Page 383 - 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
Klotz 2010: 125 had to be <3 yr. Later PSA satisfied: PSA DT
Between 1995 DT was calculated by <2 yr, based on at
and 1999, study physicians who used PSA least 3 separate
was offered to fluctuations to determine measurements over
low-risk patients whether PSA DT was a minimum of 6 mo;
(Gleason ≤6 or “truly” <3 yr. In 2005 the final PSA >8 ng/ml;
less, PSA ≤10 group developed a general p-value <0.05 from
ng/ml) and to linear mixed model as a regression of
patients older clinical decision making ln(PSA) on time.
o
than 70 yr old aid. Additional information
with PSA <15 on biopsy frequency
ng/ml or during followup,
Gleason ≤3+4. reported in Klotz
125
Since January 2010 and 129
2000, the study Krakowsky 2010:
was restricted Subsequent
to low-risk biopsies were
patients only. performed every 3-4
yr to identify biologic
progression.
Patients with
borderline PSA DT
underwent biopsies
more frequently.
Between 1995 and
2000 sextant
biopsies were used;
since 2000, 10 to
14-core biopsies
were performed
using the Vienna
nomogram.

C-109