About this trial
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 is:
Does HDR Brachytherapy increase control rates and decreases complications compared with conventional External Irradiation?
Participants will be asked to receive HDR brachytherapy as part of their regular medical care for isolated local relapses after radical prostatectomy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Distant Metastases
Isolated nodal relapses
Prior Irradiation to the IPBR area
Multicentric IPBRs
Trial population
Patients with isolated tumor bed relapses after radical prostatectomy
Trial design
Cohort
Prospective
Treatments tested in this trial
Brachytherapy
RadiationHDR brachytherapy
Treatment groups
Trial outcomes
Primary outcomes
biochemical relapse-free survival (bRFS)
Biochemical Relapse-Free Survival
Sponsors and contacts
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