Page 23 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Strategies With Curative Intent

Sixteen unique cohorts reported criteria and protocols for AS (i.e., studies that met our
criteria of monitoring triggers for curative treatment of prostate cancer other than symptom
progression). In all cohorts, AS was offered to men with low-risk or clinically localized prostate
cancer.

Eligibility Criteria
Other than restriction to men with clinically localized prostate cancer (T1 or T2), eligibility
criteria for AS varied across the cohorts. The most commonly used eligibility parameters were
Gleason score (12 cohorts), PSA (10 cohorts), and number of biopsy cores positive for cancer (8
cohorts).

Age
Only three studies used age as an eligibility criterion, restricting subjects to men under age 70
or 80 years.

Gleason Score
Twelve cohorts based eligibility for AS on the Gleason score. Generally, cohorts used
Gleason score of 6 or less (no pattern 4 or 5). Three cohorts allowed Gleason pattern 4.

Number of Cores Positive for Cancer
Eight cohorts used a maximal number of biopsy cores positive for cancer as part of the
eligibility criteria for AS. Five cohorts allowed two or fewer cancer-positive cores; three cohorts
allowed three or fewer. Some cohorts used sextant, some octant, and some extended (>10 cores)
biopsies.

Percentage Cancer Involvement in Each Core
Five cohorts used “low-volume disease” as part of the patient eligibility criteria for AS. In
three cohorts, the definition of “low-volume disease” was involvement of less than half of any
individual core with cancer. In the other two cohorts, the criterion percent of biopsy cores with
cancer involvement was described variably as less than half of two biopsy cores, less than 20
percent in one or two biopsy cores, and less than 33 percent of biopsy cores.

Prostate-Specific Antigen
Ten of 16 cohorts used PSA as part of the eligibility criteria for AS. Three PSA thresholds
were used: ≤10 (7 cohorts), ≤15 (3 cohorts), and ≤20 (2 cohorts) ng/mL. Two cohorts used PSA
density (PSA per volume of prostate tissue) thresholds.

Imaging
One cohort required a chest radiograph as part of patient eligibility criteria, and another
cohort noted that magnetic resonance imaging was selectively used at diagnosis.

Behavioral Indicators
No behavioral indicator was used explicitly as a criterion for AS enrollment.

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