Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.

Recruiting now · Not applicable

Conditions studied: Prostate Cancer, Radiotherapy Side Effect, Hypofractionation, Brachytherapy, Radiotherapy, Localized Prostate Carcinoma

In brief

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.

Key facts

Study ID

NCT05786742

Run by

CHU de Quebec-Universite Laval

People needed

205

Starts

2014-04-01

Expected to finish

2033-12-01

Last updated by the study team

2025-09-09

Who can join

Age: 18 and older, up to 95. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• CHUdeQuebec — Québec, Canada (enrolling)

Full record on ClinicalTrials.gov

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