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. 2013 Dec 25;1(1):72–82.

Table 1.

Institutional Active Surveillance Protocols

Institutional Protocols Cohort Size Mean Follow-up (months) Eligibility Criteria Follow-up Methods Disease Progression Predictors % Intervention OS (%) CSS (%)
Johns Hopkins [46] 769 32 •≤ Clinical T1c •PSA/DRE every 6 months •GS > 6 n/a 33.2% at a median of 26 months (26% treated for personal choice without disease progression) 98 100
•PSAD < 0.15 ng/mL2 •Biopsy yearly •# of Positive cores > 2
•GS ≤ 6 •> 50% cancer involvement of any core
•# of Positive cores ≤ 2
•≤ 50% cancer involvement of any core
UCSF [23] 321 43 •≤ Clinical T1/T2a •PSA/DRE every 3 months •Increase in Gleason grade on rebiopsy •Initial PSAD ≥ 0.15 ng/mL2 24% at a median of 36 months after diagnosis (33% treated for personal choice without disease progression) 100 100
•PSA < 10 •Biopsy every 6-12 months (starting 2003, repeat biopsies at 12-24 months) •Increase in PSAV of > 0.75 ng/mL/year •Increase in Gleason grade on rebiopsy
•GS ≤ 6 without grade 4 or 5 •PSADT < 2 years
•cancer involvement < 33% of biopsy cores
Univ. of Miami [51] 230 44 •PSA ≤ 10 •PSA/DRE every 3-4 months for 2 years then every 6 months •Gleason grade > 3 on rebiopsy •Any tumor at the first rebiopsy 14% in a mean follow-up of 33 months 100 100
•GS ≤ 6 •Biopsy in 9-12 months then yearly •Increase in positive number of cores
•# of Positive cores ≤ 2 •Increase in % of tumor in each core
•≤ 20% cancer involvement of any core
Univ. of Toronto [26] 450 82 •PSA ≤ 10 •PSA every 3 months for 2 years then every 6 months •PSADT < 3 years (initially used PSADT < 2 years up until 1999) •PSAD 30% overall (58% of men in the initial intermediate-risk group were treated) 79 97.2
•GS ≤ 6 •Biopsy in 6-12 months then every 3-4 years until age 80 •Increase in Gleason grade on rebiopsy •Gleason score at baseline > 6
•(initially included PSA ≤ 15 and GS 3+4 on men age ≥ 70 up until Jan, 2000) •Clinical progression •Clinical stage at baseline > T2a
MSK [52,53] 238 22 •≤ Clinical T2a •PSA/DRE every 6 months •When eligibility criteria was no longer met •Any tumor at the first rebiopsy n/a n/a n/a
•PSA < 10 •Biopsy in 12-18 months then every 2-3 years
•GS ≤ 6 without grade 4 or 5
•# of Positive core ≤ 2
•≤ 50% cancer involvement of any core
Royal Marsden [50] 326 22 •≤ Clinical T2a •PSA monthly for year 1 then every 3 months in year 2 then every 6 months •PSAV > 1 ng/mL/year •Free-to-total PSA ratio 20% 98 100
•PSA ≤ 15 •DRE every 3 months for 2 years then every 6 months •Primary Gleason grade ≥ 4 •Clinical stage
•GS ≤ 7 with primary grade ≤ 3 •Biopsy at 18-24 months then every 2 years •% Positive biopsy core > 50%
•≤ 50% cancer involvement of any core
PRIAS [54] 2494 19 •≤ Clinical T2 •PSA every 3 months for 2 years then every 6 months •GS > 6 •PSAD 21% 97 100
•PSA ≤ 10 •Biopsy at year 1,4 and 7 •PSADT < 3 years after at least 1 year of follow-up •Number of positive cores (2 vs. 1)
•GS ≤ 6 •Yearly biopsies if PSADT between 3-10 years •≥ 3 positive biopsy cores
•PSAD < 0.2 ng/mL2
•# of Positive cores ≤ 2
NCCN [64] n/a n/a •≤ Clinical T1c (T2a with < 10 yr life-expectancy) •PSA every 6 months •Gleason grade > 3 n/a n/a n/a n/a
•PSA < 10 •DRE every 12 months •Increase in positive number of cores
•GS ≤ 6 •Biopsy as often as every 12 months •Increase in % of tumor in each core
•PSAD < 0.15 ng/mL2
•# of positive cores ≤ 2
•≤ 50% cancer involvement of any core

UCSF=Univ. of California–San Francisco, MSK=Memorial Sloan-Kettering, PRIAS=Prostate Cancer Research International: Active Surveillance, NCCN=National Comprehensive Cancer Network, PSA=prostate-specific antigen, GS=Gleason score, PSAD=prostate-specific antigen density, DRE=digital rectal exam, PSADT=prostate-specific antigen doubling time, PSAV=prostate-specific antigen velocity, OS=Overall Survival, CSS=Cancer-Specific Survival.