Page 392 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 392

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
                                        Watchful Waiting      Age <85 yr,          PSA every 3 mo.                                                       Developing progressive            NR
                                        Study, US 147           biopsy proven                                                                              disease or electing to
                                        [14501381]              prostate cancer                                                                            initiate cancer therapy
                                                                within 48 mo,
                                        1998-2003               PSA <50
                                                                ng/mL, have not
                                                                received any
                                                                therapy
                                                                including
                                                                surgery,
                                                                radiation,
                                                                hormone or
                                                                chemotherapy,
                                                                have not been
                                                                diagnosed with
                                                                metastatic
                                                                disease, at
                                                                least 3-yr life
                                                                expectancy, no
                                                                history of any
                                                                type of
                                                                malignancy
                                                                within the past
                                                                5 yr with the
                                                                exception of
                                                                non-melanoma
                                                                skin cancer,
                                                                liver and kidney
                                                                function within
                                                                1.5 x upper
                                                                range of
                                                                normal, not
                                                                taking > 50 ug
                                                                selenium/day
                                                                as supplement,
                                                                Gleason score
                                                                <8.







                                                                                                                        C-114
   387   388   389   390   391   392   393   394   395   396   397