Page 378 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 378

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
                                        [12226148]              localized             levels.                                                              as a treatment for local          palpable; symptoms
                                                                prostate cancer,  A bone scan and chest radiograph were obtained every 1 yr                progression.                      of obstruction of the
                                        1989-1999               < 75 yr, with life    after start of the study. After 1996, chest x-ray films were                                           flow of urine that
                                                                expectancy of         obtained annually for the first 2 yr.                                                                  necessitated
                                                                >10 yr, T stage    Rebiopsy was not routinely undertaken.   152                                                              intervention, or both.
                                                                of T0d, T1 or
                                                                T2, eligible for
                                                                radical
                                                                prostatectomy,
                                                                well
                                                                differentiated to
                                                                moderately well
                                                                differentiated
                                                                tumor, negative
                                                                bone scan, PSA
                                                                level < 50
                                                                ng/mL.
                                                              After 1994, men
                                                                with T1c tumors
                                                                — according to
                                                                the revised
                                                                1987
                                                                International
                                                                Union against
                                                                Cancer
                                                                classification —
                                                                were also
                                                                eligible.
                                                              Men with a poorly
                                                                differentiated
                                                                tumor were not
                                                                eligible.
                                                                Patients whose
                                                                condition was
                                                                diagnosed with
                                                                an extended
                                                                biopsy protocol
                                                                were accepted
                                                                if <25% of the




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