Page 394 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Appendix Table C2.1. Eligibility criteria, follow-up protocols, triggers for intervention and definition of progression in cohorts of active
surveillance/ watchful waiting/other observational management strategies (continued)

Center, Country Eligibility criteria Followup or monitoring protocol Triggers for intervention/ Definition of
[PMID] active therapy progression
Enrollment year
Western General Early cancer as Every 3 mo for clinical assessment, routine blood tests and Progression of disease and/or Development of
Hospital, UK 142 either incidental measurement of serum markers. Chest X-rays, skeletal X- development of symptoms. metastases (M1) or
[8343901] (T0/stage A) or rays and bone scans were performed every 6 mo. Urinary elevation of PAP to
localized flow rates and residual volumes were assessed if outflow more than 2 u/l.
1978-1990 *T1/stage obstruction was suspected.
B1/B2), non-
metastatic (M0)
disease with
normal serum
PAP.
NR = not reported; 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 = Tans-rectal 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; SPCG-4 =
Scandinavian Prostate Cancer Group Study Number 4; 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; PASS = tthe Canary Prostate Active Surveillance Study; PMID = PubMed identification number.

m Cleveland Clinic Foundation, Memorial Sloan-Kettering Cancer Center, University of British Columbia and University of Miami
n Source: http://www.epi.bris.ac.uk/protect/
o 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.

C-115