High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy
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 Irradia
| Condition(s) | Prostate Cancer, Prostatectomy, Local Recurrence of Malignant Tumor of Prostate, Radiotherapy; Complications, Brachytherapy |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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 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 |
| Who can participate | Inclusion Criteria: * 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 Criteria: * 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 p |
| Ages | 18 Years to 80 Years |
| Sex | Male |
| Lead sponsor | Clinica Universidad de Navarra, Universidad de Navarra |
| Locations | Pamplona, Foral Community of Navarre, Spain |
| Start date | 2020-05-05 |
| NCT ID | NCT06982469 |
| Official listing | https://clinicaltrials.gov/study/NCT06982469 |