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thus AS may be rarely offered, chosen, or adhered to. Therefore, the factors affecting these
actions also warrant further investigation.
The National Cancer Institute (NCI) and the Centers for Disease Control and Prevention
(CDC) are sponsoring a National Institutes of Health (NIH) State-of-the-Science Conference in
December 2011 to examine 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 an evidence review for use in this conference. The objective of this report is to
summarize the existing literature on 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 (CDP), the purpose of which is to evaluate the
scientific evidence on a particular topic and develop a statement that advances research in this
area. This statement is developed by an independent panel that is assembled for the conference.
The panel will hear the scientific data, including the findings of this evidence review, and will
then use that information to compose their statement. Additional information about the NIH CDP
can be found at the NIH CDP Web site (http://consensus.nih.gov/).
The Conference planning committee crafted the Key Questions to be addressed at the
conference, and the contracted EPC charged with systematically reviewing the 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 (no active
treatment) management strategies 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. And Key Question 5 addresses recommendations for future research on
observational management strategies for localized prostate cancer. It should be noted that this
review primarily concerns active surveillance versus curative treatments. The widespread use of
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primary ADT in localized prostate cancer is outside the scope of this review. The exact wording
of the Key Questions to be addressed is provided below.
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
ii. Tumor volume
iii. Gleason score
iv. PSA
c. Diagnostic Strategies
i. Biopsy Frequency
ii. # of cores
iii. Histopathologic grading changes
d. System Characteristics
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