Evaluation of Erectile and Urinary Function following Radical Prostatectomy With and Without Cryopreserved Umbilical Cord Allograft for Patients with Localized Prostate Cancer, AMNIOX CORD Study
This phase III trial compares the effect of adding cryopreserved umbilical cord allograft (CLARIX CORD 1K [registered trademark]) to robot-assisted radical prostatectomy (RARP) to RARP alone in improving erectile and urinary functions after surgery in patients with prostate cancer that has not spread to other parts of the body (localized). RARP, a common surgery for prostate cancer, is the surgical removal of all of the prostate as well as some of the surrounding tissues, including lymph nodes, using robotic assistance which can be associated with better outcomes. Despite the advances in surgical techniques, such as robotic surgery, there remains a high incidence of urinary incontinence and erectile dysfunction after surgery. CLARIX CORD 1K is a human umbilical cord matrix product from donated human placental tissues following healthy, live, cesarean section, full-term births after evaluating donor eligibility and placenta suitability. These tissues have been shown to reduce inflammation and scarring and improve healing and may promote regenerative healing in the pelvic nerves (neuroplexus) that impact erectile and urinary function. Applying CLARIX CORD 1K to the nerves during a RARP may improve the return to sexual and urinary function after surgery.