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
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
Research Team
G
Gabriel Canel, Ph.D.
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Clinica Universidad de Navarra, Universidad de Navarra
Lead Sponsor
Who Can Participate
Age: 18Years - 80Years
MALE
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
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Approximately 6 months
Participants receive HDR brachytherapy combined with external beam radiation and 6 months of androgen deprivation therapy to treat isolated prostatic bed relapse after prostatectomy.
Treatment visits as scheduled according to therapy protocol
Long-term Monitoring
Duration - Up to 5 years
Participants are monitored for biochemical relapse-free survival and other outcomes after treatment completion.
Follow-up visits scheduled periodically over 5 years
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Salvage radiotherapy with or without short-term hormone therapy for rising prostate-specific antigen concentration after radical prostatectomy (GETUG-AFU 16): a randomised, multicentre, open-label phase 3 trial.
External-beam radiation therapy and high-dose rate brachytherapy combined with long-term androgen deprivation therapy in high and very high prostate cancer: preliminary data on clinical outcome.
Rafael Martínez-Monge, Marta Moreno, Raquel Ciérvide...
Short-term androgen deprivation therapy combined with radiotherapy as salvage treatment after radical prostatectomy for prostate cancer (GETUG-AFU 16): a 112-month follow-up of a phase 3, randomised trial.
Christian Carrie, Nicolas Magné, Patricia Burban-Provost...