Prostate Cancer Clinical Trial
Official title:
ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.
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.
Phase 1 : consists in a feasibility study (First 28 patients). Phase 2 : monocentric prospective comparative cohort study. Recruitment : - "Centre intégré de cancérologie du CHU de Québec-Université Laval." - Recruitment period: December 2015 to June 2023 Brachytherapy : - Implantation under general or spinal anesthesia - Foley catheter insertion in bladder. - TRUS prostate localisation. - Prostate volume measurement. - Gold fiducial markers (3) insertion. - Prostate brachytherapy catheters (14 à 21) insertion. - Cystoscopy for bladder and urethra integrity control. - Re-insertion of foley catheter after cystoscopy. Planning imaging: TRUS or CT scan (has needed). Structures delineation by radiation oncologist (brachytherapist). - Prostate - Seminale vesicles - Rectum - Colon sigmoïde - Bladder - Urethra - Penile bulb Dosimetric optimisation - Oncentra Prostate v. 4.2.2 d'Elekta brachytherapy (Veenendaal, The Netherlands) - Oncentra Brachy version 4.6 (if under CT scan). Treatment (brachytherapy dose delivery). - 15 Gy in one fraction - Direct interstitial dose monitoring (20 patients or more). Fiber-optic dosimeter inserted in prostate brachytherpy catheter for live dose delivery mesurements. Foley ablation under full bladder, same day or day after therapy. Radiotherapy: - Via IMRT, VMAT or SBRT technics. - Dose : 25 Gy in 5 fractions administered over a 7 days period. 2 to 3 fractions separated by 2 days, weekend break. - PTV includes prostate and the first centimeter of seminal vesicle. Simulation - one week post brachytherapy - standard has described in the department procedure manual. - maximal CT scan slice thickness : 2-3mm. - uretro-graphy done to identify urogenital sphincter. Multiparametric MRI - If no counter-indication and available, - a T2 tridimensional sequence for prostate delineation - slice thickness : 1 mm. - a diffusion weighted sequence will be done. - a DTI with tractography can be done optionally. - contrast media (gadolinium) is optional. Physique - Linac energy (between 6 MV to 18 MV). - ARC therapy technique will be used - planification softwares: Éclipse, Pinnacle or Raystation. - Portal (kV-kV) imagery will be used for marker match. - CBCT will be done at each fraction delivered. Clinical and dosimetric data will be collected prior treatment. Primary objectives : - 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. Secondary objectives : Biochemical disease-free survival has per Phoenix definition (by American Society of Radiation Oncology - ASTRO) recommendation will be reported using Kaplan-Meier analysis. ;
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