MINNEAPOLIS/ST. PAUL (March 18, 2009) - Six annual screenings for prostate cancer led to more diagnoses of the disease, but not fewer prostate cancer deaths, according to a new major report from the Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial. The results appear online today in the New England Journal of Medicine (NEJM).

"What this report tells us is that the short-term benefits of prostate
cancer screening, using present methods, do not result in the reductions in
death that we had hoped," said Timothy R. Church, Ph.D., professor in the
University of Minnesota's School of Public Health and cancer researcher with
the University's Masonic Cancer Center.

Church is the principal investigator for the University of Minnesota's PLCO
trial site, which enrolled 17,099 men, making it the largest of 10 sites in
the United States. He also is a co-author on the NEJM article.

"It is possible that prostate cancer screening may produce longer-term
benefits, and we will continue to monitor men in this study with the hope
that we eventually will see reduced death from this disease," Church said.
"In the meantime, it is important to remember that men differ in their risks
for prostate cancer based on their family and personal history. Those men
who are concerned about their prostate health should consult with their
physicians about the best way to proceed."

The U.S. Preventive Services Task Force, whose recommendations are
considered the gold standard for clinical preventive services, recently
concluded that there is insufficient evidence to assess the balance of
benefits and harms for prostate cancer screening in men younger than age 75
and recommended against prostate cancer screening in men age 75 and older.

Church said it is too early to know whether these PLCO trial results will
alter the screening recommendations.

There were 76,693 men in this PLCO trial. Of the total study participants,
38,343 were randomly assigned to be offered annual screening with
prostate-specific antigen (PSA) tests for six rounds and digital rectal
physical exams (DRE) for the first four rounds. The other 38,350 men were
randomly assigned to usual-care and did not receive recommendations for or
against annual prostate cancer screening.

Of the men in the group who were offered annual screening, 85 percent had
PSA tests and 86 percent had DREs. Men in the screening group were referred
to their physician or health care provider for follow-up testing for
prostate cancer if their PSA level was greater than 4.0 nanograms per
milliliter (ng/mL) or if DRE found an abnormality.

 Men in the usual-care group sometimes had these tests as well, due to the
growing public acceptance of such screening. Screening by PSA in this
usual-care group increased from 40 percent at the beginning of the study to
52 percent of men by the last screening year, and screening with DRE ranged
from 41 percent initially to 46 percent by the last screening year.

The National Cancer Institute (NCI) began the PLCO trial in 1992 to provide
answers about the effectiveness of prostate, lung, colorectal, and ovarian
cancer screening tests in reducing deaths from these cancers. Christine
Berg, M.D., is the NCI leader of the PLCO trial and the senior author on
this report on prostate cancer screening.

The data are being made public now because the trial's Data and Safety
Monitoring Board, an independent review committee that meets every six
months, saw a continuing lack of evidence that screening reduces death due
to prostate cancer as well as clear evidence that screening causes men to be
treated unnecessarily. Today's results in the online NEJM coincide with
presentation of the data at the European Association of Urology meeting in
Stockholm, Sweden. (The print version of the results will appear in the
March 26, 2009 issue of NEJM.)

The online publication of the NEJM also contains a report from the large
European Randomized Study of Prostate Cancer (ERSPC), which shows a 20
percent reduction in the rate of death from prostate cancer but with a high
risk of overdiagnosis. In the ERSPC, unlike the PLCO trial, men were
referred for follow-up testing if their PSA level was 3.0 ng/mL or higher
and were also screened, on average, every four years as opposed to annually
PLCO.

In addition to Church and Berg, researchers on this study included Andriole
GL, Grubb RL, Buys SS, Chia D, Fouad MN, Gelmann, EP, Kvale PA, Reding DJ,
Weissfeld JL, Yokochi LA, Crawford ED, O'Brien B, Clapp JD, Rathmell JM,
Riley TL, Hayes RB, Kramer BS, Izmirlian G, Miller AB, Pinsky PF, Prorok PC,
and Gohagan JK.

More about this prostate cancer screening report

This report includes data for all participants seven years after they joined
the trial and for 67 percent of participants 10 years after they joined the
trial. Other important findings include:

* At seven years, 22 percent more prostate cancers were diagnosed in
the screening group (2,820 men vs. 2,322 in the usual-care group). This
excess is continuing to be observed in data collected up to 10 years
(currently a 17 percent excess, 3,452 men vs. 2,974 men). It has long been
suspected that many prostate cancers are never diagnosed and these findings
confirm that suspicion.
* The vast majority of men in both groups who developed prostate
cancer were diagnosed with relatively early stage II (out of IV stages, of
which IV is the late stage) disease, and the number of late-stage cases was
similar in the two groups. However, men in the usual-care group had more
prostate cancers that fell into the Gleason scoring system's 8 to 10 range,
which marks them as more aggressive. There is still some chance that the
smaller number of men with prostate cancer with a Gleason score of 8 to 10
in the intervention group will lead to a mortality difference between men in
the two groups, but data analyzed so far do not show any trend toward such a
difference. (The Gleason scoring system was developed by the late Donald
Gleason, M.D., a University of Minnesota Medical School faculty member.)
* Men in both groups who were diagnosed with prostate cancer at the
same stage received similar treatments for their disease. This reflects the
PLCO study design policy of not mandating specific therapies.
* At seven years, 50 deaths were attributed to prostate cancer in the
screening group and 44 deaths were in the usual-care group. Through year 10,
there were 92 prostate cancer deaths in the screening group and 82 in the
usual-care group. The difference between the numbers of deaths in the two
groups was not statistically significant. Thus there was no detectable
mortality benefit for screening vs. usual-care.

A Q & A on the prostate screening results from the PLCO is available at
http://www.cancer.gov/newscenter/pressreleases/PLCOprostateResultsQandA

Masonic Cancer Center, University of Minnesota is part of the Academic
Health Center. It is designated by the National Cancer Institute as a
comprehensive cancer center for cancer research, treatment, and education.
For more information, visit www.cancer.umn.edu or call 612-624-2620.

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