RAP: Prospective Pragmatic Multi-Site Trial Evaluating the Feasibility and Effect of Wrapping the Cavernous Nerves With a Novel Multi-Layer Perinatal Tissue Allograft During Prostatectomy
Summary
This clinical trial studies whether a new multi-layer perinatal tissue allograft, MLG-Complete (Trademark), can be used to improve complications after nerve-sparing robot-assisted radical prostatectomy (RARP) in patients with prostate cancer that has not spread to other parts of the body (localized). Two major complications that can happen after complete surgical removal of the prostate (radical prostatectomy) include erectile dysfunction and urinary incontinence, both of which greatly affect a patient's quality of life and social well-being. The goal of nerve-sparing radical prostatectomy is to preserve erectile and urinary function, but damage to the surrounding nerves and blood vessels can still occur causing the patient to experience the complications. An allograft is the transplant of an organ, tissue, or cells from one individual to another individual of the same species who is not an identical twin. The MLG-Complete allograft is made up of perinatal tissue and is placed on the nerve bundles during a nerve-sparing RARP. It is meant to serve as a barrier and provide coverage to the nerve bundles from the surrounding environment, which may improve post-nerve-sparing RARP complications.
Arms & interventions
- ProcedureAllografting
Undergo placement of MLG-Complete allograft
- OtherSurvey Administration
Ancillary studies
Outcome measures
Primary
Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
Feasibility is defined as the overall technical ability to place the MLG-Complete allograft in included patients without significantly lengthening operative time. This will be defined by a yes/no evaluation by the surgeon.
Time frame: Baseline [time of robot-assisted radical prostatectomy (RARP)]
Incidence of serious adverse events related to graft placement
Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: Up to 6 weeks post-RARP
Secondary
Average time for return of potency
Time frame: At 6-weeks and 3-, 6-, and 12-months post RARP
Average time for return to continence
Time frame: At 6-weeks and 3-, 6-, and 12-months post-RARP
Change in SHIM
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in AUASS
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in Quality of Life - AUASS survey
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in ICIQ-UI
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Change in QoL - EPIC-26
Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
Cost/value analysis
Time frame: Up to 12 months post-RARP
Unplanned interactions with the healthcare team
Time frame: Up to 12 weeks
Eligibility criteria
Study locations (1)
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980