NCT05786742 Ultra Hypofractionnated Radiotherapy With HDR Brachytherapy Boost.
| NCT ID | NCT05786742 |
| Status | Recruiting |
| Phase | — |
| Sponsor | CHU de Quebec-Universite Laval |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 205 participants |
| Start Date | 2014-04 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 205 participants in total. It began in 2014-04 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Andre-Guy Martin
STUDY CHAIR
CHU de Québec
Frequently Asked Questions
Who can join the NCT05786742 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 95 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05786742 currently recruiting?
Yes, NCT05786742 is actively recruiting participants. Contact the research team at andre-guy.martin.med@ssss.gouv.qc.ca for enrollment information.
Where is the NCT05786742 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT05786742 clinical trial?
NCT05786742 is sponsored by CHU de Quebec-Universite Laval. The principal investigator is Andre-Guy Martin at CHU de Québec. The trial plans to enroll 205 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.