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

Adenocarcinoma of the Prostate Clinical Trial

Official title: Multicenter Phase II Study Evaluating the Efficacy and Safety of a Stereotaxic Prostatic Radiotherapy Delivered on Linac MRI, With Integrated Boost in the Case of an Index Tumor, in Patients With Prostate Adenocarcinoma of Favorable, Intermediate or Risky Risk. High Risk Very Localized.

Status Active, not recruiting

Clinical Trial 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

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of the Prostate

• NCT number: NCT04909294
• Study type: Interventional
• Source: Centre Georges Francois Leclerc
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 1, 2020
• Completion date: October 1, 2030