TrialPath
Recruiting

Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

NCT05786742 · CHU de Quebec-Universite Laval
In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

Official title
ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.
About this study
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.
Eligibility criteria
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
Study design
Enrollment target: 205 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2014-04
Estimated completion: 2033-12
Last updated: 2025-09-09
Interventions
Radiation: grade and compare reported side effects between groups
Primary outcomes
  • GU toxicity analysis (CTCAE) (at baseline, prior treatment)
  • GU toxicity analysis (CTCAE) (at 3 months post-therapy)
  • GU toxicity analysis (CTCAE) (at 6 months post-therapy)
Sponsor
CHU de Quebec-Universite Laval · other
Contacts & investigators
ContactAndre-Guy Martin · contact · andre-guy.martin.med@ssss.gouv.qc.ca · 14186915264
ContactJosee Allard · contact · josee.allard@chudequebec.ca · 14186915264
InvestigatorAndre-Guy Martin · study_chair, CHU de Québec
All locations (1)
CHUdeQuebecRecruiting
Québec, Canada
Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost. · TrialPath