High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18-80
SponsorClinica Universidad de Navarra, Universidad de Navarra

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Distant Metastases

Isolated nodal relapses

Prior Irradiation to the IPBR area

Multicentric IPBRs

Trial population

Patients with isolated tumor bed relapses after radical prostatectomy

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Brachytherapy

    Radiation

    HDR brachytherapy

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Cohort 11 intervention

Trial outcomes

Primary outcomes

1

biochemical relapse-free survival (bRFS)

Biochemical Relapse-Free Survival

Time frame
5-year

Secondary outcomes

Other outcomes

Sponsors and contacts

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