To present a National Registry of patients with prostate cancer as monitored through active surveillance, with the intention of testing the hypothesis that cancer-specific mortality in very low-risk and low-risk patients is less than 5% at 15 years.
A multicentre observational study (AEU-PIEM/2014/0001) sponsored by the Spanish Association of Urology was conducted using their platform for multicentre studies. The clinical-pathological inclusion criteria were as follows: cT1a-cT3a, PSA ≤20ng/ml, initial minimum biopsy of 10 cores, number of affected cores ≤3, 1st Gleason score of 3 and 2nd Gleason score ≤4 and a known prostate volume (in cc). A unified follow-up was not established for all recruiting centres; however, a survey was conducted that reflects the follow-up characteristics based on a number of tangible parameters that allow for their comparison. With the same philosophy of flexibility, the use of certain biomarkers and multiparametric MRI was not considered necessary for inclusion.
We describe the Registry's characteristics and possibilities, as well as the preliminary results from the 324 patients included in its first 5 months of operation in the 15 recruiting centres. We also report the clinical-pathological variables, biomarkers, radiodiagnosis technique and quality-of-life questionnaires considered for the database, as well as the possibilities for indefinite follow-up, remaining open to any active treatment recognized in clinical guidelines.
The AEU-PIEM/2014/0001 represents an extremely useful tool for all Spanish urologists for multicentre clinical research. The registry will undoubtedly enable the dissemination of active surveillance of our patients in a more coordinated manner, thus maintaining the advantages of optimised opportunistic screening for prostate cancer without resulting in overtreatment.
Actas urologicas espanolas. 2015 Jun 23 [Epub ahead of print]
J Rubio-Briones, A Borque, L M Esteban, I Iborra, P A López, J M Gil, Y Pallás, Ll Fumadó, S Martínez-Breijo, V Chantada, E Gómez, C Quicios, C B Congregado, R Medina, M Ortiz, M Montesino, F Clar, J Soto, J M Campá
Instituto Valenciano de Oncología, Valencia, España. Hospital Universitario Miguel Servet, Zaragoza, España. , Escuela Universitaria La Almunia, Zaragoza, España. , Instituto Valenciano de Oncología, Valencia, España. , Hospital Virgen de la Arrixaca, Murcia, España. , Hospital Universitario Miguel Servet, Zaragoza, España. , Hospital de Manises, Valencia, España. , Hospital del Mar, Barcelona, España. , Hospital Juan Canalejo, La Coruña, España. , Hospital Juan Canalejo, La Coruña, España. , Hospital Universitario Reina Sofía, Córdoba, España. , Fundación Jiménez-Díaz, Madrid, España. , Hospital Universitario Virgen del Rocío, Sevilla, España. , Hospital Universitario Virgen del Rocío, Sevilla, España. , Hospital General Universitario de Elche, Alicante, España. , Complejo Hospitalario de Navarra, Pamplona, España. , Hospital de la Ribera, Alzira, Valencia, España. , Hospital Universitario Puerta del Mar, Cádiz, España. , Hospital Universitario Araba, Álava, España.