Actively Recruiting
Prospective Trial Evaluating MLG-Complete Multi-Layer Perinatal Tissue Allograft During Nerve-Sparing Robot-Assisted Radical Prostatectomy in Localized Prostate Cancer
Led by Mayo Clinic · Updated on 2025-11-10
25
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a new multi-layer perinatal tissue allograft called MLG-Complete can help reduce complications following nerve-sparing robot-assisted radical prostatectomy (RARP) in men with localized prostate cancer. This study focuses on two common issues after prostate removal surgery: erectile dysfunction and urinary incontinence, which significantly impact quality of life. The allograft is designed to protect nerve bundles during surgery to potentially improve these outcomes. During the surgery, the MLG-Complete allograft is placed over the nerve bundles within about five minutes as part of the standard nerve-sparing RARP procedure. This placement aims to act as a barrier to shield nerves from damage. The study involves only one treatment group receiving the allograft during their prostatectomy. Participants will be monitored for their ability to have the allograft placed without increasing surgery time and for any serious side effects within six weeks after surgery. Researchers will assess recovery of erectile function and urinary control at multiple points up to 12 months post-surgery using various surveys and questionnaires. Other evaluations include quality of life, healthcare use, and cost analysis related to the treatment. Follow-up includes surveys and clinical assessments throughout the year after surgery.
CONDITIONS
Brief Title
Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged 45 years or older
- Diagnosis of localized prostate cancer planned for radical prostatectomy
- Planned elective radical prostatectomy with bilateral nerve-sparing technique
- Negative urinalysis within 30 days before surgery
- No erectile dysfunction with SHIM score 19 or higher at consultation
- Willingness to comply with study instructions and follow-up surveys
- Ability to provide written consent
- Negative urinary tract infection at consultation
- Interest in penetrative sexual intercourse
You will not qualify if you...
- High-risk cancer planned for neoadjuvant therapy or neurovascular bundle excision
- Unable to comply with penile rehabilitation methods
- Recent immunosuppressant or chemotherapy treatment within specified timeframes
- Prior hormonal therapy such as Lupron or oral anti-androgens
- Poor urinary control requiring pads at baseline
- History of pelvic radiation or prostate surgery
- Obesity with BMI over 40 kg/m²
- History of open pelvic surgery within 5 years except hernia repair
- Scheduled chemotherapy, radiation, hormone therapy, or open surgery during study
- Neurologic or psychiatric disorders affecting assessments
- Conditions compromising study participation or consent ability
- Recent drug or alcohol abuse within 12 months
- Allergy to aminoglycoside antibiotics
- Recent or planned investigational drug use within 30 days of registration
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants undergo placement of the MLG-Complete allograft to nerve bundles during standard nerve-sparing robot-assisted radical prostatectomy (RARP).
1 visit (in-person)
Duration - Up to 12 months post-surgery
Participants are monitored for safety and recovery, including assessment of potency, continence, and quality of life through surveys.
Visits at 6 weeks, and 3, 6, and 12 months post-surgery
Trial Site Locations
Total: 1 location
1
Mayo Clinic in Florida
Jacksonville, Florida, United States, 32224-9980
Actively Recruiting
Research Team
C
Clinical Trials Referral Office
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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