Page 470 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
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Appendix Table C4.1. Descriptive characteristics of the randomized controlled trials and comparative cohort studies considered
                                        relevant to KQ4 (continued)
                                        Author, Year      Study name       Comparison       Study          Sample          Inclusion criteria                  Population description:             Quality
                                        [Pubmed ID]       /Database                         duration       size (total)                                        Age                                 Comments
                                                                                                                                                               PSA (ng/mL)
                                        Study design                                                                                                           Tumor grade
                                                                                                                                                               Stage
                                        Schapira 226      4                RP vs. RT vs.    3 and 12       113 (pre-       ≥40 years of age, newly             Age: 69 (45-85) yr                  C
                                        2001              academically-    expectant        mo             treatment)      clinically localized prostate
                                        11242319          affiliated       management                                      cancer (AJCC stage I or II).        Median PSA (IQR) –                  Selection
                                                          Wisconsin                                        112 (3 mo)      Exclusion criteria: Unable to       RP: 7.6 (4.9-11.1)                  bias: 19%
                                        Prospective       hospitals,                                                       speak English, a clinical           RT: 7.1 (4.9-12.3)                  eligible
                                        cohort            including 2                                      102 (1 yr)      diagnosis of dementia, or unable  EM: 7.9 (3.2-10.1)                    patients
                                                          VA Medical                                                       to verbally communicate.                                                were not
                                                          Centers                                                          Dropouts: 6 patients died before    Gleason score in RP, RT, and        contacted
                                                                                                                           the end of the study due to         EM groups, respectively-            for a variety
                                                                                                                           complications from radiation        2-4: 30%, 16%, 23%                  of reasons;
                                                                                                                           proctitis and cystitis after        5-6: 49%, 51%, 54%                  dropout
                                                                                                                           prostate cancer treatment with      7: 19%, 29%, 8%                     rate 12%,
                                                                                                                           external beam radiation (n=1),      8-10: 3%, 4%, 15%                   9%, 7% in
                                                                                                                           myocardial infarction (n=1),                                            RP, RT,
                                                                                                                           bladder cancer (n=1), and           TNM Stage: EM, T1, 55%; T2,         and RM
                                                                                                                           undetermined causes (n=3).          45%. RP, T1, 55%; T2, 45%.          group,
                                                                                                                           Other reasons for dropping out      RT, T1, 43%; T2, 57%                respectively
                                                                                                                           included geographic relocation
                                                                                                                           (n=4, development of a new an
                                                                                                                           serious illness (n=3),
                                                                                                                           progression of an underlying
                                                                                                                           comorbidity (n=1), and lost to
                                                                                                                           followup (n=7)


























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