Platinum Priority – Prostate CancerEditorial by Markus Graefen and Thorsten Schlomm on pp. 604–605 of this issueActive Surveillance for Low-Risk Prostate Cancer Worldwide: The PRIAS Study☆
Introduction
Prostate cancer (PCa) affects many men worldwide, with >900 000 diagnoses and >258 000 deaths from the disease in 2008 [1]. Studies on PCa screening have shown a positive effect of screening, with a reduction of disease-specific mortality of up to 21–30% [2], [3]. However, because of the increasing use of prostate-specific antigen (PSA) testing over the last two to three decades, the proportion of low-risk tumors for which early detection and treatment will not change prognosis has been rising [4]. Treatment of these so-called overdiagnosed cases will inevitably lead to overtreatment and its potential side effects, thereby negatively affecting the patients’ quality of life.
Over the last decade, active surveillance (AS) has evolved as an alternative to radical treatment of low-risk PCa. AS focuses on the prevention of overtreatment by selecting patients with low-risk disease features and strictly monitoring them over time to recognize any potential risk reclassification that would justify deferred radical treatment, still with curative intent. Several AS studies have been initiated worldwide that show quite similar and favorable outcomes. However, follow-up in the majority of cohorts is still short, and prospective validation of criteria for selecting low-risk disease therefore is still lacking. In 2006, the Prostate Cancer Research International: Active Surveillance (PRIAS) study was initiated to counteract overtreatment and contribute to prospective data collection. PRIAS aims to reflect daily practice by collecting data from affiliated centers worldwide using an Internet-based decision tool and the PRIAS protocol. The first data on this study were reported on the first 500 patients in 2009 [5]. This study represents an update of our experience with nearly 2500 patients.
Section snippets
Methods
The PRIAS study started including patients in December 2006, and recruitment is ongoing. More than 100 medical centers in 17 countries worldwide contribute to the collection of data using an Internet-based tool for entering information on patients’ baseline and follow-up characteristics (www.prias-project.org). This report was updated until May 2012. Eligible patients fulfill the PRIAS inclusion criteria for low-risk PCa: clinical stage T1C/T2, PSA ≤10 ng/ml, PSA density (PSA-D) <0.2 ng/ml per
Results
Up to May 2012, 2494 men (median age: 65.8 yr) meeting all inclusion criteria were included in PRIAS. The distribution across participating countries is shown in Table 1. Median follow-up for the cohort was 1.6 yr (25th and 75th percentile [25–75p]: 1.0–2.8 yr). Baseline characteristics of the study group are shown in Table 2.
A total of 1858 repeat biopsies were performed in 1480 men. A first repeat biopsy was done in 1480 patients (79.7%), 308 patients (16.6%) underwent a second repeat biopsy,
Discussion
We report updated results from the largest prospective AS cohort for low-risk PCa that acquires data from >100 medical centers worldwide. Our analyses show that in addition to age and PSA at diagnosis, both PSA-D and the number of positive cores at diagnosis (two compared with one) are important predictors for reclassification at repeat biopsy. The latter two predictors are also shown to be associated with the likelihood of switching to active therapy during follow-up. The majority of patients
Conclusions
In an era of widespread availability of PSA-based screening, AS is of growing interest as an alternative to treatment of low-risk PCa. PRIAS is the largest observational prospective study evaluating AS worldwide and our data support AS as a feasible strategy to reduce overtreatment, at least in the short term, without compromising curability.
Clinical characteristics and PSA kinetics can be used to predict who will be reclassified to higher risk during follow-up and who is more likely to switch
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