European Urology

1. Introduction

With the advent of prostate-specific antigen (PSA) screening and the increase in the number of transrectal ultrasound (TRUS)–guided biopsy cores, there has been a dramatic rise in the incidence of low-risk prostate cancer (LRPC; Gleason 6, T1c, low volume) 1 x H. O’Donnell, C. Parker. What is low-risk prostate cancer and what is its natural history?. World J Urol. 2008;26:415-422 Crossref. , and 2 x M.R. Cooperberg, J.W. Moul, P.R. Carroll. The changing face of prostate cancer. J Clin Oncol. 2005;23:8146-8151 Crossref. . Based on patients identified between1996 and 2003, 91% of new cases of prostate cancer (PCa) were expected to be diagnosed with clinically localized disease and an anticipated 5-yr relative survival approaching 100% [3] x A. Jemal, R. Siegel, E. Ward, Y. Hao, J. Xu, M.J. Thun. Cancer statistics, 2009. CA Cancer J Clin. 2009;59:225-249 Crossref. . As many as 50% of PCa cases detected by screening may be “over-diagnosed,” with 5–12 yr of lead time before treatment becomes necessary [4] x C.J. Savage, H. Lilja, A.M. Cronin, D. Ulmert, A.J. Vickers. Empirical estimates of the lead time distribution for prostate cancer based on two independent representative cohorts of men not subject to prostate-specific antigen screening. Cancer Epidemiol Biomarkers Prev. 2010;19:1201-1207 Crossref. . Interestingly, treatment patterns have not reflected the downward stage and risk migration of these newly diagnosed LRPC patients 5 x P.C. Albertsen, J.A. Hanley, J. Fine. 20-year outcomes following conservative management of clinically localized prostate cancer. JAMA. 2005;293:2095-2101 Crossref. , and 6 x P.J. Bastian, B.H. Carter, A. Bjartell, et al. Insignificant prostate cancer and active surveillance: from definition to clinical implications. Eur Urol. 2009;55:1321-1332 Abstract, Full-text, PDF, Crossref. . Consequently, the dilemma regarding treatment decisions has become more challenging. Because >97% of men with LRPC are likely to die of something other than PCa [7] x M.A. Dall’Era, M.R. Cooperberg, J.M. Chan, et al. Active surveillance for early-stage prostate cancer: review of the current literature. Cancer. 2008;112:1650-1659 Crossref. , it is critical that patients give thought to whether early curative treatment—with a 50% likelihood of negative health-related quality of life (HRQoL) sequelae—is the only option at diagnosis.

The concept of active surveillance (AS) for LRPC has evolved since the 1990s. Initially, watchful waiting (WW) was advanced as a viable strategy for LRPC patients, delaying treatment and its associated comorbidities until clinical progression was observed 8 x L. Klotz. Active surveillance for favorable risk prostate cancer: rationale, risks, and results. Urol Oncol. 2007;25:505-509 Crossref. , and 9 x E.Z. Neulander, R.C. Duncan, R. Tiguert, J.T. Posey, M.S. Soloway. Deferred treatment of localized prostate cancer in the elderly: the impact of the age and stage at the time of diagnosis on the treatment decision. BJU Int. 2000;85:699-704 . Patients electing WW had localized disease but were older or had comorbidities that precluded them from having curative treatment. Often, those treated were prescribed palliative therapy, such as androgen-deprivation therapy. D’Amico et al created preliminary guidelines in 1998 to define LRPC and thus those patients eligible for AS: PSA levels ≤10, Gleason score <7 (no 4 or 5 in biopsy), and stage T1a–2a disease [10] x A.V. D’Amico, R. Whittington, S.B. Malkowicz, et al. Biochemical outcome after radical prostatectomy, external beam radiation therapy, or interstitial radiation therapy for clinically localized prostate cancer. JAMA. 1998;280:969-974 Crossref. . Over the past 10 yr, PSA velocity and density and cancer volume per core have contributed to refining the literature on AS 7 x M.A. Dall’Era, M.R. Cooperberg, J.M. Chan, et al. Active surveillance for early-stage prostate cancer: review of the current literature. Cancer. 2008;112:1650-1659 Crossref. , and 8 x L. Klotz. Active surveillance for favorable risk prostate cancer: rationale, risks, and results. Urol Oncol. 2007;25:505-509 Crossref. .

The goal of this study was to investigate how best to follow LRPC patients who have made the decision to be carefully monitored on AS and to determine what percentage of AS patients were treated. In addition, if patients met the criteria for treatment while on AS, were they likely to be cured with treatment? We also analyzed the data on quality of life (QoL).