Page 344 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 344

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
                                        Dana-Farber           Clinically localized disease (T1c-   PSA and DRE every 6 mo, and 20-core biopsy            Patients with progression         Progression criteria: 1)
                                        Cancer Institute,       T2c), Gleason score 6 or less        every 12 to 18 mo                                     were offered surgery or           3 or more positive
                                        US 117                  with no pattern 4, <3 cores        Protocol with cure intent.                              radiotherapy.                     cores, 2) increased
                                        [21167525]              positive for cancer and no                                                                                                   grade (Gleason
                                                                more than 50% of cancer in                                                                                                   score 7 or greater)
                                        2000-2010               any core.                                                                                                                    and/or 3) more than
                                                              No age, PSA values or PSA                                                                                                      50% of any core
                                                                density exclusion criteria was                                                                                               involved with
                                                                used.                                                                                                                        cancer.
                                        Erasmus Univ.         Histologically       Usually followed clinically twice yearly (mean 2.7 annual visits,     Subjective progression, like      Local progression:
                                        hospital,               confirmed             range 1.4 to 4.3) for physical exam including DRE and serum          obstructive micturition or        symptomatic,
                                        Netherlands 145         cancer;               PSA and alkaline phosphatase levels. Bone scan and chest x-          pain, was considered for          increase in T
                                        [7544841]               Metastatic            ray were repeated regularly and when clinically indicated.           treatment decisions. 145          category, increase in
                                                                disease was        Follow-up regimens varied among local practices, data for this                                            prostate size on
                                        ≤1990; 1993-            excluded by a         study were collected from chart reviews of medical history,        Note: The authors reported          DRE by 25%, or
                                        2006 150                normal chest x-       DRE, dissemination studies, and PSA tests.   150                     that of 13 patients with          increase in
                                                                ray and a                                                                                  progression, 6 started            ultrasound
                                                                normal bone                                                                                treatment (5 for subjective       measured volume
                                                                scan.                                                                                      symptoms; 1 for objective         >40%.
                                                              The decision not                                                                             progression only). The          Metastatic
                                                                to treat was                                                                               authors also reported that        progression: new
                                                                made by the                                                                                PSA progression may               bone lesion.
                                                                urologist in                                                                               serve as a trigger point to
                                                                discussion with                                                                            treatment. 150
                                                                the patient and
                                                                his family, with
                                                                respect to
                                                                patient age,
                                                                general health,
                                                                clinical stage
                                                                and patient
                                                                preference. All
                                                                patients had
                                                                estimated
                                                                survival >1 yr.
                                                              Men on AS who
                                                                were detected
                                                                within the
                                                                screening




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