DHACM in Robotic Assisted Laparoscopic Prostatectomy (RALP)
United States230 participantsStarted 2015-10-01
Plain-language summary
The investigators will examine the beneficial impacts of applying of dHACM on the preserved neurovascular bundles (cavernosal nerves) and the prostate bed during robotic assisted laparoscopic prostatectomy. Such application can result in promotion of soft tissue healing and reduction of inflammation at the operative site and thus an acceleration of return of potency regulating cavernosal nerves.
Who can participate
Age range
40 Years – 70 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male subjects between the ages 40-70.
. Primary diagnosis of prostate cancer requiring surgical intervention
. Have a willingness to comply with follow-up examination
. Have ability to provide full written consent
. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9
. Planned elective radical prostatectomy with bilateral full nerve sparing technique
. Patients who currently have a pre-operative SHIM \> 19
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Potency as assessed by Sexual Health Inventory for Men (SHIM) Score
. Negative urinalysis within 7 days prior to date of surgery
Exclusion criteria
. Has signs or symptoms of any other disease which could result in allograft failure, or has experienced graft failure in the past
. Has any condition(s), which seriously compromises the subject's ability to participate in this study, or has a known history of poor adherence with medical treatment
. Has comorbid conditions that can be confused with or can exacerbate the condition, including diabetes or Advanced atherosclerotic vascular disease
. Is unable to sign or understand informed consent
. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor
. Has a history of drug or alcohol abuse within last 12 months
. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)