Clinical trial NCT06940271: Feasibility and Effect of Wrapping Nerves With a Multi-Layer Perinatal Tissue Allograft During Prostatectomy
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Localized Prostate Carcinoma
Stage I Prostate Cancer AJCC v8
Stage II Prostate Cancer AJCC v8
Stage III Prostate Cancer AJCC v8
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-04-23
Enrollment: 25
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ability to place MLG-Complete allograft without lengthening operative time (Feasibility)
timeFrame: Baseline [time of robot-assisted radical prostatectomy (RARP)]
measure: Incidence of serious adverse events related to graft placement
timeFrame: Up to 90 days post-RARP
Secondary outcomes:
measure: Average time for return of potency
timeFrame: At 6-weeks and 3-, 6-, and 12-months post RARP
measure: Average time for return to continence
timeFrame: At 6-weeks and 3-, 6-, and 12-months post-RARP
measure: Change in SHIM
timeFrame: At baseline (study enrollment), 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
measure: Change in AUASS
timeFrame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
measure: Change in Quality of Life - AUASS survey
timeFrame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
measure: Change in ICIQ-UI
timeFrame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
measure: Change in QoL - EPIC-26
timeFrame: At baseline, 6-weeks post-RARP, and 3-, 6-, and 12-months post-RARP
measure: Cost/value analysis
timeFrame: Up to 12 months post-RARP
measure: Unplanned interactions with the healthcare team
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Ram A. Pathak, MD
role: PRINCIPAL_INVESTIGATOR
References: