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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
Sponsor: Centre Georges Francois Leclerc
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
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.
Key Details
Gender
MALE
Age Range
18 Years - 85 Years
Study Type
INTERVENTIONAL
Enrollment
68
Start Date
2020-10-01
Completion Date
2030-10-01
Last Updated
2024-02-13
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (1)
Centre Georges François Leclerc
Dijon, France