Page 384 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 384

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
                                        UCSF, US  111         Prostate cancer      Office visit w/DRE every 3 mo, PSA every 3 mo (usually), TRUS         Implied that there was not a      Increase in Gleason or
                                        [18433013]              diagnosis, no         every 6-12 mo.                                                       specific protocol for             PSA velocity >0.75
                                                                prior therapy at   ≥2003: prostate biopsy every 12-24 mo                                   intervention; active              ng/mL/yr (also
                                        >1991                   another            ≥2002: “regular” nurse practitioner contact to ensure                   treatment based on                analyzed PSA
                                                                institution,          surveillance compliance and address concerns and anxiety             disease progression               velocity >2 ng/mL/yr
                                                                primary therapy                                                                                                              and PSA DT<2 yr.
                                                                AS or no                                                                                                                     Ultrasonography not
                                                                primary therapy                                                                                                              used (too much
                                                                (surgery,                                                                                                                    inter-observer
                                                                radiation,                                                                                                                   variability in lesion
                                                                brachytherapy,                                                                                                               size)
                                                                androgen                                                                                                                   Gleason upgrade to
                                                                ablation) within                                                                                                             ≥4 (if (≤6 at
                                                                6 mo of                                                                                                                      diagnosis) or ≥4+3
                                                                diagnosis                                                                                                                    (if 3+4 at diagnosis);
                                                              Patients                                                                                                                       PSADT ≤2 or 3
                                                                selectively were                                                                                                             yr 131
                                                                offered AS if                                                                                                              Gleason ≥7 or ≥33%
                                                                they met the                                                                                                                 of cores or >50% of
                                                                following                                                                                                                    any core 132
                                                                diagnostic
                                                                criteria: PSA
                                                                <10 ng/mL,
                                                                Gleason sum
                                                                ≤6, absence of
                                                                Gleason grade
                                                                4 or 5, cancer
                                                                involvement of
                                                                <33% of biopsy
                                                                cores, and
                                                                clinical T1/T2a
                                                                tumor
















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