RecruitingNot Applicable

High Dose Rate (HDR) Brachytherapy Salvage After Prostatectomy

Spain20 participantsStarted 2020-05-05

Plain-language 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

Who can participate

Age range

18 Years – 80 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

biochemical relapse-free survival (bRFS)

Timeframe: 5-year

Trial details

NCT IDNCT06982469

SponsorClinica Universidad de Navarra, Universidad de Navarra

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-05-01

Contact for this trial

Gabriel Canel, Ph.D.

948255400 gcanel@unav.es

View on ClinicalTrials.gov More Prostate Cancer trials