Salvage high-dose-rate brachytherapy for locally recurrent prostate cancer

Is this trial a fit for you?

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

What this trial studies

This is a prospective, multicenter, observational study of salvage HDR brachytherapy for locally recurrent prostate cancer detected by next-generation imaging and biopsy. The primary outcome is biochemical relapse-free survival measured by Phoenix criteria, with secondary outcomes including local relapse-free survival, treatment-related toxicity, and changes in quality of life. Data will be collected on acute and chronic adverse events, as well as patient-reported outcomes using IPSS, FACT-P, and EORTC QLQ-PR25 before and after salvage treatment. Eligible patients have a hormone-sensitive, local recurrence after prior radiotherapy and are scheduled for salvage HDR brachytherapy in routine clinical practice. The study does not specify an interventional protocol beyond standard salvage brachytherapy and focuses on observational outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age over 18 years.
* Patients diagnosed with local recurrence confirmed by next-generation imaging and a positive biopsy.
* Hormone-sensitive patient.
* Patients whose initial treatment consisted of brachytherapy alone, external beam radiotherapy, or external beam radiotherapy with a prostate brachytherapy boost.

Exclusion Criteria:

* Metastatic disease.
* Castration-resistant prostate cancer, defined according to EAU (European Association of Urology) guidelines: A patient who progresses despite maintaining testosterone levels within the castration range (testosterone \<50 ng/dL or \<1.7 nmol/L) and presents with at least one of the following factors: Three consecutive rises in PSA (Prostate-Specific Antigen) levels, measured one week apart, representing two increases of 50% above the nadir, with a PSA level \>2; PSA progression despite successive hormonal manipulations; Progression of bone lesions: progression or appearance of two or more bone lesions, or soft-tissue progression according to Response Evaluation Criteria in Solid Tumors (RECIST criteria).

Where it's running

• Hospital HCB Benidorm
  Benidorm, Alicante, Spain Recruiting
• Instituto Catalán de Oncología L'Hospitalet
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Hospital Universitario Marqués de Valdecilla
  Santander, Cantabria, Spain Recruiting
• Hospital Universitario Reina Sofía
  Córdoba, Córdoba, Spain Recruiting
• Hospital Universitario Ramón y Cajal
  Madrid, Madrid, Spain Recruiting
• Hospital Universitario de Navarra
  Pamplona, Navarre, Spain Recruiting

Study contacts

• Study coordinator: Patricia Willisch Santamaría, MD PhD
• Email: patricia.willisch.santamaria@sergas.es
• Phone: 986 811 714

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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.