Page 343 - 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

Center, Country Eligibility criteria Followup or monitoring protocol Triggers for intervention/ Definition of
[PMID] active therapy progression
Enrollment year
Baylor College of Prostate cancer diagnosed by Pathological features of the biopsy results, Definitive treatment when A point system for
Medicine and needle biopsy or transurethral clinical stage and/or PSA influenced the objective progression or evaluating
MSKCC, US 106 resection and Gleason sum 7 decision to proceed with the deferred therapy patients’ requests. progression,
[15017211] or less. All patients were protocol. Definitive treatment included including Gleason
eligible for definitive therapy in Prospectively designed protocol of deferred RP and RT. score increase, PSA
1984-2001 the form of RP or RT. therapy: office evaluations every 3 mo first yr velocity, DRE/TRUS,
No patient had significant and every 6 mo thereafter. It included digital and biopsy
comorbidities. The decision for DRE and PSA. Repeat TRUS guided sextant specimen.
deferred therapy was made by biopsy was recommended at 6 mo or if the
the patient and treating patient showed DRE/TRUS or PSA
physician together based on abnormalities consistent with disease
the likely presence of small progression. PSA velocity was calculated from
volume cancer. 3 separate recorded values in a 12-mo period.
BCCA, Canada 157 Patients who were placed onto a No fixed follow-up schedule; patients generally NR Clinical progression: an
[9445192] watchful waiting program. were seen every 3-6 mo as needed. increase in palpable
Patient who had received PSA at diagnosis and all subsequent followup disease or T
NR treatment (either hormones or PSA were recorded. classification.
PT) prior to the referral were Biochemical
excluded. progression: PSA DT
calculated by 2
methods.
Cleveland clinic, Low-risk features by D’Amico PSA every 6-12 mo, surveillance biopsy was Intervention was NR
US 119 criteria; a repeat (confirmation) usually performed every 2 yr or sooner. recommended to patients
[21256549] prostate biopsy of ≥10 cores; considering multiple
favorable clinical and pathologic parameters (PSA and PSA
2004-2009 features at the diagnostic and kinetics, changes in DRE,
repeat biopsy; absence of quantity of cancer in biopsy
primary or secondary Gleason specimens, and biopsy
scores 4 or 5. Gleason score)

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