Page 67 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

older patients (age ≥70 years) with Gleason up to 3+4 or PSA up to 15 ng/mL. Since January
2000, the cohort was restricted to patients who had a Gleason score 6 or less and PSA 10 ng/mL
or less, regardless of age. 114,125

Number of cores positive for cancer. Eight cohorts (11 publications) used a maximal number
of biopsy cores positive for cancer as part of patient eligibility criteria for
AS. 109,110,112,113,115,117,118,120,122-124 Two criteria were used: 2 or fewer (5 cohorts) and 3 or fewer (3
cohorts) positive biopsy cores. It should be noted that the biopsy strategies varied across these
cohorts. For example, some cohorts used sextant (6-core) biopsy, some used octant (8-core)
biopsy, and others performed extended biopsy (>10 cores).

Percentage cancer involvement in each core. Five cohorts (7 publications) used “low-volume
disease” as part of patient eligibility criteria for AS. 110,111,113,115,117,122,123 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 (3 publications), the criterion percent of biopsy cores with
cancer involvement was described variably as less than half of two biopsy cores, 110 less than 20
percent in one or two biopsy cores, 123 and cancer involvement of less than 33 percent of biopsy
cores. 111

PSA. Ten cohorts (14 publications) used PSA as part of patient eligibility criteria for AS (Table
2.2). 109-115,118-120,122-125 Three PSA thresholds were used: ≤10 (7 cohorts), ≤15 (3 cohorts), and
≤20 (2 cohorts) ng/mL. Two cohorts used two different PSA density thresholds (≤0.15 or ≤ 0.2
3
ng/mL/cm ). The number of cohorts do not sum to the total number of cohorts because some
cohorts used multiple criteria. Of these, two cohorts reported changes in the PSA criteria to a
lower threshold in the more recent years. The cohort at Royal Marsden Hospital changed the
PSA threshold from less than or equal to 20 ng/mL to less than or equal to 15 ng/mL in
2002, 112,124 and the cohort at University of Miami changed the PSA threshold from less than or
equal to15 ng/mL to less than or equal to 10 ng/mL in more recent publications (Tables 2 and
3). 110,122,123

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