Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in Spain / NCT07860528
Recruiting Observational

Multicenter Prospective Observational Study on Prostate Salvage Using High-dose-rate Brachytherapy.

NCT07860528 · tracked via the Priya Life Science Spain tracker
Sponsor
Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Phase
Observational
Started
2026-03-11
Last updated
2026-10-06

Condition(s) studied

Prostate CancerLocally Recurrent CancerBiochemically Recurrent Prostate CarcinomaToxicity RadiationQuality of Life

Study summary

A prospective, observational, multicenter study analyzing salvage treatment for prostate cancer-diagnosed via next-generation imaging (Choline PET/PSMA PET), MRI, and positive biopsy-using two fractions of high-dose-rate (HDR) brachytherapy.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • Biochemical relapse-free survival — From the date of salvage brachytherapy to 48 months after treatment
    Time from salvage brachytherapy to biochemical recurrence of prostate cancer, defined according to the Phoenix definition as a rise in prostate-specific antigen (PSA) of ≥2 ng/mL above the post-treatment PSA nadir. Patients without biochemical recurrence will be censored at the date of their last available PSA assessment or at the end of the study follow-up. PSA measurements will be obtained at 1 month after treatment and subsequently every 6 months through 48 months.

Trial sites (10)

FacilityCityRegionStatus
Hospital HCB Benidorm Benidorm Alicante Recruiting
Instituto Catalán de Oncología L'Hospitalet L'Hospitalet de Llobregat Barcelona Recruiting
Hospital Universitario Marqués de Valdecilla Santander Cantabria Recruiting
Hospital Universitario Reina Sofía Córdoba Córdoba Recruiting
Instituto Oncológico de San Sebastián (Onkologikoa) San Sebastián Guipuzcoa Not Yet Recruiting
Hospital Universitario Ramón y Cajal Madrid Madrid Recruiting
Hospital Universitario de Navarra Pamplona Navarre Recruiting
Hospital Meixoeiro Vigo Pontevedra Recruiting
Hospital Universitario y Politécnico La Fe Valencia Valencia Recruiting
Hospital Universitario de Cruces Barakaldo Vizcaya Not Yet Recruiting

More Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic trials in Spain

START-MET HS Prostate Cancer. : SbrT & Androgen Receptor Therapy METastatic HSPC Recruiting
Short Versus Long-term Androgen Deprivation Therapy With Salvage Radiotherapy in Prostate Cancer. URONCOR 0624 Recruiting
Fractionated Stereotactic Radiotherapy Plus Second-generation Antiandrogen for Oligometastatic Castration-resistant Prostate Cancer Patients. Recruiting

Other trials for the same condition

EMG Analysis in ABI: Motor Imagery and Action Recruiting
Intermittent Androgen Deprivation Therapy in the Era of AR Pathway Inhibitors Recruiting
Effect of a Novel Topical Composition on the Incidence of Severe Oral Mucositis in Head & Neck Cancer Radiated Patients and Quality of Life Assessed by PROMs. Recruiting
A Study in Which Non-metastatic Castration-resistant Prostate Cancer (nmCRPC) Patients for Whom a Decision to Treat With Darolutamide Has Been Made Before Enrollment Are Observed and Certain Outcomes Are Described Active, not recruiting
A Study of Abiraterone Acetate Plus Prednisone With or Without Abemaciclib (LY2835219) in Participants With Prostate Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07860528 on ClinicalTrials.gov ↗ ← All trials in Spain