Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

NARecruitingINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

April 30, 2014

Primary Completion Date

June 30, 2026

Study Completion Date

December 31, 2033

Conditions
Prostate CancerRadiotherapy Side EffectHypofractionationBrachytherapyRadiotherapyLocalized Prostate Carcinoma
Interventions
RADIATION

grade and compare reported side effects between groups

"Compare experimental ultra hypo fractionation (25 Gy in 5 daily fractions administered starting mid week and ending mid following week) to our standard fractionation (either 37,5 Gy given in 15 daily fractions, or 36 Gy in 12 daily fractions).~* 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."

Trial Locations (1)

G1R 2J6

RECRUITING

CHUdeQuebec, Québec

All Listed Sponsors
lead

CHU de Quebec-Universite Laval

OTHER