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NCT Number: NCT06982469

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 Irradiation?

Participants will be asked to receive HDR brachytherapy as part of their regular medical care for isolated local relapses after radical prostatectomy

Recruiting

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Key information

Age range

18 year–80 year

Sex eligibility

Male

Study type

Observational

Primary location

Clínica Universidad de Navarra

Pamplona, Foral Community of Navarre, 31008, Spain

Location status: Recruiting

Location contact

Rafael Martínez-Monge, M.D.

CONTACT

[email protected]

948255400 ext. 5928

About this study

HDR brachytherapy appears to be an ideal technique for dose escalation in PET/MRI+ (positron emission tomography) , small, well-defined IPBR that can be accessed and visualized through the perineal route with transrectal ultrasound (TRUS) guidance. Additionally, HDR brachytherapy can spare from high dose irradiation most of the vesicourethral anastomosis, the external urinary sphincter (EUS) and the penile bulb. This may be crucial in circular structures such as EUS that are particularly sensitive to whole-volume irradiation but tolerate well high small-volume doses provided that the rest of the EUS is spared.

In this study, HDR brachytherapy will be combined with external beam radiation and 6 months of androgen deprivation therapy to decrease the prostate bed volume irradiated at high-doses while increasing the radiation dose in the PET/MRI+ areas.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brachytherapy

Radiation

HDR brachytherapy

Primary outcomes

  1. biochemical relapse-free survival (bRFS)

    Time frame: 5-year

    Biochemical Relapse-Free Survival

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Canel, Ph.D.

CONTACT

[email protected]

948255400 ext. 3300

Sponsors and collaborators

Lead sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2026
Study completion
2030
First posted
May 21, 2025
Registry last updated
Jun 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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