Page 86 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
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Table 5. Monitoring criteria in protocols with curative intent in chronological order of starting enrollment year (continued)
                                        Center, Country        Monitoring           Gleason      # biopsy cores       PSA       Imaging         Behavioral       Additional laboratory        Triggers for
                                        [Pubmed ID]            schedule             score        /% cores                                       indication       tests                        interventions
                                        Enrollment years
                                                                                                                                                                                                      i
                                        Toronto-SRCC,          Every 3 mo for       Histologic        Subsequent           PSA progression:  Bone scan           –              PAP and       Clinical,
                                        Canada  114,125,129,130    the first 2 yr and   progression:   biopsies were       PSA DT <2 yr,        annually for                    serum         histologic or
                                        [11395227;             every 6 mo           Gleason score     performed every      based on at least    the first 2 yr                  creatinine    PSA progression
                                        19917860;              thereafter           upgraded to       3-4 yr to identify   3 separate           and biennially                                triggered the
                                        20478589;                                   ≥8 in the         biologic             measurements         thereafter. If                                offer of
                                        20846681]                                   rebiopsy of the   progression. 125     over a minimum       PSA >15                                       treatment based
                                                                                    prostate at 18                         of 6 mo; final       ng/ml, annual                                 on age, extent of
                                        1995-2002 as a                              months post       Sextant biopsies     PSA >8 ng/ml; p-     bone scan                                     disease and
                                        phase II trial; 2003-                       enrollment        were used from       value <0.05 from     was                                           comorbidities.
                                        ongoing as an open                                            1995 to 2000;        regression of        performed.
                                        prospective cohort                                            since 2000, 10       ln(PSA) on time.
                                                                                                      to 14-core                                TRUS was
                                                                                                      biopsies were        Protocol changes  performed
                                                                                                      performed using      in PSA DT            every 6 mo.
                                                                                                      the Vienna           assessment or
                                                                                                      nomogram.   129      calculation in
                                                                                                                           1999 and after
                                                                                                                                 g
                                                                                                                           2002.  In 2005
                                                                                                                           the group
                                                                                                                           developed a
                                                                                                                           general linear
                                                                                                                           mixed model as
                                                                                                                           a clinical decision
                                                                                                                           making aid. h130
                                        Memorial Sloan-        Every 6 mo PSA       Gleason grade     >3 positive          >10                  –                –              –             Treatment was
                                        Kettering Cancer       and DRE; biopsy      4 or 5            biopsy cores                                                                            recommended
                                        Center, US 115         was within 12 to                       (minimum 10),                                                                           when the patient
                                        [21167529]             18 mo starting                         biopsy core                                                                             no longer met
                                                               AS and repeated                        containing >50%                                                                         study eligibility
                                        1997-2009              every 2 to 3 yr                        cancer                                                                                  criteria during
                                                                                                      involvement                                                                             followup.

















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