Recruiting

Ultra Hypofractionated Radiotherapy

Sponsor:

CHU de Quebec-Universite Laval

Code:

NCT05786742

Conditions

Prostate Cancer

Radiotherapy Side Effect

Hypofractionation

Brachytherapy

Radiotherapy

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

grade and compare reported side effects between groups

Study Details

Brief 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.

Conditions

Prostate Cancer

Radiotherapy Side Effect

Hypofractionation

Brachytherapy

Radiotherapy

Study ID

NCT05786742

Start date

Apr, 2014

Status verified date

Sep, 2025

Completion date

Dec, 2033

Anticipated

Primary completion date

Jun, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Accepted

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

205 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ultra hypo fractionation radiation therapy

comparative PRO's of 25 Gy in 5 daily fractions (Ultra hypo fractionation) administered to prostate and 1st centimeter of proximal seminal vesicle, starting mid week and ending mid following week.

active comparator: moderate hypo fractionation radiation therapy

PRO's of moderate hypo fractionation, 37,5 Gy in 15 or 36 Gy in 12 daily fractions administered 5 days per week.

Interventions

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.

Primary outcome measure

  • GU toxicity analysis (CTCAE) [ Time Frame: at baseline, prior treatment ]
  • GU toxicity analysis (CTCAE) [ Time Frame: at 3 months post-therapy ]
  • GU toxicity analysis (CTCAE) [ Time Frame: at 6 months post-therapy ]
  • GU toxicity analysis (CTCAE) [ Time Frame: at 1 year post-therapy ]
  • GU toxicity analysis (CTCAE) [ Time Frame: at 2 years post-therapy ]
  • GU toxicity analysis (CTCAE) [ Time Frame: at 3 years post-therapy ]
  • GU toxicity analysis (CTCAE) [ Time Frame: at 4 years post-therapy ]
  • GU toxicity analysis (CTCAE) [ Time Frame: at 5 years post-therapy ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at baseline, prior treatment ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at 3 months post-therapy ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at 6 months post-therapy ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at 1 year post-therapy ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at 2 years post-therapy ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at 3 years post-therapy ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at 4 years post-therapy ]
  • GI toxicity analysis (CTCAE) [ Time Frame: at 5 years post-therapy ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at baseline, prior treatment ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at 3 months ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at 6 months ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at 1 year ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at 2 years ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at 3 years ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at 4 years ]
  • urinary toxicity analysis (IPSS) [ Time Frame: at 5 years ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: baseline, prior treatment ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: at 3 months ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: at 6 months ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: at 1 year ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: at 2 years ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: at 3 years ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: at 4 years ]
  • quality of life questionnaires analysis (EPIC26) [ Time Frame: at 5 years ]
  • sexual function analysis (SHIM) [ Time Frame: baseline, prior treatment ]
  • sexual function analysis (SHIM) [ Time Frame: at 3 months ]
  • sexual function analysis (SHIM) [ Time Frame: at 6 months ]
  • sexual function analysis (SHIM) [ Time Frame: at 1 year ]
  • sexual function analysis (SHIM) [ Time Frame: at 2 years ]
  • sexual function analysis (SHIM) [ Time Frame: at 3 years ]
  • sexual function analysis (SHIM) [ Time Frame: at 4 years ]
  • sexual function analysis (SHIM) [ Time Frame: at 5 years ]

Central Contacts and Locations

Central contacts

Andre-Guy Martin

14186915264andre-guy.martin.med@ssss.gouv.qc.ca

Josee Allard

14186915264josee.allard@chudequebec.ca

Locations

CHUdeQuebec

Recruiting

Québec, Canada, G1R 2J6

Contacts

Andre-Guy Martin, MD,MSc,FRCPC

1-418-691-5264Andre-Guy.Martin.med@ssss.gouv.qc.ca

Josée Allard, MSc

1-418-691-5264Josee.Allard@chuq.qc.ca

Principal Investigator:

Andre-Guy Martin, MD,MSc,FRCPC

More Information

Sponsor

CHU de Quebec-Universite Laval

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

  • hypo fractionation
  • brachytherapy
  • Ultra Hypo fractionation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by CHU de Quebec-Universite Laval on 2025-09-09.