Page 390 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 390

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
                                                                stage ≤T2 and
                                                                age ≤80 yr.
                                        Univ. of North        Patients with        PSA was monitored at 3 mo, then every 6 mo. Hematocrit and            NR                                Development of
                                        Carolina, US 155      stage T1c            creatinine were measured every 6 mo.                                                                    palpable disease in
                                                              prostate cancer                                                                                                              DER, gross hematuria,
                                        1991-1996             who chose to be                                                                                                              urinary tract infection,
                                                              on expectant                                                                                                                 bothersome symptoms
                                                              management. All                                                                                                              due to bladder outlet
                                                              patients had DRE                                                                                                             obstruction, metastatic
                                                              enzymatic PAP                                                                                                                disease as shown in
                                                              values obtained                                                                                                              physical examination
                                                              prior to or at least                                                                                                         or radiographic
                                                              4 wk after                                                                                                                   examination, PSA
                                                              prostatic biopsy,                                                                                                            level increase in 3
                                                              radionuclide bone                                                                                                            consecutive
                                                              scan, and                                                                                                                    measurements and
                                                              the absence of a                                                                                                             the total increase was
                                                              visible lesion upon                                                                                                          > 5 ng/ml.
                                                              transrectal US
                                                              that was proven
                                                              malignant
                                                              histologically.
































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