Prostate cancer screening in the randomized Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial: mortality results after 13 years of follow-up.
BACKGROUND
The prostate component of the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial was undertaken to determine whether there is a reduction in prostate cancer mortality from screening using serum prostate-specific antigen (PSA) testing and digital rectal examination (DRE). Mortality after 7-10 years of follow-up has been reported previously. We report extended follow-up to 13 years after the trial.


METHODS
A total of 76 685 men, aged 55-74 years, were enrolled at 10 screening centers between November 1993 and July 2001 and randomly assigned to the intervention (organized screening of annual PSA testing for 6 years and annual DRE for 4 years; 38 340 men) and control (usual care, which sometimes included opportunistic screening; 38 345 men) arms. Screening was completed in October 2006. All incident prostate cancers and deaths from prostate cancer through 13 years of follow-up or through December 31, 2009, were ascertained. Relative risks (RRs) were estimated as the ratio of observed rates in the intervention and control arms, and 95% confidence intervals (CIs) were calculated assuming a Poisson distribution for the number of events. Poisson regression modeling was used to examine the interactions with respect to prostate cancer mortality between trial arm and age, comorbidity status, and pretrial PSA testing. All statistical tests were two-sided.


RESULTS
Approximately 92% of the study participants were followed to 10 years and 57% to 13 years. At 13 years, 4250 participants had been diagnosed with prostate cancer in the intervention arm compared with 3815 in the control arm. Cumulative incidence rates for prostate cancer in the intervention and control arms were 108.4 and 97.1 per 10 000 person-years, respectively, resulting in a relative increase of 12% in the intervention arm (RR = 1.12, 95% CI = 1.07 to 1.17). After 13 years of follow-up, the cumulative mortality rates from prostate cancer in the intervention and control arms were 3.7 and 3.4 deaths per 10 000 person-years, respectively, resulting in a non-statistically significant difference between the two arms (RR = 1.09, 95% CI = 0.87 to 1.36). No statistically significant interactions with respect to prostate cancer mortality were observed between trial arm and age (P(interaction) = .81), pretrial PSA testing (P(interaction) = .52), and comorbidity (P(interaction) = .68).


CONCLUSIONS
After 13 years of follow-up, there was no evidence of a mortality benefit for organized annual screening in the PLCO trial compared with opportunistic screening, which forms part of usual care, and there was no apparent interaction with age, baseline comorbidity, or pretrial PSA testing.
Division of Urologic Surgery, Washington University School of Medicine, St Louis, MO, USA.
Gerald L
GL
Andriole
E David
ED
Crawford
Robert L
RL
Grubb
Saundra S
SS
Buys
David
D
Chia
Timothy R
TR
Church
Mona N
MN
Fouad
Claudine
C
Isaacs
Paul A
PA
Kvale
Douglas J
DJ
Reding
Joel L
JL
Weissfeld
Lance A
LA
Yokochi
Barbara
B
O'Brien
Lawrence R
LR
Ragard
Jonathan D
JD
Clapp
Joshua M
JM
Rathmell
Thomas L
TL
Riley
Ann W
AW
Hsing
Grant
G
Izmirlian
Paul F
PF
Pinsky
Barnett S
BS
Kramer
Anthony B
AB
Miller
John K
JK
Gohagan
Philip C
PC
Prorok
D000367:Age Factors; D000368:Aged; D014408:Biomarkers, Tumor / Q000097:blood*; D015179:Colorectal Neoplasms / Q000175:diagnosis; D015897:Comorbidity; D051517:Digital Rectal Examination; D055088:Early Detection of Cancer; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D015994:Incidence; D008175:Lung Neoplasms / Q000175:diagnosis; D008297:Male; D008403:Mass Screening / Q000379:methods*; D008875:Middle Aged; D010051:Ovarian Neoplasms / Q000175:diagnosis; D016012:Poisson Distribution; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000276:immunology / Q000401:mortality*; D012306:Risk; D015996:Survival Rate
D014408:Biomarkers, Tumor; D017430:Prostate-Specific Antigen