Actively Recruiting
Study of HDR Brachytherapy and External Radiation for Prostate Cancer Relapse After Prostatectomy Using MRI and PET Imaging
Led by Clinica Universidad de Navarra, Universidad de Navarra · Updated on 2025-06-19
20
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term effects of high dose rate HDR brachytherapy in men who have isolated local relapses of prostate cancer after undergoing radical prostatectomy. The study aims to find out if HDR brachytherapy improves control rates and reduces complications compared to conventional external irradiation. This observational study focuses on men with prostate cancer recurrence visible on imaging and suitable for HDR brachytherapy. The treatment involves HDR brachytherapy combined with external beam radiation and six months of androgen deprivation therapy. HDR brachytherapy targets small, well-defined tumor areas using imaging techniques like PETMRI and transrectal ultrasound guidance to deliver higher radiation doses while sparing sensitive surrounding tissues. This approach aims to reduce radiation exposure to critical structures such as the external urinary sphincter and penile bulb. Participants will receive HDR brachytherapy as part of their usual medical care and will be monitored for biochemical relapse-free survival over five years. The study includes regular imaging assessments, PSA monitoring, and evaluation of treatment effects and complications. The total participation period covers long-term follow-up to observe outcomes and safety in men treated for isolated prostate bed relapses after prostatectomy.
CONDITIONS
Brief Title
High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 18 to 80 years
- Rising PSA after radical prostatectomy with clinical evidence of isolated prostatic bed relapse (IPBR) positive on PET PSMA/Choline and MRI
- IPBR must be implantable via the transperineal route and visible on transrectal ultrasound
- Pathological confirmation is advised but not mandatory
- Ability to undergo brachytherapy MRI-based dosimetry
- Written informed consent for investigational treatment and standard options
You will not qualify if you...
- Presence of distant metastases
- Isolated nodal relapses
- Prior irradiation to the isolated prostatic bed relapse area
- Multiple isolated prostatic bed relapses (multicentric IPBRs)
- Life expectancy less than 5 years or inability to tolerate and comply with HDR procedure
Research Team
G
Gabriel Canel, Ph.D.
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