Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer

Abstract Objectives 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. Material and 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 cm 3 ). A unified follow-up was not established for all recruiting centers; 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 centers. We also report the clinical–pathological variables, biomarkers, radiologic techniques 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 difussion M&M of active surveillance of our patients in a more coordinated manner, thus maintaining the advantages of optimized opportunistic screening for prostate cancer without resulting in overtreatment.