Page 454 - An Evidence Review of Active Surveillance in Men With Localized Prostate Cancer

Appendix Table C4.1. Descriptive characteristics of the randomized controlled trials and comparative cohort studies considered
relevant to KQ4

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
Randomized
studies –
clinical
outcomes
Bill-Axelson 213 SPCG-4 WW vs. RP 12.8 yr 695 Newly diagnosed prostate Age: 65 yr A
2011 cancer patients, younger than
21542742 75 years, with life expectancy Mean PSA: 13
>10 years, T0d-T2, WHO well-
RCT moderately differentiated Grade: WW, WHO 1, 47.7%;
tumors. WHO 2, 52.3%; unknown, 0%.
RP, WHO 1, 48.4%; WHO 2,
51.3%; unknown, 0.3%

Stage: WW, T1b, 14.4%; T1c,
10.9%; T2, 74.4%; unknown,
0.3%. RP, T1b, 9.5%; T1c,
12.4; T2, 77.8%; unknown,
0.3%
Johansson 214 Ancillary WW vs. RP Mean 376 (326 Newly diagnosed prostate Mean age (range): WW, 65 yr B
2009 investigation follow-up responders) cancer patients, younger than (51-74); RP, 64 yr (48-74);
18783877 from SPCG-4 4.1 yr 75 years, with life expectancy Swedish
trial (range: 1-8 >10 years, T0d-T2, WHO well- PSA: NR component
RCT yr) moderately differentiated of SPCG-4
tumors, PSA<50 ng/ml, negative Grade: WW, WHO 1, 47%;
bone scan, health status that WHO 2, 53%, unknown, 0%.
would permit RP, life RP, WHO 1, 46%; WHO 2,
expectancy of >10 yr. 53%, unknown, 1%

Stage: WW, T0, 14%; T1, 24%,
T2, 60%; unknown, 2%. RP,
T0, 12%; T1, 21%; T2, 61%;
unknown, 5%

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