Page 375 - 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
Princess Margaret PSA <10 ng/ml, PSA was measured every 3mo for 2 yr and every 6 mo in stable NR Pathologic
hospital, clinical stage patients. DRE was performed every 6 mo. A confirmatory progression:
Canada 156 T1c-T2a, biopsy was typically performed 12 mo after the initial biopsy increased grade,
[21211899] Gleason score and then every 2–3 yr until the patient reached 80 yr of age or increased number of
<6, and ≤3 refused treatment. cores to more than 3
1995-2010 positive biopsy All biopsies were performed by one of three dedicated or any core
cores (<50% of uroradiologists using a standardized approach that did not involvement >50%
a core involved depend on prostate volume Fist-time biopsies consisted of 6
at initial cores before 2001 and 11 cores after 2001. Repeat biopsies
diagnostic consisted of 10 cores before 2001 and 15-16 cores after
biopsy) 2001.
ProtecT, UK 116 Clinically localized PSA every 3 mo in yr 1, and every 6 mo thereafter; referred to The aim of active monitoring NR
[19603015] prostate cancer. biopsy if a PSA ≥3 ng/mL; rebiopsy was not routine is “to identify developing
Patients agreed to cancers early enough to
2000-2008 participate in allow treatment with
RCT and were surgery or radiotherapy” n
allocated to “Test results were reviewed
active annually, and patient and
monitoring clinician decided whether to
group, or continue with monitoring” 152
refused to be (implied using PSA level or
randomly change and/or rebiospy
allocated to results as triggers).
groups and
chose to be
managed by
monitoring.

C-105