NCT06982469 High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy
| NCT ID | NCT06982469 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Clinica Universidad de Navarra, Universidad de Navarra |
| Condition | Prostate Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2020-05-05 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2020-05-05 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
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 procedure
Contact & Investigator
Rafael Martínez-Monge, M.D.
PRINCIPAL INVESTIGATOR
Clinica Universidad de Navarra Cancer Center
Frequently Asked Questions
Who can join the NCT06982469 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06982469 currently recruiting?
Yes, NCT06982469 is actively recruiting participants. Contact the research team at gcanel@unav.es for enrollment information.
Where is the NCT06982469 trial being conducted?
This trial is being conducted at Pamplona, Spain.
Who is sponsoring the NCT06982469 clinical trial?
NCT06982469 is sponsored by Clinica Universidad de Navarra, Universidad de Navarra. The principal investigator is Rafael Martínez-Monge, M.D. at Clinica Universidad de Navarra Cancer Center. The trial plans to enroll 20 participants.
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