Real World Evidence of Active Surveillance for Prostate Cancer in Spain; Midterm Results

Abstract

Active surveillance; Prostate cancer; Spain

Vigilancia activa; Cáncer de próstata; España

Vigilància activa; Càncer de pròstata; Espanya

Patients and Methods In this multicenter longitudinal study, data from the Spanish Register in AS (AEU-PIEM/2014/0001) were reviewed. The study focused on a cohort of AS patients registered between 2014 and 2019, featuring open inclusion criteria and diverse follow-up strategies. Results A total of 3315 AS patients were recruited, with 2881 and 434 categorized into the low and intermediate risk groups based on NCCN grouping at inclusion. The median age was 67 years, and only 11% underwent diagnostic biopsy guided by MRI. The median time between follow-up visits was 6.03 months. Over a median follow-up of 62 months (Q1–3: 43.78–85.58), 37% remained in AS, while 8% transitioned to watchful waiting due to aging or intercurrent disease. Death occurred in 199 (6%) of patients, with 3 due to prostate cancer progression and 196 attributed to other causes. At 2 and 5 years, pathological progression-free survival, metastasis-free survival, and active treatment-free survival were 68% and 51%, 99% and 99%, and 70% and 50%, respectively. Conclusions Midterm oncological outcomes of AS in Spain align with major international series. We denote underuse of guideline recommendations such as use of MRI or TP Bx for initial PCa characterization. Collaborative efforts are crucial in the search for algorithms, new imaging, or biomarkers to refine indications and transition to active treatments. Trial Registration ClinicalTrials.gov identifier: NCT02865330