Moderate hypofractionated radiation therapy for high-risk prostate cancer
Moderate Hypofractionated Boost to the Prostate With Pelvic RT in High Risk Prostate Cancer
This study is testing a new radiation treatment for men with high-risk prostate cancer to see if it helps improve their outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05313815 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of a moderate hypofractionated boost to the prostate combined with pelvic radiation therapy in patients with localized high-risk or node-positive prostate cancer. It aims to recruit 100 participants who will receive external beam radiotherapy, with the option of androgen deprivation therapy as per standard care. The study is designed as a single-arm phase II trial, focusing on evaluating treatment outcomes in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates include men over 18 years old with a histologic diagnosis of prostate adenocarcinoma and high-risk localized disease.
Not a fit: Patients who have previously undergone pelvic radiotherapy or have contraindications to radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with high-risk prostate cancer.
How similar studies have performed: Other studies have shown promising results with similar hypofractionated radiation approaches in prostate cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \> 18 years. * Able to provide informed consent. * Histologic diagnosis of prostate adenocarcinoma. * ECOG performance status 0-1. * High-risk localized disease by NCCN criteria (\>cT3, Grade group \>4, or PSA \>20 ng/mL) or clinical N1 disease. * Clinical M0 by conventional imaging (computed tomography (CT) and bone scan (BS)) and/or molecular imaging (prostate specific membrane antigen (PSMA)- positron emission tomography (PET)) Exclusion Criteria: * Prior pelvic radiotherapy. * Contraindications to radiotherapy
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Center — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Rachel Glicksman, MD
- Email: rachel.glicksman@rmp.uhn.ca
- Phone: 416-946-4486
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.