Elsevier

European Urology

Volume 55, Issue 1, January 2009, Pages 1-8
European Urology

Platinum Priority – Prostate Cancer
Editorial by Peter C. Albertsen on pp. 9–11 of this issue
Outcomes of Men with Screen-Detected Prostate Cancer Eligible for Active Surveillance Who Were Managed Expectantly

https://doi.org/10.1016/j.eururo.2008.09.007Get rights and content

Abstract

Background

The incidence of small, localised, well-differentiated prostate cancer (PCa) is increasing, mainly as a result of screening. Many of these cancers will not progress, and radical therapy may lead to substantial overtreatment. Active surveillance (AS) has emerged as an alternative.

Objective

To retrospectively validate the currently used criteria for eligibility for AS.

Design, setting, and participants

For this cohort study, data from 616 men who were diagnosed with PCa between 1994 and 2007 at a mean age of 66.3 yr in four centres of the European Randomized Study of Screening for Prostate Cancer (ERSPC) were combined. All patients fit the criteria for AS (prostate-specific antigen [PSA] ≤10.0 ng/ml, PSA-density <0.2 ng/ml per ml, stage T1C/T2, Gleason score ≤3 + 3 = 6, and ≤2 positive biopsy cores), and initially they were managed expectantly. Median follow-up was 3.91 yr.

Measurements

Disease specific-, overall-, and treatment-free survival were studied. Present PSA characteristics were assessed and also compared between men who were switching to deferred active therapy during follow-up and men remaining untreated.

Results and limitations

The calculated (Kaplan-Meier) 10-yr PCa-specific survival (21 patients at risk) was 100%, which sharply contrasted with 77% overall survival. Men still alive showed favourable PSA characteristics. Although the calculated 10-yr treatment-free survival was only 43%, objective signs of progression often did not indicate the shift to radical treatment. The cohort consisted of men on AS and those on watchful waiting (WW); information on comorbidity or psychological distress was not available.

Conclusions

AS seems justified in selected men with screen-detected PCa. Prospective protocol-based AS programs are necessary to optimise selection criteria and to find the appropriate trigger points for switching to active therapy. Possible negative psychological reactions with AS against improved quality of life by withholding side-effects from radical treatment should be considered.

Introduction

The incidence of prostate cancer (PCa) has been rising during the last 2 decades [1]. Prostate-specific antigen (PSA)–driven screening is probably the most important underlying reason for this trend [2]. In addition to other effects, present screening leads to a more frequent detection of small, localised, well-differentiated malignancies [3], [4].

With death resulting from other causes often occurring before these tumours become harmful, radical treatment may have no effect on PCa-specific survival in these patients [5]. At present, most of these early cancers are radically treated, carrying a chance of serious side-effects [6], [7], [8].

Active surveillance (AS) is an emerging treatment strategy aimed at avoiding overtreatment in patients with PCa. AS consists of initially following men with early PCa and starting curative surgery or radiation therapy (RT), only when progression occurs. AS delays treatment in some men and in others allows treatment to be avoided completely in others [9], [10]. The criteria for inclusion and for switching towards active therapy are not yet evidence based [11].

The present multicenter study aims to validate the currently used criteria for eligibility for AS, by retrospectively studying outcome measures in men with screen-detected PCa that fits these criteria and who were managed expectantly.

Section snippets

Methods

Men included in this study all participated in the screening arm of the European Randomized Study of Screening for Prostate Cancer (ERSPC), had been diagnosed with PCa, and initially had elected expectant management. The data cohorts of four centres in three countries were combined, that is, Rotterdam in the Netherlands, Gothenburg in Sweden, and Helsinki and Tampere in Finland.

The ERSPC-screening protocol (applied to men aged 50–75 yr) consists of PSA measurements (threshold 3.0 or 4.0 ng/ml),

Results

In total, 988 men were primarily managed expectantly after PCa diagnosis; of those, 616 (62.3%) conformed to the PRIAS criteria for AS. Of the 372 (988 – 616) excluded men, 49 had a PSA level >10.0 ng/ml (12 unknown), 130 had a PSA density ≥0.2 ng/ml per ml (89 unknown), 4 had disease stage >T2 (24 unknown), 54 had Gleason score >3 + 3 = 6 (24 unknown), and 108 had more than two positive biopsy cores (93 unknown). One man had positive lymph nodes at the time of diagnosis, and one had distant

Discussion

We retrospectively studied PCa-specific-, overall-, and treatment-free survival of men with screen-detected PCa that was initially managed expectantly and who would have been suitable for AS according to contemporary practice. In the first screening round of the Rotterdam section of the ERSPC, 21.8% of all men who were possibly suitable for AS were actually treated expectantly [19].

Differences between the four centres in patient selection and follow-up were small but significant. These can be

Conclusions

This retrospective ERSPC multicenter study confirms that expectant management is a part of the clinical management of screen-detected PCa. The border between AS and WW is not distinct. Men with screen-detected PCa that fits current criteria for AS have a favourable PCa-specific prognosis, after initially choosing an expectant management; after 10 yr of follow-up, 100% survived their PCa, whereas almost one-fourth had died of other causes. On the basis of present PSA characteristics, it is also

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