Page 495 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Appendix Table C4.2. Comparison between watchful waiting and radical prostatectomy (continued)
Author, Year Study name Comparison Outcome Followup Sample size Results Factors included in the
[Pubmed ID] /Database definition/ (yr) per group model
measurement
Study design instrument
Incidence of
distant
metastases
Bill-Axelson 213 SPCG-4 RP vs. WW Metastatic 12.8 yr RP: 347 RR=0.59 (0.45, 0.79); P None (RCT)
2011 lesions that WW: 348 <0.001
21542742 were visible on
a bone scan or
RCT histologically
confirmed soft-
tissue
metastases
outside the
pelvic area
Morbidity of
primary
treatment
Johansson 214 Ancillary RP vs. WW Physical Mean RP: 189 (166 Last 6 mo; 2-3 yr post NR (RCT)
2009 investigation symptoms followup: responders) randomization
18783877 from SPCG-4 (erectile 4.1 yr WW: 187 Erectile dysfunction: RR=2.2
trial dysfunction, (range: 1- (160 (1.5, 3.2)
RCT weak urinary 8) responders) Weak urinary stream:
stream, urinary [some of the RR=0.6 (0.4, 1.2)
leakage, fecal responders Urinary incontinence:
leakage) did not reply RR=3.7 (1.6, 8.5)
to all Fecal leakage: RR=0.3
questions] (0.04, 3.2)

Last 6 mo; 4-5 yr post
randomization
Erectile dysfunction: RR=1.8
(1.3, 2.6)
Weak urinary stream:
RR=0.7 (0.4, 1.2)
Urinary incontinence:
RR=1.7 (1.0, 2.8)

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