Page 369 - 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
PASS, US 121 Clinical stage T1- PSA every three mo; DER every 6 mo Active treatment will be PSA DT < 3 year, any
[19758683] 2, NX/0, MX/0, Rebiopsy at the baseline visit if a biopsy with >10 cores is not offered to a participant who increase in Gleason
no previous available, at 6-12 mo from the baseline visit, at 2 years, then showed disease grade, and clinical
2008 - ongoing treatment for every 2 years. progression, but the progression
prostate cancer participant may opt to
(including remain on AS. If this
hormone occurs, a new
therapy), ECOG PSA/stage/grade status will
performance be assigned and further
status 0 or 1, progression events will be
elected AS as determined using the new
preferred baseline criteria.
management
plan, If
diagnosis ≤1
year of entry, at
leat 1 biopsy
with ≥10 cores,
if diagnosis >1
year before
entry, minimum
of 2 biopsies, 1
≤2 years
before entry, no
other
malignancies
except skin
cancer or
superficial
bladder cancer

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