Comparing two types of radiation therapy for prostate cancer treatment
ULTRA-HYPO Fractionated (UHF) Compared to Moderate-HYPO Fractionated (MHF) Prostate IGRT With HDR Brachytherapy BOOST : A Phase 1-2 Study.
This study is testing whether a new type of radiation therapy for prostate cancer works better and is safer than a different method, while also looking at how well the treatment is tolerated by patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 205 (estimated) |
| Ages | 18 Years to 95 Years |
| Sex | Male |
| Sponsor | CHU de Quebec-Universite Laval Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Québec) |
| Trial ID | NCT05786742 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness and safety of ultra-hypofractionated radiation therapy compared to moderately hypofractionated radiation therapy, combined with high-dose-rate brachytherapy for prostate cancer. It involves a feasibility phase with 28 patients followed by a comparative cohort study. The study aims to assess toxicity, acceptability, and long-term survival outcomes while monitoring the precision of radiation delivery using advanced imaging techniques. The trial is conducted at the Centre intégré de cancérologie du CHU de Québec-Université Laval.
Who should consider this trial
Good fit: Ideal candidates include men with biopsy-proven prostate adenocarcinoma at specific stages (T1c, T2) and with a Gleason score of 6 or 7.
Not a fit: Patients with advanced prostate cancer (T3 or T4), high Gleason scores (8-10), or those who have had prior pelvic radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and less toxic radiation treatment options for prostate cancer patients.
How similar studies have performed: Other studies have shown promising results with hypofractionated radiation therapy approaches, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Québec
- CHUdeQuebec — Québec, Canada (Recruiting)
Study contacts
- Study coordinator: Andre-Guy Martin
- Email: andre-guy.martin.med@ssss.gouv.qc.ca
- Phone: 14186915264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.