Page 376 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
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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
                                        Royal Marsden         AS: Fitness for      WW: PSA and DRE every 6 mo                                            WW: Symptomatic prostate          NR
                                        Hospital, UK 112        RP, T1-2, N0/X,    AS: PSA and DRE every 3-6 mo for 2 yr, then every 6 mo.                 cancer progression
                                        [15839912]              M0/X, PSA≤20          Repeat Bx not routine. Repeat imaging only if clinically           AS: Rate of rise of PSA,
                                                                ng/mL, Gleason        indicated.                                                           according to judgment of
                                        1993-2002               ≤7. “Favorable                                                                             each patient and clinician.
                                                                prognostic
                                                                characteristics
                                                                and according
                                                                to patient
                                                                preference.”
                                                              WW: localized
                                                                prostate cancer
                                                                (any T stage,
                                                                N0/X, M0/X,
                                                                any PSA,
                                                                Gleason score
                                                                ≤7). Unsuitable
                                                                for RP typically
                                                                because
                                                                advanced age
                                                                or
                                                                comorbidities.
                                        Royal Mardsen         T1/2a, N0/X,         PSA monthly in yr 1, every 3 mo in yr 2, and every 6 mo               PSA DT<4 yr, histological         Gleason score >7,
                                        Hospital, UK 124        Mo/X, PSA<15          thereafter.                                                          progression (see Definition       primary Gleason
                                        [17850368]              ng/mL, Gleason     DRE every 3 mo for 2 yr.                                                of progression), or patient       ≥4, (initial Gleason
                                                                ≤7 (primary        TRUS-guided octant biopsy at 18-24 mo                                   preference, or PSA velocity       3+3, upgraded to
                                        ≥2002                   Gleason ≤3),                                                                               >1 ng/mL/yr  128                  Gleason ≥3+4)   136
                                                                cancer in                                                                                                                    or ≥50% biopsy
                                                                ≤50% of                                                                                                                      cores positive.
                                                                biopsy cores.
                                                                (Patients were
                                                                50-80 yr). Fit for
                                                                RP, Elected AS
                                                                for initial
                                                                treatment
                                        SPCG-4, Finland,      Patients with        Followup was done every 6 mo in the first 2 yr, then every 1 yr.      Adjuvant local or systemic        Local progression: a
                                        Sweden, and             newly                 Followup included: a clinical examination, measurement of            treatment was not given.          transcapsular tumor
                                        Iceland 144             diagnosed             hemoglobin, creatinine, PSA, and alkaline phosphatase                TURP was recommended              growth was




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