July 6, 2005: Due to low participant enrollment, the MIST Consortium
for Benign Prostatic Hyperplasia (BPH) today terminated the clinical
trial described in this news release. Only 50 men joined during
the first year of recruitment; approximately 350 men should have
been enrolled in that time. Many potential candidates did not want
to be randomly assigned to one of the treatment groups. NIDDK deeply
appreciates the commitment of the consortium's staff and the men
who joined the trial. MIST investigators have designed and launched
a new clinical research trial for BPH, described at http://clinicaltrials.gov/ct/show/NCT00451191?order=1.
NIH Launches New Study to Compare Prostate Surgery
Bethesda, Maryland The Minimally Invasive Surgical
Therapies (MIST) Consortium for Benign Prostatic Hyperplasia (BPH)
has launched a new study to compare long-term benefits and risks
of transurethral needle ablation (TUNA) and transurethral microwave
thermotherapy (TUMT) to a regimen of the alpha-1 inhibitor alfuzosin
and the 5-alpha reductase inhibitor finasteride. The National Institute
of Diabetes and Digestive and Kidney Diseases at NIH, part of the
Department of Health and Human Services, is investing more than
$15 million in the study.
TUNA and TUMT use heat to destroy part of the enlarged prostate
to improve urine flow and symptoms. Early studies suggest that
these procedures reduce the occurrence of erection or bladder control
side effects, which occur more often with the traditional surgery
for BPH, known as transurethral resection of the prostate (TURP).
TUNA and TUMT are said to be minimally invasive in part because
they typically are done with local anesthesia and men go home the
same day, whereas TURP requires general anesthesia and an overnight
hospital stay. As for drug therapy, a recently published large
randomized study showed that a regimen of finasteride (Proscar)
and the alpha-1 inhibitor doxazosin (Cardura) prevents progression
of BPH in a significant percentage of symptomatic men and it helps
men at high risk avoid surgery.
“It’s easy to see why drug therapy, TUNA and TUMT
have been embraced by many urologists and patients,” said
Leroy M. Nyberg Jr., Ph.D., M.D., director of NIDDK’s urology
trials. “Yet, we don’t know which treatment is more
effective in the long run and, for the most part, who would be
better served by the drug combination versus one of the minimally
By July 2006, researchers plan to have recruited and randomly
assigned more than 700 men with moderate to severe symptoms and
no prior prostate surgery to one of the three MIST therapies. The
men, age 50 and over, will be followed closely for 3 to 5 years,
until about July 2009, to see who develops urinary retention, urinary
tract infection or unacceptable incontinence after treatment; who
needs more treatment; and whose symptoms don’t improve by
at least 30 percent after treatment.
Consortium members recruiting patients are Baylor College of Medicine
in Houston; Columbia University in New York City; Mayo Clinic in
Rochester, Minn.; Medical College of Wisconsin in Milwaukee; Northwestern
University in Chicago; University of Colorado Health Sciences Center
in Denver; and the University of Texas Southwestern Medical Center
in Dallas. George Washington University Biostatistics Center in
Rockville, MD, provides overall coordination for the study and
data collection and analysis. For contact information visit www.mistbph.org.
BPH is increasingly common after age 50. Mild symptoms may wax
and wane on their own, but Nyberg predicts that as more Baby Boomers
cross into their 50s, physicians are likely to start seeing more
men who are up frequently at night using the bathroom, a typical
symptom of BPH along with embarrassing episodes of needing to go
right away (urgency), daytime frequency, and occasional episodes
of unavoidable wetting. Over time, the progressive symptoms associated
with BPH can have a significant impact on quality of life for the
individual as well as his close family members.
In 2000, BPH accounted for about 8 million office visits, 117,000
trips to emergency rooms, 105,000 hospital stays and 87,400 TURPs.
BPH also cost patients and insurers about $1.1 billion, without
considering nutritional supplements and 2.2 million prescriptions,
according to NIDDK’s Urologic Diseases in America interim
compendium, released this spring.
MIST will also compare TUNA to TUMT and seeks to identify men
best suited for each of the three therapies. Changes in sexual
function, ejaculation, bladder changes, PSA, prostate size and
shape, and ratio of various prostate tissues; and pain before,
during and after surgery, among other parameters, will be tracked
in search of characteristics predicting likely outcome and effectiveness
“Having a protocol to fit the man to the therapy without
having to try each treatment along the way should translate into
lower costs and more-satisfied patients,” said John W. Kusek,
Ph.D., a clinical trials expert at NIDDK.
MIST therapies are approved by FDA, but relative benefits, risks
and cost have never been compared. Further, there have been few
rigorously conducted randomized trials of the minimally invasive
“Previous studies of TUMT and TUNA haven’t looked
at side-effects and symptom relief long-term but, after we’ve
finished MIST, men and their doctors should be a lot smarter about
the options,” said Kusek.
Other support for MIST comes from Diagnostic Ultrasound, Bothell,
Washington; Urologix Inc. and Medtronic, both in Minneapolis; Merck & Co.,
Whitehouse Station, New Jersey; and Sanofi-Synthelabo Inc., New