Hackensack University Medical Center Urologists Offer Pioneering Clinical Trial to Study Nerve Recovery after Robotic Prostatectomy for Prostate Cancer

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Department of Urology uses bioregenerative medicine to improve erectile function and continence after robotic radical prostatectomy.

Hackensack Meridian Hackensack University Medical Center’s Department of Urology is among the first in the nation to embrace bioregenerative medicine as a new way to promote nerve regeneration and a faster return to normal erectile and urinary function after robot-assisted prostate cancer surgery.

To further advance the field of prostate cancer care, Hackensack University Medical Center urologists are now enrolling patients in a clinical trial studying the benefits of CLARIX CORD 1K® (CLARIX). CLARIX is a cryopreserved umbilical cord and amniotic membrane matrix that is applied during surgery to the nerves that control erectile function.

“At Hackensack University Medical Center, our goal is to provide our patients with the latest treatment options that promote improved outcomes,” said Mark Sparta, president and chief hospital executive, Hackensack University Medical Center. “Clinical trials allow our patients to access promising treatments before they are widely available.”

Promoting Improved Healing After Robotic Radical Prostatectomy

Hackensack University Medical Center urologists combine the latest technology with years of experience to perform multiport and single port robot-assisted radical prostatectomies to remove the entire prostate while preserving the nerves that control erectile function. However, despite these nerve-sparing techniques, a known side effect of robotic radical prostatectomy is nerve injury that may cause loss of or decrease in erectile function.

“CLARIX contains growth factors that minimize inflammation, reduce scar tissue formation, and promote nerve healing, all of which may contribute to a faster return of erectile function as well as urinary continence — two important measures of a patient’s quality of life after prostate cancer surgery,” said Ravi Munver, M.D., vice chairman and chief of Minimally Invasive & Robotic Urologic Surgery at Hackensack University Medical Center’s Department of Urology.

Bioregenerative matrices for restoring potency have shown encouraging results in early retrospective series — and some studies suggest that they may also result in a faster return to continence. However, many of these previous studies involved using thinner, dehydrated products that only contained amniotic tissue. CLARIX combines the umbilical cord with the standard amniotic membrane to more quickly deliver increased healing benefits.

“The CLARIX product we use is different than previously studied products and provides several advantages,” said Dr. Munver. “CLARIX is cryopreserved, thicker, moister, easier to apply, and persists longer at the surgical site. It also contains more cytokines, which are an important growth factor that contributes to nerve regeneration.”

CLARIX retains all of its natural structural and biological characteristics, but it does not include any living cells. That means that CLAIRX can be used safely without risk of infection or rejection.

Exploring the Potential of Bioregenerative Medicine

CLARIX, which is made by Amniox Medical Inc., is already used across a range of medical specialties, including ophthalmology, wound care, and neurosurgery. Hackensack University Medical Center urologists began using the product in 2015 because they saw its potential for improving quality of life for men who have had nerve-sparing surgery to treat prostate cancer.

“Quality of life after prostate cancer surgery is an important consideration for men, and our urological surgeons saw that CLARIX had the potential to help patients recover more quickly,” said Ihor S. Sawczuk, M.D., regional president, Northern Market, Hackensack Meridian Health.

Eager to learn more about how bioregenerative medicine could be used to support recovery after robot-assisted nerve-sparing radical prostatectomies, Dr. Munver began using CLARIX in carefully selected patients and maintained a retrospective database of patient outcomes.

In a retrospective study of 21 patients, Dr. Munver showed that men who received CLARIX experienced a faster return of erectile function after nerve-sparing robot-assisted prostatectomy than men who did not receive CLARIX at six months after surgery. Dr. Munver then presented an abstract detailing his findings at the World Congress of Endourology in 2018 and distinguished himself as among the first in the world to report data on this topic.

Backed by this encouraging retrospective data, Dr. Munver — along with Michael D. Stifelman, M.D., chair of Urology and director of Robotic Surgery at Hackensack University Medical Center and professor and founding chair of Urology at Hackensack Meridian School of Medicine, and urological surgeons Mutahar Ahmed, M.D., director of the Center for Bladder Cancer at Hackensack University Medical Center, and Gregory Lovallo, M.D. — initiated a prospective, single-blinded clinical trial that began on January 30, 2020.

“We are among the only institutions in the world that are prospectively looking at how we can use a bioregenerative matrix to improve quality-of-life outcomes after robot-assisted radical prostatectomy,” said Dr. Munver.

“If you have prostate cancer, are interested in surgery, and want to potentially improve your chances of restored erectile function and quicker return to urinary control after surgery, you may be a candidate for the CLARIX trial,” said Dr. Stifelman. “The first step is to come in and see us, and we will perform an evaluation to determine whether you meet the criteria.”

The clinical trial, officially named “Prospective, Controlled Study Evaluating Recovery of Potency and Continence Following Robot-Assisted Radical Prostatectomy with and without Cryopreserved Umbilical

Cord Allograft,” is open for ongoing enrollment. For more information, contact Helaine Koster, RN, CCRP, Research Nurse Coordinator, Department of Urology, at Helaine.Koster@hackensackmeridian.org.

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