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Data show Dutasteride reduces Prostate
Cancer Diagnosis in men with increased risk
Newswise — Dutasteride (Avodart), a commonly
prescribed drug to treat benign prostatic
hyperplasia, has been shown to lower the
risk of prostate cancer by 23 percent in men
with an increased risk of the disease,
according to results of an international
clinical trial presented at the American
Urological Association (AUA) Annual Meeting
in Chicago.
Data from the REDUCE Trial is being
presented to members during the plenary
session, and lead investigator Gerald
Andriole, MD, of Washington University
School of Medicine in St. Louis, will hold a
special session for interested media at
12:15 p.m. in the AUA Press Suite.
The REDUCE trial is the first to examine
chemoprevention for prostate cancer in men
at increased risk for the disease.
The trial involved 8,200 men ages 50 – 75
who were randomly assigned to receive a
placebo or a daily 0.5 mg dose of
dutasteride.
Men in the study had elevated PSA levels
(2.5 – 10 ng/ml) indicating that they were
at increased risk of prostate cancer.
They had undergone biopsies that found no
evidence of cancer within six months prior
to enrolling in the trial.
Therefore these men either did not have
prostate cancer or possibly had microscopic
tumors that were too small to be detected by
the pre-study biopsy.
The investigators performed scheduled
biopsies on the men two years after they
enrolled in the study and again after four
years.
After two years, prostate cancer was found
in 17.2 percent of the men who took a
placebo, compared with 13.4 percent who took
dutasteride.
After four years, prostate cancer was
diagnosed in another 11.8 percent of men who
received a placebo and 9.1 percent who
received dutasteride.
"In these men, the most likely explanation
is that dutasteride worked by shrinking
tumors and/or slowing their growth, thereby
making them less likely to be detected by a
biopsy," Dr. Andriole said.
“This drug has the potential to offer many
thousands of men a way to reduce their risk
of being diagnosed with prostate cancer and,
as a result, more men could avoid treatment
for prostate cancer and the cost and
unwanted side effects associated with
treatment.”
The investigators found that there was no
greater risk for the men who did develop
prostate cancer to have aggressive tumors.
This outcome was closely watched because an
earlier trial of a similar BPH drug –
finasteride (Proscar) – produced
controversial results with regard to the
risk of more aggressive tumors in those men
who developed prostate cancer while on
finasteride.
An initial analysis of the finasteride data
suggested that there was an increased risk
for men to have prostate cancer with higher
Gleason scores but a later analysis
suggested that there is probably no greater
risk for these men to develop higher grade
prostate cancer.
Over the course of the current study, 6.8
percent of men in the placebo group and 6.7
percent of men in the dutasteride group were
found to have aggressive, high-grade tumors,
defined as a Gleason score of 7 – 10.
“We are very encouraged by this finding,”
Dr. Andriole says.
“Clearly, the data show dutasteride did not
lead to more high-grade tumors, even though
they would have been easier to detect in the
dutasteride-treated men due to their smaller
prostates.”
The REDUCE (Reduction by Dutasteride of
Prostate Cancer Events) trial was conducted
at 250 sites in 42 countries around the
world.
The
study was funded by GlaxoSmithKline. Dr.
Andriole is chairman of the REDUCE steering
committee and a consultant for the company.
About the American Urological Association:
Founded in 1902 and headquartered near
Baltimore, Maryland, the American Urological
Association is the pre-eminent professional
organization for urologists, with more than
16,000 members throughout the world.
An educational nonprofit organization, the
AUA pursues its mission of fostering the
highest standards of urologic care by
carrying out a wide variety of programs for
members and their patients.
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