nlargement of the prostate is a common part of a man's aging process.
The prostate gland is in a process of continual growth through most
of a man's adult life. Medical doctors refer to the condition of
having an enlarged prostate as benign prostatic hyperplasia
(BPH),
or benign prostatic hypertrophy. Though prostate enlargement is an
ongoing process, it does not usually present problems until late in
a man's life. Many of the problems that occur as a result of BPH
can be attributed to the obstruction of the urethra and loss of bladder
function, two conditions that are directly related to the enlargement
of the prostate. There are various symptoms of BPH, but the common
ones involve changes or problems with urination.
reatment options available to men who have BPH symptoms fall into three
general categories: surgical, non-surgical, and drug therapy. The U.S.
Food and Drug Administration (FDA) has approved four drugs for the treatment
of BPH. These drugs alleviate the symptoms of BPH by relieving the obstruction
of the urethra.
inasteride (
Proscar (R) ), a 5(alpha)-reductase inhibitor, was approved by
the FDA in 1992. Finasteride inhibits the production of hormones that causes
the enlargement of the prostate. Finasteride can also shrink the prostate in
some men.
hree other FDA-approved drugs belonging to the class of drugs known as
alpha-blockers relieve BPH symptoms by relaxing the smooth muscle of the
prostate and the bladder neck. Terazosin (Hytrin˙) was approved by the
FDA in 1993, doxazosin (
Cardura
(R) ) in 1995, and tamsulosin (Flomax˙) in 1997.
he Medical Therapy of Prostatic Symptoms (
MTOPS) is a multi-center clinical
trial designed to assess the long-term benefits of pharmacotherapy of BPH.
MTOPS is a double-masked, placebo-controlled randomized clinical trial designed
to evaluate the long-term efficacy of finasteride, or doxazosin, or the combination
of both, in delaying or preventing the clinical progression of symptomatic BPH.
MTOPS is the largest and longest study to test whether drug therapy can prevent
or delay the noncancerous growth of the prostate.
he George Washington University Biostatistics Center serves as the Biostatistical
Coordinating Center (BCC) of the MTOPS trial.
limited six-center randomized clinical trial was conducted during 1992-95 in
141 participants with symptomatic BPH to determine the feasibility of conducting
a full-scale trial. Upon successful completion of the feasibility phase, the
full-scale trial was initiated with 17 US clinical sites participating. From
December 1995 through March 1998, the 17 MTOPS clinics enrolled 2,931
participants with a diagnosis of symptomatic BPH.
articipants were randomized to one of four treatment groups: double-placebo, finasteride, doxazosin or the
combination of finasteride and doxazosin. A total of 3,047 participants
randomized during the pilot and full-scale phases are currently being
followed with quarterly visits. Follow-up phase of the full-scale trial
will continue until the end of November 2001. Closeout and analysis phase
will commence immediately after the last follow-up visit is completed
and is projected to last until the first quarter of the year 2002.
unique feature of MTOPS that has not been done in prior studies of
pharmacotherapy of BPH is the biopsy substudy. A total of 1,082 volunteers
from the 2,931 participants randomized during the full-scale phase are
currently participating in this substudy. Biopsies of the prostate will
be obtained on these volunteers at predetermined times during the course
of the trial to evaluate the status of the prostate at key event times.
The purpose of the substudy is to provide additional information regarding
the histopathobiology of BPH and to test existing biomarkers for their
prognostic ability regarding response to drug therapy.
unding for MTOPS (UO1-DK-46472; IND 43,564) is provided by the National
Institute of Diabetes and Digestive and Kidney Diseases (
NIDDK).
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