Page 11 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Executive Summary

a
Background
In 2011, more than 240,000 men are projected to be diagnosed with prostate cancer, and
33,000 are projected to die from the disease in the United States. In the United States, most cases
of prostate cancer are detected via prostate-specific antigen (PSA) screening. The cancer is
usually localized, and most tumors have low histological grades and low Gleason scores. Indeed,
more than half of prostate cancers detected by PSA screening are expected to be early-stage,
low-risk tumors. Such cancers are an infrequent cause of death, and those affected are more
likely to die of unrelated causes.
A number of immediate active treatment options are available for localized prostate cancer.
Most commonly, radical prostatectomy (RP) or radiation therapy (RT), with or without androgen
deprivation therapy (ADT), are offered with curative intent. However, the clinical benefit of
immediate therapy with curative intent has not yet been demonstrated for localized prostate
cancer in a PSA-screened population. It is likely that a large number of men are receiving active
treatment with curative intent without much likelihood of obtaining any clinical benefit due to
the slow progression of many prostate tumors. Both surgical and radiation treatments result in
significant short- and long-term adverse events, including impotence, urinary dysfunction, and
other complications. Thus, determination of the appropriate management strategy for early-stage,
low-risk prostate cancer is an important public health concern.
Active surveillance (AS) and watchful waiting (WW) are two observational followup
strategies that forgo immediate therapy in patients with prostate cancer, with the goal of
minimizing the morbidities and costs of immediate active treatment for men who may never
develop cancer-related symptoms or who are interested in palliative treatments only. AS is
curative in intent, and WW is palliative. AS is appropriate in men with disease believed to be
indolent and therefore may not require therapy. Because prediction tools are imperfect, these
men are monitored closely and treated with curative intent at signs of progression or patient
choice. In this way, the considerable adverse effects of treatment are at best avoided, and at least
deferred. This approach is to be distinguished from men for whom treatment is deemed
inappropriate because of comorbidity; for these men, WW is generally considered, as it offers the
option of palliative therapy upon symptomatic disease progression. AS often entails a
multifactorial followup of patients—monitoring of PSA values, digital rectal examinations
(DRE), prostate imaging, and periodic prostate biopsies—while WW is commonly a relatively
passive strategy—with interventions triggered by symptoms. However, there is a continuum of
aggressiveness of followup for both AS and WW, as practiced in the community. It should be
noted that even though the two terms are used commonly in the scientific literature, the attended
intents (curative vs. palliative) of these approaches are not always made clear. Furthermore,
many analyses or databases combine AS, WW, and noncurative interventions like primary ADT
in their analyses, making it impossible to ferret out issues specifically related to AS.
Immediate active treatment has tradeoffs, including the harms of short- and long-term
complications from curative treatments and the benefits of potential reductions in long-term
morbidity and mortality. Thus, AS and other observational management strategies may be
considered by men who are more interested in avoiding the risks of curative treatment.

a Please refer to the reference list in the full report for a full documentation of statements contained in the Executive
Summary.

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