Page 380 - 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
tumor was
Gleason grade
4 and <5%
grade 5.
Taichung Men undergoing After the introduction of serum PSA in 1990, 3-6 monthly PSA No treatment until there was Abnormal DRE and/or
Veterans hospital, TURP for and DRE were used to detect the disease progression. evidence of cancer progressive
Taiwan 143 clinically benign progression. elevation of PSA
[12854876] hyperplasia of “proved” by
prostate with transrectal needle
1983-1996 stage T1a biopsy, or
prostate cancer. appearance of
metastatic disease.
Toronto-SRCC, Histological Every 3 mo for the first 2 yr and every 6 mo thereafter Clinical, histological or PSA Clinical progression =
Canada 114 diagnosis of progression triggered the at least one of the
[11395227] adenocarcinom offer of treatment based on following: >2 times
a of the age, extent of disease and of the product of the
1995-2002 as a prostate within comorbidities. Specific maximum
phase II trial 12 mo of treatment protocol was not perpendicular
enrollment; no reported. diameters of the
2003-ongoing as previous Protocol changes in PSA DT primary lesion as
an observational treatment for assessment, reported in measured digitally;
open prospective prostate Klotz 2010: 125 For the first 4 symptoms requiring
cohort carcinoma; yr of the study, PSA DT TURP; development
clinical stage <2y was used as a trigger. of ureteric
T1b-T2b N0 M0 This criterion identified 10% obstruction;
(1997 TNM of patients as high-risk and radiological or
classification); was considered overly clinical evidence of
PSA ≤15ng/ml; stringent. In 1999 the cut- distant metastasis.
Gleason score off was increased to 3 yr. Histological
≤7. Protocol changes in PSA DT progression =
Protocol changes calculation, reported in Gleason score
130
in inclusion Loblaw 2010: From 1995 upgraded to 8 or
criteria and to 2002 PSA DT was greater in the
additional calculated by a statistician rebiopsy of the
information using linear regression of prostate at 18 mo
regarding the all PSA values after the post enrollment.
original criteria, patient left the clinic and PSA progression =
reported in the 95% upper bound when all the
confidence limit of PSA DT following were

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