NCT06982469Recruiting
High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy
Magnetic Resonance Imaging (MRI)/ Positron Emission Tomography (PET) Prostate-specific Membrane Antigen (PSMA) -Based Phase I-II Study of Salvage HDR Brachytherapy and External Beam Irradiation In Isolated Tumor Bed Relapses After Radical Prostatectomy
Source: ClinicalTrials.gov · Last updated 19 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 13 May 2025
- Start date
- 5 May 2020
- Primary completion date
- 1 May 2026
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Diseases
- Prostate cancer
- NCT number
- NCT06982469
What you commit to
- Study type: Observational
- Planned participants: 20
- From 5 May 2020 to the primary completion date, 1 May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior Irradiation to the IPBR area
Other
- Distant Metastases
- Isolated nodal relapses
- Multicentric IPBRs
- Life expectancy of less than 5 years or inability to tolerate and comply with an HDR procedure
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.