Clinical trial Recruiting at 1 site Observational Ages 18 to 80 Men only

High Dose Rate Brachytherapy for Prostate Cancer Recurrence

Official title: 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

Run by Clinica Universidad de Navarra, Universidad de Navarra · NCT06982469 · Data updated 2026-11-12

This study is testing if a special type of radiation treatment called High Dose Rate Brachytherapy can help men with prostate cancer that has come back after surgery feel better and have fewer side effects compared to regular radiation.

Quick facts

Study typeObservational
Ages18 Years to 80 Years
SexMen only
Enrollment20 (estimated)
SponsorClinica Universidad de Navarra, Universidad de Navarra
Academic / other
Drugs / interventionsradiation
Locations1 site (Pamplona, Foral Community of Navarre)
StatusRecruiting
StartedMay 5, 2020
Main results expectedMay 1, 2026
Study endsMay 1, 2030
Registry record updatedJune 19, 2025
Trial IDNCT06982469 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men with rising PSA levels and clinical evidence of isolated prostatic bed relapse that can be treated with HDR Brachytherapy.

Probably not a fit

Patients with distant metastases, isolated nodal relapses, or prior irradiation to the treatment area may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the long-term effects of High Dose Rate (HDR) Brachytherapy in men experiencing isolated local relapses of prostate cancer after radical prostatectomy. The study will compare HDR Brachytherapy with conventional external irradiation to determine if it improves control rates and reduces complications. Participants will receive HDR Brachytherapy as part of their standard medical care, combined with external beam radiation and androgen deprivation therapy to optimize treatment outcomes. The approach utilizes advanced imaging techniques to precisely target the affected areas while minimizing damage to surrounding tissues.

Why it matters

Potential benefit: If successful, this treatment could lead to improved cancer control and fewer side effects for patients with localized prostate cancer recurrence.

How similar studies have gone: Other studies have shown promising results with HDR Brachytherapy, suggesting potential benefits in similar patient populations.

Who can join: the full rules

Show full inclusion / exclusion 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

Where it's running

  • Clínica Universidad de Navarra
    Pamplona, Foral Community of Navarre, Spain
    Recruiting

Study contacts

  • Principal investigator: Rafael Martínez-Monge, M.D. — Clinica Universidad de Navarra Cancer Center
  • Study coordinator: Gabriel Canel, Ph.D.
  • Email: gcanel@unav.es
  • Phone: 948255400

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.