RecruitingRecruiting
Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
NCT05786742 · CHU de Quebec-Universite Laval
In plain English
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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