Page 24 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Followup Protocols
All 16 cohorts included regular PSA testing in the followup protocol. Twelve cohorts
included regular digital rectal examination (DRE). Fourteen cohorts performed routine rebiopsy.
The testing frequency of PSA, DRE, and rebiopsy varied across the cohorts. One cohort also
incorporated a regular bone scan schedule. Criteria for recommending curative treatments varied
across the cohorts. The recommended treatments were not standardized and were left at the
discretion of treating physicians and patients in many of the cohorts.

Gleason Score
Twelve cohorts described using the Gleason score as part of their monitoring criteria for
disease progression. Generally, disease progression was defined as a Gleason score or pattern
greater than those used in the eligibility criteria for AS.

Number of Cores Positive for Cancer
Eight cohorts included the minimum number of biopsy cores positive for cancer as part of
their monitoring criteria for disease progression. Two criteria were used: three or more and
greater than four positive biopsy cores (6 and 3 cohorts, respectively). Rebiopsy frequencies
varied across the cohorts.

Percentage Cancer Involvement in Each Core
Six cohorts used more than 50 percent cancer involvement in each biopsy core as part of
monitoring criteria for disease progression. Two other cohorts considered an increase in tumor
volume as part of the monitoring criteria for disease progression, but specific percentage cancer
involvement was not reported.

Prostate-Specific Antigen
All 16 cohorts included regular PSA testing in the followup protocol. Six cohorts considered
rising PSA and/or PSA kinetics as part of triggers for treatment but did not specify the detailed
criteria. Nine cohorts used a variety of PSA triggers for treatment.

Imaging
One cohort performed an annual bone scan for the first 2 years and biennially thereafter.
Another cohort reported that magnetic resonance imaging of the prostate was selectively
performed every 1 to 3 years during followup.

Behavioral Indicators
No study used a formal assessment of any behavioral indicator for triggering active treatment
as part of their followup protocol, but one cohort reported that some patients requested treatment
due to anxiety related to increasing PSA concentration.

Observational Management Strategies With Palliative Intent

Thirteen cohorts reported followup protocols for patients who initially received no treatment
and who were subsequently treated only for symptomatic progression.

ES-14