Mortality results from a randomized prostate-cancer screening trial.
BACKGROUND
The effect of screening with prostate-specific-antigen (PSA) testing and digital rectal examination on the rate of death from prostate cancer is unknown. This is the first report from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial on prostate-cancer mortality.


METHODS
From 1993 through 2001, we randomly assigned 76,693 men at 10 U.S. study centers to receive either annual screening (38,343 subjects) or usual care as the control (38,350 subjects). Men in the screening group were offered annual PSA testing for 6 years and digital rectal examination for 4 years. The subjects and health care providers received the results and decided on the type of follow-up evaluation. Usual care sometimes included screening, as some organizations have recommended. The numbers of all cancers and deaths and causes of death were ascertained.


RESULTS
In the screening group, rates of compliance were 85% for PSA testing and 86% for digital rectal examination. Rates of screening in the control group increased from 40% in the first year to 52% in the sixth year for PSA testing and ranged from 41 to 46% for digital rectal examination. After 7 years of follow-up, the incidence of prostate cancer per 10,000 person-years was 116 (2820 cancers) in the screening group and 95 (2322 cancers) in the control group (rate ratio, 1.22; 95% confidence interval [CI], 1.16 to 1.29). The incidence of death per 10,000 person-years was 2.0 (50 deaths) in the screening group and 1.7 (44 deaths) in the control group (rate ratio, 1.13; 95% CI, 0.75 to 1.70). The data at 10 years were 67% complete and consistent with these overall findings.


CONCLUSIONS
After 7 to 10 years of follow-up, the rate of death from prostate cancer was very low and did not differ significantly between the two study groups. (ClinicalTrials.gov number, NCT00002540.)
Andriole
Gerald L
GL
Washington University School of Medicine, St. Louis, USA.
Crawford
E David
ED
Grubb
Robert L
RL
Buys
Saundra S
SS
Chia
David
D
Church
Timothy R
TR
Fouad
Mona N
MN
Gelmann
Edward P
EP
Kvale
Paul A
PA
Reding
Douglas J
DJ
Weissfeld
Joel L
JL
Yokochi
Lance A
LA
O'Brien
Barbara
B
Clapp
Jonathan D
JD
Rathmell
Joshua M
JM
Riley
Thomas L
TL
Hayes
Richard B
RB
Kramer
Barnett S
BS
Izmirlian
Grant
G
Miller
Anthony B
AB
Pinsky
Paul F
PF
Prorok
Philip C
PC
Gohagan
John K
JK
Berg
Christine D
CD
D000368:Aged; D051517:Digital Rectal Examination / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008297:Male; D008403:Mass Screening / Q000009:adverse effects; D008875:Middle Aged; D010349:Patient Compliance; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000175:diagnosis / Q000453:epidemiology / Q000401:mortality*; D014481:United States / Q000453:epidemiology
D017430:Prostate-Specific Antigen