Multicenter Prospective Observational Study on Prostate Salvage Using High-dose-rate Brachytherapy.
About this study
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.
- Condition
- Prostate Cancer, Locally Recurrent Cancer, Biochemically Recurrent Prostate Carcinoma, Toxicity Radiation, Quality of Life
- Sponsor
- Instituto de Investigación en Oncología Radioterápica - Fundación Española de Oncología Radioterápic
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Prostate Cancer, Locally Recurrent Cancer, Biochemically Recurrent Prostate Carcinoma, Toxicity Radiation, Quality of Life
- 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 4
- 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
10 sites, 10 recruiting
Hospital HCB Benidorm
Benidorm, Alicante, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba, Spain
Instituto Catalán de Oncología L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Ramón y Cajal
Madrid, Madrid, Spain
Hospital Universitario de Navarra
Pamplona, Navarre, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
and 4 more sites on ClinicalTrials.gov
Contact
-
Patricia Willisch Santamaría, MD PhD
986 811 714 patricia.willisch.santamaria@sergas.es
-
Pablo Raña Díez
914009600 investigacion@seor.es
Potential match only. Final eligibility is determined by the study team.