Miller School Researchers to Study New Treatment for Benign Prostatic Hyperplasia

The Miller School of Medicine has been awarded a grant of $470,000 to be part of a multicenter clinical trial to evaluate an emerging treatment option for benign prostatic hyperplasia (BPH), an enlarged prostate, which affects more than 50 percent of men over age 50. With this approval from the Food and Drug Administration, the University of Miami will be one of just ten sites in the nation and the second site in South Florida.

The procedure, prostate artery embolization (PAE), employs a catheter that is inserted in the upper thigh. Using an x-ray, the catheter is guided to the vasculature of the prostate, where tiny beads are injected that temporarily block the blood supply to the prostate gland. With blood supply curbed, the prostate shrinks in size, relieving the symptoms of BPH such as slow or weak urinary stream, urgency and frequent urination.

Shivank Bhatia, M.D., assistant professor of radiology, is the principal investigator of the trial being conducted at both the Miller School and the Miami VA Healthcare System. “With BPH affecting so many men, having another option that is minimally invasive is a real benefit to patients,” Bhatia said. “With this study, we’ll be able to determine if PAE can become part of our treatment plan.”

Patients enrolled in the trial will be randomized to compare the results of PAE to the current standard of care, a surgical procedure known as a trans-urethral resection of prostate (TURP). However, surgical procedures involving an enlarged prostate are often invasive and can be associated with complications, including sexual dysfunction or urinary incontinence.

“The PAE study under Dr. Bhatia’s leadership has the potential to revolutionize treatment in this subgroup of men,” said Dipen Parekh, M.D., professor and Victor A. Politano Endowed Chair in Urology. “Shrinking the prostate size in the least invasive manner while significantly reducing treatment-related issues would be a big step for these patients.”

The trial involves close collaboration between urologists and interventional radiologists who will work together to screen patients for the study. In addition to Bhatia and Parekh, co-investigators of the study include Bruce Kava, M.D., associate professor of urology, Christopher Gomez, M.D., assistant professor of urology, Sanoj Punnen, M.D., assistant professor of urology, Mark Gonzalgo, M.D., Ph.D., professor of urology, Murugesan Manoharan, M.D., professor of urology, and Ramgopal Satyanarayana, M.D., associate professor of urology. Govindarajan Narayanan, M.D., associate professor of radiology and Chief of Interventional Radiology, and Mohamed Issam Kably, M.D., assistant professor of radiology, round out the team.

Bhatia and Kably trained in performing the PAE procedure in Brazil, with Francisco Carnevale, M.D., Ph.D., professor and chief of interventional radiology at the University of Sao Paulo, Medical School in Brazil, who is the principal investigator of the study, which is funded by Merit Medical System, Inc.

While great strides have been made in developing minimally invasive treatment options for this group of patients, Kava said, “Many of our patients are elderly, suffer from significant co-morbidities, have enormous prostate glands, and may not be able to tolerate the attendant risks associated with anesthesia. PAE offers these men a potential significant improvement in voiding symptoms, urinary flow rates, and overall quality of life.”

Patients will have follow up for five years to evaluate long term comparative effects of both treatment modalities. “This trial will enable us to introduce an alternative treatment option for the patients with an enlarged symptomatic prostate,” said Bhatia. “But it needs to be studied in more detail before it can be adopted as an approved mainstream alternative for management of BPH. Being one of only two sites for this trial in South Florida demonstrates that the Miller School of Medicine is on the cutting edge of clinical care.”

Narayanan said it is exciting to offer and study a minimally invasive treatment option in the sub-group of BPH patients who do not qualify or have failed traditional therapies, and is another example of the multidisciplinary collaboration at the University of Miami. “This study places us as one of the leaders in studying the latest treatment options that can have a significant impact in the management of BPH.”

To learn more about the clinical trial, call Clara Morales at 305-243-3404, or Dr. Bhatia at 305-243-4917 or 305-979-9602.

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