Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

Summary

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.

Eligibility

Inclusion Criteria:

* Biopsy proven Prostate adenocarcinoma
* Stage T1c, T2 (Annex 2)
* Stage Nx or N0
* Stage Mx or M0
* PSA \< 20ng/ml
* Gleason Score 6 or 7
* Having the ability to sing a written consent

Exclusion Criteria:

* Age \< 18ans
* Clinical Stage T3 or T4
* Stage N1
* Stage M1
* PSA \> 20
* Gleason Score 8 to 10
* IPSS Score \> 20 alpha-blocking medication.
* Prior pelvic radiotherapy.
* History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
* Past history of Inflammatory Bowell Disease
* Bilateral hip prosthesis

Conditions7

Browse More Trials