A new trial is exploring whether CLARIX CORD 1K, a cryopreserved umbilical cord allograft, can contribute to a faster return of erectile function and urinary continence after robot-assisted radical prostatectomy.
Patient enrollment has begun in a new trial exploring whether CLARIX CORD 1K, a cryopreserved umbilical cord (UC) allograft, can improve continence recovery following robot-assisted radical prostatectomy (RARP).1
Patients on the trial are being randomized to RARP with or without use of CLARIX during surgery. The study is being conducted at Hackensack Meridian Hackensack University Medical Center in New Jersey.
“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,” study investigator Ravi Munver, MD, vice chairman and chief of Minimally Invasive & Robotic Urologic Surgery at Hackensack University Medical Center’s Department of Urology, stated in a press release.
“The CLARIX product we use is different than previously studied products and provides several advantages,” added 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.
The prospective randomized trial (NCT04263025) has a recruitment goal of 100 patients aged 30 to 70 years old who are scheduled to undergo bilateral, nerve sparing RARP.2 Patients’ tumors must be confined to the prostate and patients cannot have erectile dysfunction (IIEF-6 score ≥26). Patients cannot enroll in the trial if they have received pelvic radiation, a simple prostatectomy or transurethral prostate surgery, or systemic therapy for bladder cancer.
The foundation for launching the prospective randomized trial came from retrospective data showing (UC) allograft to be safe and effective when used with RARP. A retrospective study published in the Journal of Robotic Surgery assessed data for 200 patients who received bilateral, nerve-sparing RARP with or without CLARIX (100 in each group) at Hackensack Meridian Health Hackensack University Medical Center.3
The continence rates were significantly higher with RARP/UC versus RARP alone at 1 month (65% vs 44%; P = .018), 3 months (83% vs 70%; P = .03), and 12 months (97% vs 87%; P = .009). Biochemical failure occurred in 2 versus 4 patients in the UC versus RARP-alone groups, respectively.
The addition of CLARIX was particularly beneficial among subgroups at high risk for post-RARP incontinence, including older (aged ≥60 years) and obese patients. The investigators reported that no complication or adverse events related to CLARIX occurred.
“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,” Ihor S. Sawczuk, MD, regional president, Northern Market, Hackensack Meridian Health, stated in the press release.
1. Hackensack University Medical Center Urologists Offer Pioneering Clinical Trial to Study Nerve Recovery after Robotic Prostatectomy for Prostate Cancer. Hackensack Meridian Health. Published online October 6, 2020. https://bit.ly/35FY6MU. Accessed October 29, 2020.
2. AMNIOX CORD Study - Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft. NIH US National Library of Medicine ClinicalTrials.gov. Posted online February 10, 2020. https://clinicaltrials.gov/ct2/show/NCT04263025. Last updated February 11, 2020.
3. Ahmed M, Esposito M, Lovallo G. A single-center, retrospective review of robot-assisted laparoscopic prostatectomy with and without cryopreserved umbilical cord allograft in improving continence recovery. J Robot Surg. 2020; 14(2): 283-289. doi: 10.1007/s11701-019-00972-9