Page 26 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Percentage Cancer Involvement in Each Core
No cohort used this factor.

Prostate-Specific Antigen
Three cohorts formed in the pre-PSA screening era reported that PSA testing became part of
followup protocol after PSA became available. All six cohorts in the PSA screening era included
regular PSA testing as part of followup protocol. However, rising PSA concentration alone was
not used as a trigger for treatment in five cohorts. The sixth cohort reported that “hormonal
manipulation was demanded by the protocol when the PSA rose to 50 ng/mL.”

Imaging
Five cohorts in the pre-PSA screening era included regular bone scan in the followup
protocol. One cohort also included regular chest and skeletal radiographs in the followup
protocol. Another cohort reported that computed tomography of the pelvis was conducted
infrequently. Three cohorts in the PSA screening era included regular bone scans and chest
radiographs in the followup protocol. Another cohort reported that all patients underwent
“multiple bone scans” during followup.

Behavioral Indications
No cohort explicitly used this factor.

Implicit in the Key Question is a comparison between AS and other observational strategies
in the modern PSA era. Thus, we compared the 16 unique cohorts reporting formal protocols to
monitor triggers for curative treatment with the 7 unique cohorts of other observational strategies
with primarily palliative intent in the PSA screening era. Enrollment into AS protocols more
commonly used Gleason score as a threshold than other observational strategies. They also used
the number and percentage of cores positive for cancer as a threshold, while none of the other
strategies used these factors. Both sets of strategies generally used some sort of PSA criteria, but
the thresholds in AS were generally lower (10-15 ng/mL) than the other observational strategies
(15 or 50 ng/mL). AS protocols had more clearly defined followup processes than other
observational management strategies, with explicit indications for curative treatment including
increase in Gleason scores, number and percentage of positive cores (on rebiopsy), and PSA
velocity. AS protocols generally did not include imaging as part of their followup processes. In
contrast, other observational strategies typically included imaging in their followup, specifically
bone scan and chest radiography. They also generally did not employ rebiopsy but did use PSA
in their followup. Comparison of the followup frequencies between AS and other observational
strategies showed that PSA testing and DRE were common in both strategies, but somewhat
more frequent with AS protocols, at least within the first year of followup.

Key Question 3. What factors affect the offer of, acceptance of, and
adherence to active surveillance?

We included three types of studies to address this Key Question. We included multivariable
database analyses of predictors for the offer or acceptance of or adherence to AS (or WW). We
included survey or questionnaire studies addressing the same issues. We also searched for
experimental studies evaluating the effect of tools, such as decision aids, on the offer or
acceptance of or adherence to AS (however, no such studies were found). Of note, the outcomes

ES-16