Clinical trial NCT05081232: Continence and Potency Following Multi-Layer Perinatal Issue alloGraft
Official title: Radical Prostectomy (RAP): Prospective Trial Evaluating Return to Continence and Potency Following Radical Prostatectomy Using Novel Multi-Layer Perinatal Issue alloGraft
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post Operative Recovery
Keywords: Multi-Layered Perinatal Tissue Allograft
Robot-Assisted Radical Prostatectomy
Erectile Dysfunction
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2021-10-18
Enrollment: 0
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Male patients undergoing Robot-Assisted Radical Prostectomy and eligible will receive Human Umbilical Cord (UC) allograft. It is hypothesized that patients receiving UC allograft placed around the neurovascular bundle will facilitate earlier return to potency and continence compared to those that do not receive UC allografts.
Primary purpose: SUPPORTIVE_CARE

Brief 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).

Detailed description: Participation in this study will involve MLG (Multi-Layered Perinatal Tissue Allograft) allograft, which is implanted during the surgery. This allograft is currently FDA approved and used for several type of surgeries.

The Multi-Layered Perinatal Tissue Allograft- (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:

1. Male subjects with at least age of 30 to 65
2. Primary diagnosis of prostate cancer selected for surgical intervention (Radical Prostatectomy)
3. Primary diagnosis of organ confined untreated prostate cancer
4. Planned elective radical prostatectomy with bilateral nerve sparing technique
5. Negative urinalysis within 30 days prior to date of surgery
6. Patient has no erectile dysfunction (SHIM Score \< 14 ) prior to date of surgery
7. Patient has the willingness to comply with instruction of the investigator
8. Patient has the willingness to comply with follow-up surveys
9. Have ability to provide full written consent.

Exclusion Criteria:

1. High-risk cancer planned for neoadjuvant therapy, full or partial excision of neurovascular bundles
2. Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications
3. 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
4. Patients that have had prior hormonal therapy such as Lupron or oral anti-androgens
5. Patients with poor urinary control at baseline requiring the use of pads for leakage
6. Previous history of pelvic radiation
7. Previous history of simple prostatectomy or transurethral prostate surgery
8. Patients with obesity defined as BMI \> 40 kg/m2
9. History of open pelvic surgery within 5 years except for hernia repair
10. Poorly controlled diabetes (A1C \>8.5%)
11. Scheduled at the time of screening to undergo chemotherapy, radiation, hormone therapy, or open surgery during the study period
12. Any neurologic disorder or psychiatric disorder that might confound postsurgical assessments
13. 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
14. In the opinion of the PI, has a history of drug or alcohol abuse within last 12 months
15. Is allergic to Aminoglycoside antibiotics (such as Gentamicin and/or Streptomycin)
16. 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

Primary outcomes:
measure: Average time for return to potency
timeFrame: 1 month post-op
measure: Average time for return to potency
timeFrame: 3 month post-op
measure: Average time for return to potency
timeFrame: 6 month post-op
measure: Average time for return to potency
timeFrame: 12 month post-op
measure: Average time for return to continence
timeFrame: 1-2 days post-op
measure: Average time for return to continence
timeFrame: 1 month post-op
measure: Average time for return to continence
timeFrame: 3 month post-op
measure: Average time for return to continence
timeFrame: 6 month post-op
measure: Average time for return to continence
timeFrame: 12 month post-op
Secondary outcomes:
measure: Expanded prostate cancer index composite-26 (EPIC-26) Score
timeFrame: Months 1, 3, 6, and 12
measure: Abdominal VAS (Visual Analog Scale) Pain Score
timeFrame: Post-op Days 1 and 2
measure: Value analysis for a historical subset of patients who underwent same surgery as sexual health inventory for men (SHIM)-matched controls
timeFrame: Month 1 post-op
measure: Costs of prescription
timeFrame: Month 12 post-op
measure: Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) scores
timeFrame: Day 1 post-op
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor of Urology
name: Ram A Pathak, MD
role: PRINCIPAL_INVESTIGATOR
References:
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