This phase II trial studies the effect of human amnion membrane allograft in allowing an earlier recovery of erectile function and urinary control after robot-assisted surgery to remove the prostate (radical prostatectomy) in patients with prostate cancer that has not spread to other parts of the body (localized). Radical prostatectomy provides excellent cancer control, but may come at a cost to quality-of-life. This surgery can impact erectile function resulting in a decrease in sexual function and loss of urinary control resulting in leakage of urine. These side effects are mainly caused by injury to the nerves that control erections during surgery. Although there may be some improvement in erectile function over time, this takes several months to years and most likely never returns to normal levels. Dehydrated human amnion chorion membrane (dHACM) is made from membranes removed from placentas. Previous research suggests that the placement of dHACM during a radical prostatectomy may promote an earlier return of erectile function and urinary control. The theory is that these membranes have biological chemicals that have been shown to improve wound healing and may allow a faster recovery of nerve tissue that may be injured during surgery.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05842057.
PRIMARY OBJECTIVE:
I. To determine whether the use of a dHACM allograft improves erectile function recovery after radical prostatectomy as measured by Expanded Prostate Cancer Index Composite-Short Form (EPIC26) compared to a control group with no allograft.
SECONDARY OBJECTIVES:
I. To determine whether the use of a dHACM allograft improves erectile function recovery as measured by Sexual Health Inventory for Men (SHIM) compared to a control group with no allograft at 12 months post-robot-assisted radical prostatectomy (RARP).
II. To compare the two groups with respect to the proportion of men with mild erectile dysfunction (ED) or better based on EPIC26 and SHIM at 3, 6, 9, and 12 months post-RARP.
III. To compare the two groups with respect to the proportion of men who are able to achieve erections adequate for penetration 50+% of the time.
IV. To evaluate the proportion of men in each group who require the use of more invasive erectile aids (intracavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post-RARP.
V. To compare the two groups with respect to the rate of urinary control at 3, 6, 9, and 12 months (EPIC26 question 3).
VI. To compare the two groups with respect to the rate of biochemical failure as measured by a prostate specific antigen (PSA) > 0.2 ng/ml on two consecutives samples at 3, 6, 9, and 12 months.
VII. To compare the two groups with respect to the rates of adverse events (AEs) categorized by type and severity using Clavien-Dindo grading.
EXPLORATORY OBJECTIVE:
I. Blood and urine samples will be collected to facilitate future biomarker discovery and validation for oncologic and functional outcomes post-radical prostatectomy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP 1: Patients undergo placement of dHACM after completion of standard of care (SOC) RARP procedure. Patients also undergo collection of blood samples throughout the trial.
GROUP 2: Patients undergo SOC RARP procedure without placement of dHACM. Patients also undergo collection of blood samples throughout the trial.
After completion of study intervention, patients are followed up at 3, 6, 9, and 12 months.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationUniversity of Miami Miller School of Medicine-Sylvester Cancer Center
Principal InvestigatorSanoj Punnen
