Focal brachytherapy boost combined with stereotactic radiotherapy for prostate cancer
Focal HDR Brachytherapy Boost to Stereotactic Radiotherapy
This study is testing a new combination treatment for prostate cancer to see if it causes less urinary problems and improves quality of life compared to standard care.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Sex | Male |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) Academic / other |
| Locations | 2 sites (Montreal, Quebec and 1 other locations) |
| Trial ID | NCT04100174 on ClinicalTrials.gov |
What this trial studies
This Phase II trial aims to evaluate the effectiveness of a focal brachytherapy (fBT) boost combined with stereotactic radiotherapy (sRT) in treating prostate cancer. The study compares this approach to standard care, focusing on urinary toxicity and quality of life outcomes. Participants will be monitored for changes in urinary irritation and obstruction over a period of 12 to 24 months using electronic patient-reported outcomes. The goal is to determine if the new treatment method results in fewer patients experiencing significant declines in urinary quality of life.
Who should consider this trial
Good fit: Ideal candidates are men with histologically confirmed prostate cancer who are eligible for curative-intent HDR brachytherapy boost to external beam radiotherapy.
Not a fit: Patients with extensive disease affecting more than 50% of the prostate gland may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could lead to reduced urinary side effects for prostate cancer patients undergoing radiotherapy.
How similar studies have performed: Other studies have explored similar approaches, but this specific combination of treatments is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histological diagnosis of prostate cancer planned for curative-intent HDR brachytherapy boost to external beam radiotherapy to the prostate gland. * ECOG 0-1 * Charlson Comorbidity Index ≤ 4 * Imaging visible disease encompassing \< 50% of the prostate gland and consistent with biopsy findings. Exclusion - none
Where this trial is running
Montreal, Quebec and 1 other locations
- Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada (Recruiting)
- Chuq — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: Mom Phat
- Email: mom.phat.chum@ssss.gouv.qc.ca
- Phone: 514-890-8254
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.