RECRUITING

Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy

Conditions

Localized Prostate Carcinoma Stage I Prostate Cancer AJCC v8 Stage II Prostate Cancer AJCC v8 Stage III Prostate Cancer AJCC v8

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-08-14

Study Completion:2030-07-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06940271

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years

Sexes Eligible for Study:MALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male subjects with age of at least 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) prior to date of surgery * Patient has the willingness to comply with instruction of the investigator * Patient has the willingness to comply with follow-up surveys * Have ability to provide full written consent	* High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles * Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications * Patients with a history of more than two weeks treatment with immunosuppressants (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 that have had prior hormonal therapy such as Lupron or oral antiandrogens * Patients with 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 within 5 years except for hernia repair * Scheduled at the time of screening 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 within last 12 months * Is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin) * Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study * Patients not interested in penetrative sexual intercourse

Inclusion Criteria

Exclusion Criteria

* Male subjects with age of at least 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) prior to date of surgery
* Patient has the willingness to comply with instruction of the investigator
* Patient has the willingness to comply with follow-up surveys
* Have ability to provide full written consent

* High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
* Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
* Patients with a history of more than two weeks treatment with immunosuppressants (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 that have had prior hormonal therapy such as Lupron or oral antiandrogens
* Patients with 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 within 5 years except for hernia repair
* Scheduled at the time of screening 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 within last 12 months
* Is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
* Received administration of an investigational drug within 30 days prior to study, and/or has planned administration of another investigational product or procedure during participation in this study
* Patients not interested in penetrative sexual intercourse

Contacts and Locations

Study Contact

Clinical Trials Referral Office

CONTACT

855-776-0015

mayocliniccancerstudies@mayo.edu

Principal Investigator

Ram A. Pathak, MD

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic Hospital in Arizona

Phoenix, Arizona, 85054

United States

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980

United States

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Ram A. Pathak, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-14

Study Completion Date2030-07-30

Study Record Updates

Study Start Date2025-08-14

Study Completion Date2030-07-30

Terms related to this study

Additional Relevant MeSH Terms

Localized Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8