NCT05786742Recruiting
Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.
Source: ClinicalTrials.gov · Last updated 9 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 205 (estimated)
- First submitted
- 23 Dec 2022
- Start date
- Apr 2014
- Primary completion date
- Jun 2026
- Lead sponsor
- CHU de Quebec-Universite Laval
- Diseases
- Prostate cancer
- NCT number
- NCT05786742
What you commit to
- Study type: Interventional
- Planned participants: 205
- From Apr 2014 to the primary completion date, Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- IPSS Score \> 20 alpha-blocking medication.
- Prior pelvic radiotherapy.
Other illness
- History of active collagenosis (Lupus, Sclerodermia, Dermatomyosis)
- Past history of Inflammatory Bowell Disease
Age
- Age \< 18ans
Other
- Clinical Stage T3 or T4
- Stage N1
- Stage M1
- PSA \> 20
- Gleason Score 8 to 10
- Bilateral hip prosthesis
Who the study is looking for
- 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
Age in the registry: 18 years to 95 years · Sex: Male · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHUdeQuebec Coordinator of this site? Confirm its status | Québec | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.