Georgetown is First and Only U.S. Center to Study Non-Surgical, Minimally Invasive Approach to Treat Enlarged Prostate


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[STK]

[IN] HEA MTC

[SU] TRI

-- WITH PHOTO -- TO HEALTH, MEDICAL, AND NATIONAL EDITORS:

Prostate Embolization Studied at Georgetown for Most Common Prostate

Problem in Men

WASHINGTON, March 13, 2014 /PRNewswire-USNewswire/ -- Physicians at

MedStar Georgetown University Hospital and Georgetown University

Medical Center have just begun to study the safety and effectiveness

of prostate artery embolization (PAE) in men with enlarged prostate

glands and urinary obstruction. The condition is called benign

prostatic hyperplasia or BPH and, according to the National Institutes

of Health, occurs in more than half of men in their 60s and 90 percent

of men in their 70s and 80s.

Symptoms of BPH include difficulty urinating, more frequent and urgent

urination, especially at night and a weak urine flow. "While the

condition is not cancer and is not life-threatening, the symptoms can

be very severe and substantially affect a man's quality of life," said

James Spies, MD, principal investigator of the study and chair of

Radiology at MedStar Georgetown. "Because so many men are affected by

this condition, the potential impact of an effective

minimally-invasive treatment could be substantial."

Alternatives to treating BPH include drug therapy or partial removal

of the prostate through the urethra in the penis, called a TURP

procedure or removal of the prostate by way of an open abdominal

operation," said Dr Spies. "We hope PAE will be a less invasive, less

drastic approach that will be safe and effective."

Prostate artery embolization is a non-surgical, minimally invasive

procedure that injects small beads into the arteries surrounding the

prostate. The beads block the prostate's blood supply and the prostate

begins to shrivel and shrink. The patient stays in the hospital for

one night and can usually return to regular activities within several

days.

"We go in through the artery at the top of the leg and the procedure

usually takes two hours or less," said Dr. Spies, who also is a

professor of Radiology at Georgetown University School of Medicine.

Sixty-eight year old Ron Simmons of Woodstock, Virginia is one of the

first to enroll in this study and have the procedure. "My biggest

problem has been trying to urinate in the morning. It's not a life

threatening problem but I'm miserable. I'm on the maximum dosage of

the prescription I take for this and I'm just hoping for some relief.

I've also researched the side effects of some of the other treatments

out there and I was concerned about the potential problems."

Studies that have been conducted in other countries suggest the

procedure is effective in most men and that injuries to other

structures are rare.

"This procedure does carry some potential risks," said Dr. Spies.

"This study will focus on the safety of the procedure, particularly to

make sure there are no injuries to the bladder or rectum which are

very close to the prostate. The study will also measure the severity

of symptoms before and for five years after the procedure."

Since 2001, Dr. Spies has pioneered fibroid embolization in women and

is considered an international expert in interventional radiology. In

that procedure, called Uterine Fibroid Embolization (UFE), the same

kinds of tiny beads are used to block the blood supply to the fibroid

which causes it to shrink and die.

This is the first PAE study authorized in the U.S. by the FDA under an

Investigational Device Exemption and will allow the research team to

study the safety and effectiveness of the treatment. PAE is still

considered investigational in the United States.

Because this is a clinical study, there are certain criteria that are

required for participation and some conditions that might exclude a

patient from taking part. In general, patients must be at least 50

years of age but not older than 90, have had symptoms of BPH for at

least six months, and meet certain criteria for urine flow and size of

the prostate gland. They cannot have had prior surgery for BPH or have

prostate cancer. Each patient will be screened for prostate cancer as

a part of the protocol.

About two weeks after his PAE procedure Ron Simmons said he was

feeling positive about his experience. "I feel like my symptoms have

improved and I'm interested to see how much my prostate might shrink

over the next year."

A full list of requirements can be found at:

http://clinicaltrials.gov/ct2/show/NCT01924988?term=prostate+embolization&rank=1

To be considered for the PAE study please call 202-444-6825.

Photo - http://photos.prnewswire.com/prnh/20140313/DC81801

SOURCE MedStar Georgetown University Hospital

-0- 03/13/2014

/CONTACT: Marianne Worley, 703-558-1287, worleym@gunet.georgetown.edu

/Photo: http://photos.prnewswire.com/prnh/20140313/DC81801

PRN Photo Desk, photodesk@prnewswire.com

/Web Site: https://www.medstarhealth.org

CO: MedStar Georgetown University Hospital

ST: District of Columbia

IN: HEA MTC

SU: TRI

PRN

-- DC81801 --

0000 03/13/2014 13:20:00 EDT http://www.prnewswire.com

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