Evaluation of the Efficacy and the Safety of a Stereotaxic Prostatic Radiotherapy Delivered With Linac MRI, in Patients With Prostate Adenocarcinoma
Condition(s) studied
Investigational drug(s) / intervention(s)
Stereotactic Radiotherapy with Linac MRI: 38 Gy in 4 fractions of 9.5 Gy over the entire prostate, +/- 2 Gy in 4 fractions of 0.5 Gy as an integrated boost on the index tumor if it is visible on diagnostic multiparametric MRI (PIRADS-V2 score 4 or 5) and on planning MRI performed on Linac MRI.
Study 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
Eligibility
Primary outcome measure(s)
- Late gastrointestinal and urinary toxicity grade ≥ 2 — 5 years
toxicities graded according to the NCI-CTCAE-V5.0
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Centre Georges François Leclerc | Dijon | France |
More Centre Georges Francois Leclerc trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT04909294 on ClinicalTrials.gov ↗ ← All trials in France