Status:
RECRUITING
High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy
Lead Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Conditions:
Prostate Cancer
Prostatectomy
Eligibility:
MALE
18-80 years
Brief Summary
The goal of this observational study is to learn about the long-term effects of HDR Brachytherapy in men with isolated local relapses after radical prostatectomy. The main question it aims to answer i...
Detailed Description
HDR brachytherapy appears to be an ideal technique for dose escalation in PET/MRI+ (positron emission tomography) , small, well-defined IPBR that can be accessed and visualized through the perineal ro...
Eligibility Criteria
Inclusion
- Patients with increasing PSA after RP and clinical evidence of PET PSMA/Choline+ and MRI+ isolated prostatic bed relapse (IPBR) that is implantable via transperineal route . The IPBR should be visible on TRUS imaging to allow proper implant placement.
- Pathological confirmation is advised in all cases but it is not mandatory .
- Brachytherapy MRI-based dosimetry
- Patient written Informed Consent of the Institutional Review Board-approved protocol that discloses the investigational nature of the treatment as well as the available standard treatment options.
Exclusion
- Distant Metastases
- Isolated nodal relapses
- Prior Irradiation to the IPBR area
- Multicentric IPBRs
- Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
Key Trial Info
Start Date :
May 5 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 1 2030
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06982469
Start Date
May 5 2020
End Date
May 1 2030
Last Update
June 19 2025
Active Locations (1)
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1
Clínica Universidad de Navarra
Pamplona, Foral Community of Navarre, Spain, 31008