Page 12 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Therefore, it is important to clarify the appropriate eligibility criteria and followup protocols for
these observational strategies that could minimize both unnecessary early curative treatments and
avoidable prostate cancer symptoms and deaths. Of course, this assumes that AS is as effective
as (or no worse than) immediate curative treatments in an appropriate subgroup of men
diagnosed with prostate cancer. This, however, remains to be proven. Furthermore, some men
may be uncomfortable with observational management and feel a strong need to “do something,”
and thus AS may be rarely offered, chosen, or adhered to. Therefore, the factors affecting these
actions also warrant further investigation.
The National Cancer Institute and the Centers for Disease Control and Prevention are
sponsoring a National Institutes of Health (NIH) State-of-the-Science Conference in December
2011 to examine these and other essential issues regarding the role of AS (as opposed to
immediate curative intent therapy) in the management of early-stage, low-risk prostate cancer.
The NIH has tasked the Agency for Healthcare Research and Quality (AHRQ) Evidence-based
Practice Center (EPC) Program to provide the present review of evidence for use in this
conference.

Objectives

The objective of this report is to summarize the existing literature regarding the role of AS in
the management of early-stage, low-risk prostate cancer. Both the report and the corresponding
NIH State-of-the-Science conference are a part of the NIH Consensus Development Program, the
purpose of which is to evaluate the scientific evidence on a particular topic and develop a
consensus statement that advances research in that area. This statement is developed by an
independent panel that is assembled for the conference. The panel on AS will hear the scientific
data, including the findings of the present evidence review, and will then use that information to
compose their statement. Additional information about the NIH Consensus Development
Program can be found at: http://consensus.nih.gov/.
The Conference planning committee crafted the Key Questions to be addressed at the
conference, and the EPC was charged with systematically reviewing the relevant literature to
address them. Key Question 1 pertains to temporal trends in the natural history of prostate cancer
in the United States. Key Question 2 relates to the definitions of observational management
strategies (i.e., those involving no active treatment) for prostate cancer used in the published
literature. Key Question 3 relates to the factors that influence the offer or acceptance of or
adherence to AS. Key Question 4 pertains to the comparative effectiveness of AS versus active
treatments for localized prostate cancer. Key Question 5 addresses recommendations for future
research on observational management strategies for localized prostate cancer. The exact
wordings of the Key Questions provided to the EPC for systematic review are as follows:

Key Questions

1. How have the patient population and the natural history of prostate cancer diagnosed in
the United States changed in the last 30 years?
a. Patient Characteristics
i. Age
ii. Comorbidity
iii. Race/ethnicity
b. Tumor Characteristics
i. Stage

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