Randomized AmnioFix Study During Radical Prostatectomy (NCT02645591) | Clinical Trial Compass
WithdrawnPhase 2
Randomized AmnioFix Study During Radical Prostatectomy
0Started 2016-11
Plain-language summary
The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP).
dHACM is a section of tissue made from part of the placenta donated by a mother during a C-section. It looks like a small piece of tissue paper and is wrapped around the nerve bundles in the surgical area. The tissue may help the body's normal healing process.
Who can participate
Age range
35 Years – 75 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 35-75
. Primary diagnosis of prostate cancer selected for surgical intervention by one of the six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward).
. Have a willingness to comply with follow-up HRQOL (health related quality of life) surveys and PSA assessments.
. 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 nerve sparing technique that can include high or low fascia.
. Negative urinalysis within 30 days prior to date of surgery
Exclusion criteria
. High-risk cancer planned for neoadjuvant therapy, full or partial excision of one or both neurovascular bundles.
. Has any condition(s), which seriously compromises the subject's ability to participate in this study, sign consent, or has a known history of poor adherence with medical treatment.
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
Reducing Neurovascular Bundle Inflammation in Prostate Cancer Patients Undergoing Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)
. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications.
. In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months.
. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin).
. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.
. Patients currently enrolled in another study. Concurrent enrollment in another study is prohibited expect for the control arm which can be used for other protocols with HRQOL endpoints with similar instruments.
. Has had prior hormonal therapy such as Lupron or oral anti-androgens.