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Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

RecruitingNAAges 18 Years - 95 YearsMaleCHU de Quebec-Universite Laval
NCT05786742 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • grade and compare reported side effects between groups
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Where

1 site
CHUdeQuebec
Québec, Canada
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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