The management of active surveillance in prostate cancer: validation of the Canary Prostate Active Surveillance Study risk calculator with the Spanish Urological Association Registry.

Ángel Borque-Fernando,Luis Mariano Esteban,Lluis Fumadó,José Rubio-Briones,Jorge Huguet-Pérez,Enrique Gómez-Gómez,Jesús Manuel Gil-Fabra,Argimiro Collado-Serra,Sara Martínez-Breijo,José Ignacio Sanz-Vélez,Cristina Quicios-Dorado,Pedro Ángel López-González,Juan Soto-Villalba,Yoni Pallás-Costa

doi:10.18632/oncotarget.21984

Abstract

The follow up of patients on active surveillance requires to repeat prostate biopsies. Predictive models that identify patients at low risk of progression or reclassification are essential to reduce the number of unnecessary biopsies. The aim of this study is to validate the Prostate Active Surveillance Study risk calculator (PASS-RC) in the multicentric Spanish Urological Association Registry of patients on active surveillance (AS), from common clinical practice.ResultsWe find significant differences in age, PSA and clinical stage between our validation cohort and the PASS-RC generation cohort (p < .0001), with a reclassification rate of 10–22% on the follow-up Bx, no cancer was found in 43% of the first follow-up Bx. The calibration curve shows underestimation of real appearance of reclassification. The AUC is 0.65 (C.I.95%: 0.60–0.71). PDF and CUC do not suggest a specific cut-off point of clinical use.MethodsWe select 498 patients on AS with a minimum of one follow-up biopsy (Bx) from the 1,024 males registered by 36 Spanish centers recruiting patients on the Spanish Urological Association Registry on AS. PASS-RC external validation is carried by means of calibration curve and area under de ROC-curve (AUC), identifying cut-offs of clinical utility by probability density functions (PDF) and clinical utility curves (CUC).ConclusionsIn our first external validation of the PASS-RC we have obtained a moderate discrimination ability, although we cannot recommend cut-off points of clinical use. We suggest the exploration of new biomarkers and/or morpho-functional parameters from multiparametric magnetic resonance image, to improve those necessary tools on AS.

Highlights

Active surveillance (AS) is increasingly being implemented by urologists as a strategy that provides the benefits from prostate cancer (PCa) opportunistic screening observed in western countries [1], but avoids overtreatment
We suggest the exploration of new biomarkers and/or morpho-functional parameters from multiparametric magnetic resonance image, to improve those necessary tools on AS
These wider inclusion criteria are contemplated in other AS registers such as the Canary Prostate Active Surveillance Study (PASS) [3], in contrast with the more strict inclusion criteria used by previous series [4,5,6,7,8,9,10]

Summary

Introduction

Active surveillance (AS) is increasingly being implemented by urologists as a strategy that provides the benefits from prostate cancer (PCa) opportunistic screening observed in western countries [1], but avoids overtreatment. We have presented our National Registry (AEU/PIEM/2014/0001, www.piem.aeu.es) supported by the Spanish Urological Association (Asociación Española de Urología, AEU) [2] This initiative was created with the aim of facilitating the implementation of AS in all types of Hospitals, and of providing an opportunity for multicentric clinical research, as different inclusion criteria and followup strategies are allowed. These wider inclusion criteria are contemplated in other AS registers such as the Canary Prostate Active Surveillance Study (PASS) [3], in contrast with the more strict inclusion criteria used by previous series [4,5,6,7,8,9,10]. This tool showed an area under the curve (AUC) of 72.4% for reclassification in the follow-up Bx, providing an on-line tool to facilitate counselling for the patients on AS [15]

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