Page 66 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

a
Table 1. Unique AS cohorts
Cohorts or Centers Country Beginning of enrollment
(year)
Baylor College of Medicine and Memorial Sloan-Kettering Cancer US 1984
Center 106
McGill University 107 Canada 1987
University of Connecticut Health Center 108 US 1990
Four tertiary care academic medical canters 109 US 1991
University of Miami 110 US 1991
University of California at San Francisco 111 US After 1991
Royal Marsden Hospital b112 UK 1993
Johns Hopkins 113 US 1994
Toronto- Sunnybrook Regional Cancer Center 114 Canada 1995
Memorial Sloan-Kettering Cancer Center 115 US 1997
ProtecT (Prostate testing for cancer and Treatment Trial) 116 UK 2000
Dana-Farber Cancer Institute 117 US 2000
Kagawa Medical University c118 Japan 2002
Cleveland clinic 119 US 2004
PRIAS (Prostate cancer Research International Active Surveillance) 120 Netherlands 2006
PASS (the Canary Prostate Active Surveillance Study) 121 US 2008
a Cohorts are listed chronologically by enrollment start year. Some cohorts had multiple publications providing different pieces of
information on eligibility criteria and followup protocol. In this case, only the earliest publication was used as the primary
citation of the cohort. Details are described in Tables 3 and 5.
b Royal Marsden Hospital had both AS and WW protocols (described separately). Since 1993, the Royal Marsden Urology Unit
has offered an AS policy as a management option for favorable-risk early prostate cancer.
c The cohort was not an AS cohort before 2002. See the next section, “Observational management strategies with palliative
intent,” for its earlier eligibility criteria and followup protocol.
Common Metrics: Eligibility Criteria for Low-risk or Clinically Localized Prostate Cancer in AS Cohorts (Table 2-3)

The criteria used to identify patients with low-risk or clinically localized prostate cancers
generally varied across the 16 cohorts, with the exception that no cohorts enrolled patients with
clinical stage greater than T2. The most commonly used parameters of patient eligibility criteria
for AS were Gleason score (12 cohorts), PSA (10 cohorts) and number of biopsy cores positive
for cancer (8 cohorts).

Age. Three cohorts reported using age as part of their patient eligibility criteria for AS. 109,118,122
The age criterion was less than 75 years in one multicenter cohort (Cleveland Clinic Foundation,
Memorial Sloan-Kettering Cancer Center, University of British Columbia and University of
109
Miami), less than 80 years in the cohort at University of Miami, 122 and between 50 and 80
years old in the cohort at Kagawa Medical University in Japan. 118 One cohort justified the use of
age as part of patient inclusion criteria to mirror those patients who would otherwise be eligible
for RP or RT due to a life expectancy greater than 10 years at the time of diagnossis; 109 the other
two did not report the reason for including age as part of patient eligibility criteria for AS. 118,122

Gleason score. Twelve cohorts (16 publications) used the Gleason score as part of patient
eligibility criteria for AS (Tables 2 and 3). 106,109-115,117-120,122-125 Nine of the 12 cohorts used
Gleason score 6 or less (or no pattern 4 or 5). The remaining three cohorts allowed Gleason
pattern 4. 111,112,114 Toronto-Sunnybrook Regional Cancer Center cohort changed the Gleason
score criterion that was used to define “favorable-risk” patients for offering AS in the beginning
of the study due to the publication of more convincing evidence of a significant difference in
natural history between Gleason 6 and 7. 126 Specifically, between 1995 and 1999, AS was
offered to all patients who had a Gleason score 6 or less and PSA 10 ng/mL or less, in addition to

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