Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 45 Years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests whether wrapping nerves with donated tissue called MLG-Complete during robot-assisted prostate removal is possible and may help reduce urine leaks and trouble getting erections. It is for men age 45 or older with untreated prostate cancer that has not spread outside the prostate, who plan to have surgery that saves nerves on both sides.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are male and age 45 or older.
- You have untreated prostate cancer that is only in the prostate.
- You plan to have your prostate removed with surgery that saves nerves on both sides.
- You have no erection problems at your visit, with a SHIM erection survey score of 19 or higher.
- You have no urinary tract infection at your visit.
- You are interested in sex that involves penetration.
- You are willing to follow the study doctor's directions and complete follow-up surveys.
- You can give written consent to join.
Who can't join
- You have high-risk cancer with plans for treatment before surgery or removal of all or part of the nerve and blood vessel bundles.
- You cannot learn and keep records of treatments to help erections, such as pills, a vacuum pump, or shots.
- You have had more than 14 days of treatment with drugs that weaken the immune system, including steroids; cancer-killing chemotherapy within one month before screening; or these drugs during screening.
- You have had hormone treatment, radiation to the pelvis, or certain prostate surgeries. Prior open surgery in the pelvis may also exclude you, except hernia repair; the listed time limit is unclear.
- You need pads for urine leaks, or your body mass index (BMI), a measure of weight compared with height, is over 40.
- You plan to have chemotherapy, radiation, hormone treatment, or open surgery during the study. You received an experimental drug within 30 days before signing up, or plan another experimental product or procedure during the study.
- You have a nerve or mental health disorder that could affect results, a condition that seriously limits participation or consent, or a history of not following medical treatment. Drug or alcohol abuse within the past 12 months, as judged by the lead doctor, also excludes you.
- You are allergic to aminoglycoside antibiotics, such as gentamicin or streptomycin.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Male subjects with age ≥ 45 * Primary diagnosis of prostate cancer selected for surgical intervention (radical prostatectomy) * Primary diagnosis of organ confined (i.e. localized) untreated prostate cancer * Planned elective radical prostatectomy with bilateral nerve sparing technique * Patient has no erectile dysfunction (SHIM score ≥ 19) at the time of consultation * Willing to comply with instruction of the investigator * Willing to comply with follow-up surveys * Ability to provide written consent * Negative urinary tract infection at the time of consultation * Interest in penetrative sexual intercourse Exclusion Criteria: * High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles * Unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications * History of \>14 days treatment with immunosuppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period * Prior hormonal therapy such as Lupron or oral anti-androgens * Poor urinary control at baseline requiring the use of pads for leakage * Previous history of pelvic radiation * Previous history of simple prostatectomy or transurethral prostate surgery * Patients with obesity defined as body mass index (BMI) \> 40 kg/m\^2 * History of open pelvic surgery ≤ 5 prior to registration (except for hernia repair) * Scheduled to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period * Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments * 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 * In the opinion of the principal investigator (PI), has a history of drug or alcohol abuse ≤ 12 months prior to registration * Allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin) * Received administration of an investigational drug within 30 days prior to registration, and/or has planned administration of another investigational product or procedure during participation in this study
Study sites (1)
FL
- Mayo Clinic in Florida · Jacksonville, FL 32224-9980Clinical Trials Referral Office · Study contact · 855-776-0015 · mayocliniccancerstudies@mayo.eduRam Pathak, MD · Principal investigatorMore trials in Jacksonville