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.