Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer.

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Ann Intern Med. 2008 Mar 18;148(6):435-48. Epub 2008 Feb 4.
Erratum in:
Ann Intern Med. 2008 Jun 3;148(11):888.
Comment in:
Evid Based Med. 2008 Oct;13(5):139.

Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer.
Wilt TJ, MacDonald R, Rutks I, Shamliyan TA, Taylor BC, Kane RL.
of Minnesota School of Medicine, Minneapolis Veterans Affairs Center
for Chronic Disease Outcomes Research, Minneapolis, Minnesota 55417,

comparative effectiveness of localized prostate cancer treatments is
largely unknown. PURPOSE: To compare the effectiveness and harms of
treatments for localized prostate cancer. DATA SOURCES: MEDLINE
(through September 2007), the Cochrane Library (through Issue 3, 2007),
and the Cochrane Review Group in Prostate Diseases and Urologic
Malignancies registry (through November 2007).
Randomized, controlled trials (RCTs) published in any language and
observational studies published in English that evaluated treatments
and reported clinical or biochemical outcomes in localized prostate
cancer. DATA EXTRACTION: 2 researchers extracted information on study
design, sample characteristics, interventions, and outcomes.
18 RCTs and 473 observational studies met inclusion
criteria. One [one randomized controlled trial] [corrected] RCT
enrolled mostly men without prostate-specific antigen (PSA)-detected
disease and reported that, compared with watchful waiting, radical
prostatectomy reduced crude [corrected] all-cause mortality (24% vs.
30%; P = 0.04) and prostate cancer-specific mortality (10% [corrected]
vs. 15% [corrected]; P = 0.01) at 10 years [corrected] Effectiveness
was limited to men younger than age 65 years but was not associated
with Gleason score or baseline PSA level. An older, smaller trial found
no significant overall survival differences between radical
prostatectomy and watchful waiting (risk difference, 0% [95% CI, -19%
to 18%]). Radical prostatectomy reduced disease recurrence at 5 years
compared with external-beam radiation therapy in 1 small, older trial
(14% vs. 39%; risk difference, 21%; P = 0.04). No external-beam
radiation regimen was superior to another in reducing mortality. No
randomized trials evaluated primary androgen deprivation. Androgen
deprivation used adjuvant to radical prostatectomy did not improve
biochemical progression compared with radical prostatectomy alone (risk
difference, 0% [CI, -7% to 7%]). No randomized trial evaluated
brachytherapy, cryotherapy, robotic radical prostatectomy, or
photon-beam or intensity-modulated radiation therapy. Observational
studies showed wide and overlapping effectiveness estimates within and
between treatments. Adverse event definitions and severity varied
widely. The Prostate Cancer Outcomes Study reported that urinary
leakage (> or =1 event/d) was more common with radical prostatectomy
(35%) than with radiation therapy (12%) or androgen deprivation (11%).
Bowel urgency occurred more often with radiation (3%) or androgen
deprivation (3%) than with radical prostatectomy (1%). Erectile
dysfunction occurred frequently after all treatments (radical
prostatectomy, 58%; radiation therapy, 43%; androgen deprivation, 86%).
A higher risk score incorporating histologic grade, PSA level, and
tumor stage was associated with increased risk for disease progression
or recurrence regardless of treatment.
LIMITATIONS: Only 3 randomized
trials compared effectiveness between primary treatments. No trial
enrolled patients with prostate cancer primarily detected with PSA
testing. CONCLUSION: Assessment of the comparative effectiveness and
harms of localized prostate cancer treatments is difficult because of
limitations in the evidence.