Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingInterventional

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

NCT ID: NCT06940271Sponsor: Mayo ClinicLast updated: 2025-11-10

Summary

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.

Arms & interventions

  • ProcedureAllografting

    Undergo placement of MLG-Complete allograft

  • OtherSurvey Administration

    Ancillary studies

Outcome measures

Primary

  • Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)

    Feasibility is defined as the overall technical ability to place the MLG-Complete allograft in included patients without significantly lengthening operative time. This will be defined by a yes/no evaluation by the surgeon.

    Time frame: Baseline [time of robot-assisted radical prostatectomy (RARP)]

  • Incidence of serious adverse events related to graft placement

    Will be assessed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Time frame: Up to 6 weeks post-RARP

Secondary

  • Average time for return of potency

    Time frame: At 6-weeks and 3-, 6-, and 12-months post RARP

  • Average time for return to continence

    Time frame: At 6-weeks and 3-, 6-, and 12-months post-RARP

  • Change in SHIM

    Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

  • Change in AUASS

    Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

  • Change in Quality of Life - AUASS survey

    Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

  • Change in ICIQ-UI

    Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

  • Change in QoL - EPIC-26

    Time frame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP

  • Cost/value analysis

    Time frame: Up to 12 months post-RARP

  • Unplanned interactions with the healthcare team

    Time frame: Up to 12 weeks

Eligibility criteria

Sex: MaleAge: 45 Years and olderHealthy volunteers: No
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

Study locations (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

Recruiting
Clinical Trials Referral Office · Contact
Ram Pathak, MD · Principal Investigator