Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost. — HYPO-5  

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.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Brachytherapy
• Hypofractionation
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy
• Radiotherapy Side Effect

• NCT number: NCT05786742
• Study type: Interventional
• Source: CHU de Quebec-Universite Laval
• Contact: Andre-Guy Martin
• Phone: 14186915264
• Email: andre-guy.martin.med@ssss.gouv.qc.ca
• Status: Recruiting
• Phase: N/A
• Start date: April 2014
• Completion date: December 2033