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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stereotaxic external radiation therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Radiotherapy with Linac MRI | Radiation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Late gastrointestinal and urinary toxicity grade ≥ 2 | toxicities graded according to the NCI-CTCAE-V5.0 | 5 years |
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Inclusion Criteria:
prostate adenocarcinoma
WHO performance index ≤ 1
Patient presenting one of the following cases:
Disease presenting a risk of lymph node involvement <15%
Absence of pelvic or lumbar aortic lymphadenopathy
Absence of bone or visceral metastasis
IPSS score <15 or ≤ 7
Prostate volume estimated by MRI or ultrasound < 90cc
If hormonotherapy, hormone therapy must not have started for more than 60 days before inclusion.
Absence of prior pelvic radiotherapy
No surgical treatment for prostate cancer
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Magali QUIVRIN | Centre Georges François Leclerc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Georges François Leclerc | Dijon | 21000 | France |
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|
| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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