Prostate Cancer Clinical Trial
Continence and Potency Following Multi-Layer Perinatal Issue alloGraft
Summary
The purpose of this research is to determine the effectiveness of using human Umbilical Cord (UC) allograft to help improve return to erectile function and bladder control in patients following robot-assisted radical prostatectomy (RARP).
Full Description
Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allografdt, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries.
The MLG is processed from tissue according to the American Association of Tissue Banks (AATB) standards, and is regulated as a cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service Act. The grafts are distributed by Samaritan Biologics, LLC; an FDA-registered tissue bank.
The MLG allograft will be placed on each neurovascular bundle (NVB) bilaterally.
MLG is supplied as sterile sheets having dimensions of 2cm x 2cm and a thickness of approximately 0.8-1.0mm thick.
Participants receiving MLG will have it placed around the neurovascular bundle. Placement of the graft should not take over 5 minutes of time to impact overall surgical time length significantly.
Eligibility Criteria
Inclusion Criteria:
Male subjects with at least age of 30 to 65
Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
Primary diagnosis of organ confined 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 < 14 ) 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 immuno-suppressants (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 anti-androgens
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 BMI > 40 kg/m2
History of open pelvic surgery within 5 years except for hernia repair
Poorly controlled diabetes (A1C >8.5%)
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 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
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There is 1 Location for this study
Winston-Salem North Carolina, 27157, United States More Info
Principal Investigator
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