High-Dose-Rate Brachytherapy for Prostate Cancer Recurrence
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
This study is testing a new way to treat prostate cancer that has come back after previous radiation therapy, using a special type of targeted radiation guided by MRI to see if it helps patients feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University Health Network, Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06508567 on ClinicalTrials.gov |
What this trial studies
This interventional trial investigates the feasibility of using MR-guided High-Dose-Rate brachytherapy to treat prostate bed recurrence in patients who have previously undergone radiotherapy. Participants will receive two fractions of 13 Gy each, delivered over a period of 7 to 21 days, with treatment planning based on MRI and PSMA PET imaging. The study will assess patient outcomes through quality of life questionnaires, PSA levels, and imaging follow-ups over a 60-month period.
Who should consider this trial
Good fit: Ideal candidates include men over 18 years old with biopsy-proven isolated prostate bed recurrence following previous radiotherapy.
Not a fit: Patients with evidence of distant metastases or significant prior gastrointestinal or genitourinary toxicities from radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with recurrent prostate cancer after prior radiotherapy.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in localized treatment of recurrent prostate cancer, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients who received previous RT to the prostate bed +/- pelvic nodal regions 2. Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan 3. At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl 4. With or without ADT PSA doubling time from nadir greater than 6 months 5. ECOG 0-2 6. Age greater than 18 years Exclusion Criteria: 1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases 2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT 3. Any contraindications to MR and/or brachytherapy
Where this trial is running
Toronto, Ontario
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Peter Chung, MD
- Email: peter.chung@uhn.ca
- Phone: 416-946-4501
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.