Page 374 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 374

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.
























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