title: Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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 ≤ 20 ng/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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Instituto Valenciano de Oncología, Valencia, España. Electronic address: jrubio@fivo.org.
authors.forename: J
authors.initials: J
authors.lastname: Rubio-Briones
authors.affiliation: Hospital Universitario Miguel Servet, Zaragoza, España.
authors.forename: A
authors.initials: A
authors.lastname: Borque
authors.affiliation: Escuela Universitaria La Almunia, Zaragoza, España.
authors.forename: L M
authors.initials: LM
authors.lastname: Esteban
authors.affiliation: Instituto Valenciano de Oncología, Valencia, España.
authors.forename: I
authors.initials: I
authors.lastname: Iborra
authors.affiliation: Hospital Virgen de la Arrixaca, Murcia, España.
authors.forename: P A
authors.initials: PA
authors.lastname: López
authors.affiliation: Hospital Universitario Miguel Servet, Zaragoza, España.
authors.forename: J M
authors.initials: JM
authors.lastname: Gil
authors.affiliation: Hospital de Manises, Valencia, España.
authors.forename: Y
authors.initials: Y
authors.lastname: Pallás
authors.affiliation: Hospital del Mar, Barcelona, España.
authors.forename: Ll
authors.initials: L
authors.lastname: Fumadó
authors.affiliation: Hospital Juan Canalejo, La Coruña, España.
authors.forename: S
authors.initials: S
authors.lastname: Martínez-Breijo
authors.affiliation: Hospital Juan Canalejo, La Coruña, España.
authors.forename: V
authors.initials: V
authors.lastname: Chantada
authors.affiliation: Hospital Universitario Reina Sofía, Córdoba, España.
authors.forename: E
authors.initials: E
authors.lastname: Gómez
authors.affiliation: Fundación Jiménez-Díaz, Madrid, España.
authors.forename: C
authors.initials: C
authors.lastname: Quicios
authors.affiliation: Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: C B
authors.initials: CB
authors.lastname: Congregado
authors.affiliation: Hospital Universitario Virgen del Rocío, Sevilla, España.
authors.forename: R
authors.initials: R
authors.lastname: Medina
authors.affiliation: Hospital General Universitario de Elche, Alicante, España.
authors.forename: M
authors.initials: M
authors.lastname: Ortiz
authors.affiliation: Complejo Hospitalario de Navarra, Pamplona, España.
authors.forename: M
authors.initials: M
authors.lastname: Montesino
authors.affiliation: Hospital de la Ribera, Alzira, Valencia, España.
authors.forename: F
authors.initials: F
authors.lastname: Clar
authors.affiliation: Hospital Universitario Puerta del Mar, Cádiz, España.
authors.forename: J
authors.initials: J
authors.lastname: Soto
authors.affiliation: Hospital Universitario Araba, Álava, España.
authors.forename: J M
authors.initials: JM
authors.lastname: Campá
mesh_terms: D000328:Adult; D000368:Aged; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000401:mortality / Q000628:therapy*; D012042:Registries; D012189:Retrospective Studies; D012955:Societies, Medical; D013030:Spain; D015996:Survival Rate; D013997:Time Factors; D014572:Urology; D057832:Watchful Waiting
keywords: Active surveillance; Cáncer de próstata; Estudios multicéntricos; Información; Information; Multicentre studies; Prognosis; Pronóstico; Prostate cancer; Vigilancia activa