Page 471 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer
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Appendix Table C4.1. Descriptive characteristics of the randomized controlled trials and comparative cohort studies considered
relevant to KQ4 (continued)
Author, Year Study name Comparison Study Sample Inclusion criteria Population description: Quality
[Pubmed ID] /Database duration size (total) Age Comments
PSA (ng/mL)
Study design Tumor grade
Stage
Schapira 226 4 RP vs. RT vs. 3 and 12 113 (pre- ≥40 years of age, newly Age: 69 (45-85) yr C
2001 academically- expectant mo treatment) clinically localized prostate
11242319 affiliated management cancer (AJCC stage I or II). Median PSA (IQR) – Selection
Wisconsin 112 (3 mo) Exclusion criteria: Unable to RP: 7.6 (4.9-11.1) bias: 19%
Prospective hospitals, speak English, a clinical RT: 7.1 (4.9-12.3) eligible
cohort including 2 102 (1 yr) diagnosis of dementia, or unable EM: 7.9 (3.2-10.1) patients
VA Medical to verbally communicate. were not
Centers Dropouts: 6 patients died before Gleason score in RP, RT, and contacted
the end of the study due to EM groups, respectively- for a variety
complications from radiation 2-4: 30%, 16%, 23% of reasons;
proctitis and cystitis after 5-6: 49%, 51%, 54% dropout
prostate cancer treatment with 7: 19%, 29%, 8% rate 12%,
external beam radiation (n=1), 8-10: 3%, 4%, 15% 9%, 7% in
myocardial infarction (n=1), RP, RT,
bladder cancer (n=1), and TNM Stage: EM, T1, 55%; T2, and RM
undetermined causes (n=3). 45%. RP, T1, 55%; T2, 45%. group,
Other reasons for dropping out RT, T1, 43%; T2, 57% respectively
included geographic relocation
(n=4, development of a new an
serious illness (n=3),
progression of an underlying
comorbidity (n=1), and lost to
followup (n=7)
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