Wrapping nerves with a multi-layer perinatal tissue graft during prostate removal
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
NA · Mayo Clinic · NCT06940271
This trial will test whether wrapping the nerves with a multi-layer perinatal tissue allograft during nerve-sparing robotic prostate removal helps men with localized prostate cancer keep erectile and urinary function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 45 Years and up |
| Sex | Male |
| Sponsor | Mayo Clinic (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Jacksonville, Florida) |
| Trial ID | NCT06940271 on ClinicalTrials.gov |
What this trial studies
This interventional study places a multi-layer perinatal tissue allograft (MLG-Complete) around the neurovascular bundles during planned bilateral nerve-sparing robot-assisted radical prostatectomy. Eligible men are adults with localized prostate cancer, baseline normal erectile function (SHIM ≥ 19), negative urine testing, and interest in penetrative intercourse. Patients will follow standard penile rehabilitation protocols and complete postoperative surveys to track erectile function and urinary continence over follow-up. The procedure and outcomes are being tested at a single site (Mayo Clinic in Florida).
Who should consider this trial
Good fit: Men aged 45 or older with localized, untreated prostate cancer scheduled for elective bilateral nerve-sparing robotic radical prostatectomy who have no baseline erectile dysfunction (SHIM ≥ 19) and no current urinary infection.
Not a fit: Patients with high-risk disease requiring neoadjuvant therapy or planned partial/full excision of neurovascular bundles, those with pre-existing erectile dysfunction, or those unable to comply with penile rehabilitation are unlikely to benefit.
Why it matters
Potential benefit: If successful, the graft could reduce the severity or duration of erectile dysfunction and urinary incontinence after prostate removal, improving quality of life.
How similar studies have performed: Related uses of perinatal or amniotic-derived grafts for nerve protection have shown promising but limited results in small studies, so this approach is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion 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 * Negative urinalysis within 30 days prior to date of surgery * 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
Where this trial is running
Jacksonville, Florida
- Mayo Clinic in Florida — Jacksonville, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Ram A. Pathak, MD — Mayo Clinic
- Study coordinator: Clinical Trials Referral Office
- Email: mayocliniccancerstudies@mayo.edu
- Phone: 855-776-0015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Prostate Cancer AJCC v8