Page 91 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Table 5. Monitoring criteria in protocols with curative intent in chronological order of starting enrollment year (continued)
Center, Country Monitoring Gleason # biopsy cores PSA Imaging Behavioral Additional laboratory Triggers for
[Pubmed ID] schedule score /% cores indication tests interventions
Enrollment years
l
PRIAS, PSA at 3 mo, >3+3=6 Biopsy protocol PSA DT 0 to 3 yr – – – PSA DT 0 to 3
Netherlands 120 DRE at 6 mo yr, T state >2 or
[19817747] and standard rebiopsy findings
rebiopsy after 1 exceed study
2006 – ongoing yr inclusion
thresholds
PASS, US 121 PSA every 3 mo, Any increase in – PSA DT <3 yr – – – Biochemical
[19758683] DRE every 6 Gleason grade progression;
mo, rebiopsy at clinical
2008 – ongoing 6-12 mo from progression (a
the time of entry, stepwise
at year 2, then increase in
every 2 yr tumor stage by
DRE or
identification of
regional or
distant
metastasis)
DT = doubling time; PSA = prostate-specific antigen; TNM = tumor-node-metastasis system; TURP = transurethral resection of the prostate; yr = yr(s); wk = wk(s); mo = mo(s);
SRCC = Sunnybrook Regional Cancer Center; BCCA = the British Columbia Cancer Agency; DRE = digital rectal examination; WW = watchful waiting; AS = active
surveillance; EM = expectant management; PAP = prostate acid phosphatase; PSA = prostate specific antigen; TRUS = Transrectal ultrasound; CT = computerized tomography;
PSA = prostate-specific antigen; TNM = tumor-node-metastasis system; SRCC = Sunnybrook Regional Cancer Center; BCCA = the British Columbia Cancer Agency; ED =
erectile dysfunction; PRIAS = Prostate cancer Research International; ProtecT = Prostate testing for cancer and Treatment; UCSF=University of California at San Francisco;
European Randomized Study of Screening for Prostate Cancer = ERSPC; VA = Veterans Affairs; MSKCC = Memorial Sloan-Kettering Cancer Center
√ = item was used as part of monitoring strategy but explicit criteria were not defined
– = item was not used or not reported as part of monitoring strategy

f Cleveland Clinic Foundation, Memorial Sloan-Kettering Cancer Center, University of British Columbia and University of Miami
g For the first 4 yr of the study, PSA DT <2y was used as a trigger. This criterion identified 10% of patients as high-risk and was considered overly stringent. In 1999 the cut-off
was increased to 3 yr. From 1995 to 2002 PSA DT was calculated by a statistician using linear regression of all PSA values after the patient left the clinic and the 95% upper bound
confidence limit of PSA DT had to be <3 yr. Later PSA DT was calculated by physicians who used PSA fluctuations to determine whether PSA DT was “truly” <3 yr.
h The model generates 2 reclassification curves (high and low risk) which, when overlaid over PSA data of each patient, defines 3 risk zones of high, intermediate and low risk of
reclassification. A patient with a PSA consistently in the high risk zone is recommended to undergo treatment.
i Clinical progression = at least one of the following: >2 times of the product of the maximum perpendicular diameters of the primary lesion as measured digitally; symptoms
requiring TURP; development of ureteric obstruction; radiological or clinical evidence of distant metastasis.
j Source: http://www.epi.bris.ac.uk/protect/
k Progression criteria: (1) 3 or more positive cores, (2) increased grade (Gleason score 7 or greater) and/or (3) more than 50% of any core involved with cancer.
l PRIAS protocol can be found: http://www.erspc-media.org/media/publications/PRIAS%20Project_background.pdf (assessed 7/15/2011)

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