Page 345 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
P. 345

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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