Page 386 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 386

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
                                        Univ. of              Patients who         WW: no additional information.                                        Increase in tumor volume          NR
                                        Connecticut             elected WW or      Patients on AS were followed with PSA on an average of every            (increased number or
                                        Health Center,          AS program.           6 mo. If PSA trending upward, the checks increased to every          percent of cores positive),
                                        US 108                  Men on WW             3 mo depending on initial presentation and PSA trend.                progression in Gleason
                                        [18707696]              were generally        Rebiopsies recommended 2 yr after initial biopsy or if an            score, onset of urinary
                                                                older with            increased in PSA >0.75 ng/dl, a change in DRE or at patient          symptoms, change in DRE
                                        1990-2006               localized             request.                                                             or patient request for
                                                                prostate cancer                                                                            definitive treatment due to
                                                                who did not                                                                                anxiety related to
                                                                desire                                                                                     increasing PSA trend.
                                                                aggressive
                                                                intervention.
                                                                Men on AS
                                                                were generally
                                                                younger with
                                                                low-risk
                                                                disease.
                                        Univ. of Florida,     Low-stage, low-      Patients are followed every 3 mo with PSA and DRE annually.           Cancer progresses or              NR
                                        US 149                  grade disease         Repeat biopsy about 6 mo after the initial diagnosis.                symptoms become
                                        [18263992]              (minimal                                                                                   imminent.
                                                                disease on
                                        2003-2006               biopsy), severe
                                                                medical
                                                                condition with a
                                                                life expectancy
                                                                of <10 yr, and
                                                                patient’s desire.
                                        Univ. of Miami,       Patients with        DRE and PSA every 3-4 mo for 2 yr and every 6 mo                      Disease progression  110          Local stage
                                        US 110                  clinically            subsequently.                                                      Treatment is encouraged at          progression
                                        [17850361]              localized          After 2000, a laterally directed and peripherally targeted TRUS         an increase in tumor              detected by DRE
                                                                prostate cancer       biopsy of 10-12 cores was performed 9-12 mo after the first          volume, Gleason score             and/or biochemical
                                        1991-2007               who elected for       rebiopsy, and then every yr or earlier if there was a dramatic       ≥7, or the presence of >2         progression (PSA
                                                                watchful waiting      rise in PSA or a change on DRE.                                      positive cores.                   increase 25-50 %/yr)
                                                                and to be                                                                                                                    or systemic
                                                                treated only                                                                                                                 progression when
                                                                when disease                                                                                                                 metastases
                                                                progressed. 127                                                                                                              detected. 110
                                                              No strict
                                                                guidelines for




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