Radical prostatectomy versus observation for localized prostate cancer.
BACKGROUND
The effectiveness of surgery versus observation for men with localized prostate cancer detected by means of prostate-specific antigen (PSA) testing is not known.


METHODS
From November 1994 through January 2002, we randomly assigned 731 men with localized prostate cancer (mean age, 67 years; median PSA value, 7.8 ng per milliliter) to radical prostatectomy or observation and followed them through January 2010. The primary outcome was all-cause mortality; the secondary outcome was prostate-cancer mortality.


RESULTS
During the median follow-up of 10.0 years, 171 of 364 men (47.0%) assigned to radical prostatectomy died, as compared with 183 of 367 (49.9%) assigned to observation (hazard ratio, 0.88; 95% confidence interval [CI], 0.71 to 1.08; P=0.22; absolute risk reduction, 2.9 percentage points). Among men assigned to radical prostatectomy, 21 (5.8%) died from prostate cancer or treatment, as compared with 31 men (8.4%) assigned to observation (hazard ratio, 0.63; 95% CI, 0.36 to 1.09; P=0.09; absolute risk reduction, 2.6 percentage points). The effect of treatment on all-cause and prostate-cancer mortality did not differ according to age, race, coexisting conditions, self-reported performance status, or histologic features of the tumor. Radical prostatectomy was associated with reduced all-cause mortality among men with a PSA value greater than 10 ng per milliliter (P=0.04 for interaction) and possibly among those with intermediate-risk or high-risk tumors (P=0.07 for interaction). Adverse events within 30 days after surgery occurred in 21.4% of men, including one death.


CONCLUSIONS
Among men with localized prostate cancer detected during the early era of PSA testing, radical prostatectomy did not significantly reduce all-cause or prostate-cancer mortality, as compared with observation, through at least 12 years of follow-up. Absolute differences were less than 3 percentage points. (Funded by the Department of Veterans Affairs Cooperative Studies Program and others; PIVOT ClinicalTrials.gov number, NCT00007644.).
Center for Chronic Disease Outcomes Research, Minneapolis Veterans Affairs (VA) Health Care System, and Section of General Medicine, University of Minnesota School of Medicine, Minneapolis, USA. tim.wilt@va.gov
Timothy J
TJ
Wilt
Michael K
MK
Brawer
Karen M
KM
Jones
Michael J
MJ
Barry
William J
WJ
Aronson
Steven
S
Fox
Jeffrey R
JR
Gingrich
John T
JT
Wei
Patricia
P
Gilhooly
B Mayer
BM
Grob
Imad
I
Nsouli
Padmini
P
Iyer
Ruben
R
Cartagena
Glenn
G
Snider
Claus
C
Roehrborn
Roohollah
R
Sharifi
William
W
Blank
Parikshit
P
Pandya
Gerald L
GL
Andriole
Daniel
D
Culkin
Thomas
T
Wheeler
D000368:Aged; D005500:Follow-Up Studies; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D061366:Numbers Needed To Treat; D011183:Postoperative Complications / Q000453:epidemiology; D011467:Prostate / Q000473:pathology / Q000601:surgery; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy / Q000401:mortality; D011471:Prostatic Neoplasms / Q000401:mortality* / Q000473:pathology / Q000601:surgery*; D057832:Watchful Waiting
D017430:Prostate-Specific Antigen