Phase 1-2 study, comparing ultra-hypofractionnated (UH) to a moderately hypofractionnated (MH) radiation therapy, with image guided HDR prostate brachytherapy. Using iso-equivalent doses, a non-inferiority analysis will be done in order to prove UH non-inferior to MH, toxicity wise. Acceptability, tolerability, acute and late toxicity will be reported. MRI visible dominant intra-prostatic lesion will be outlines and variability between radiation oncologists and radiologists will be reported. As secondary objective, biochemical and clinical failure free survival will be reported at 5 \& 10 years.
Biopsy proven Prostate adenocarcinoma
Stage T1c, T2 (Annex 2)
Stage Nx or N0
Stage Mx or M0
Age < 18ans
Clinical Stage T3 or T4
Stage N1
Stage M1
Parallel
grade and compare reported side effects between groups
RadiationCompare experimental ultra hypo fractionation (25 Gy in 5 daily fractions administered starting mid week and ending mid following week) to our standard fractionation (either 37,5 Gy given in 15 daily fractions, or 36 Gy in 12 daily fractions). * Toxicity analysis will be quantitatively evaluated using CTCAE (v5) at 1, 2 and 5 years post-therapy, and has needed at FU visits. Kaplan-Meier statistical analysis will be used to report toxicity evolution through time. * median IPSS scores will be reported at 3, 6, 12 months and yearly (1, 2, 3, 4 et 5) post-therapy. IPSS median time to baseline return will be calculated. * IPSS urinary scores, sexual function (SHIM) and GI toxicity (CTCAE-v5) and quality of life questionnaires ( EPIC-26) will be given at 3, 6 months and yearly thereafter (1, 2, 3, 4 et 5) post-treatment.
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
GU toxicity analysis (CTCAE)
quantitatively evaluated using CTCAE (v5) and compare between arms
Clinical outcomes
Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) will be reported using Kaplan-Meier analysis, as well for disease free survival, metastasis free survival and overall survival.
Clinical outcomes
Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) will be reported using Kaplan-Meier analysis, as well for disease free survival, metastasis free survival and overall survival.
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