Physicians at MedStar Georgetown University Hospital and Georgetown University Medical Center, Washington, DC, are studying the safety and effectiveness of prostate artery embolization in men with enlarged prostate glands and urinary obstruction. According to the National Institutes of Health, benign prostatic hyperplasia occurs in more than half of men in their 60s and 90% of men in their 70s and 80s.
Symptoms of benign prostatic hyperplasia 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 benign prostatic hyperplasia include drug therapy, transurethral resection of the prostate, or removal of the prostate by way of an open abdominal operation, said Dr Spies. “We hope [prostate artery embolization] will be a less invasive, less drastic approach that will be safe and effective.”
About the Procedure
Prostate artery embolization is a nonsurgical, 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 2 hours or less,” said Dr. Spies, who is also Professor of Radiology at Georgetown University School of Medicine.
Studies 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 5 years after the procedure.”
Since 2001, Dr. Spies has pioneered uterine fibroid embolization in women and is considered an international expert in interventional radiology. In that procedure, the same kinds of tiny beads are used to block the blood supply to the fibroid, which causes it to shrink and die.
Enrollment Criteria
This is the first prostate artery embolization study authorized in the United States by the Food and Drug Administration under an Investigational Device Exemption and will allow the research team to study the safety and effectiveness of the treatment.
To participate in the study, patients must be at least 50 years of age but not older than 90, have had symptoms of benign prostatic hyperplasia for at least 6 months, and meet certain criteria for urine flow and size of the prostate gland. They cannot have had prior surgery for benign prostatic hyperplasia or have prostate cancer. Each patient will be screened for prostate cancer as a part of the protocol. ■
