Randomized AmnioFix Study During Radical Prostatectomy
Neurovascular Bundle Protection With an Amnion/Chorion Membrane Allograft to Improve Postoperative Functional Recovery: A Randomized Comparison to Standard Techniques
2 other identifiers
interventional
N/A
0 countries
N/A
Brief Summary
The goal of this clinical research study is to learn about the safety and the effectiveness of using AmnioFix® (dehydrated human amnion/chorion membrane, also called dHACM) to help improve the return of erectile function and bladder control in patients after robotic assisted laparoscopic radical prostatectomy (RARP). dHACM is a section of tissue made from part of the placenta donated by a mother during a C-section. It looks like a small piece of tissue paper and is wrapped around the nerve bundles in the surgical area. The tissue may help the body's normal healing process.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 31, 2015
CompletedFirst Posted
Study publicly available on registry
January 1, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2019
CompletedNovember 22, 2016
November 1, 2016
3 years
December 31, 2015
November 21, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reducing Neurovascular Bundle Inflammation in Prostate Cancer Patients Undergoing Nerve Sparing Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)
Outcome determined by a 10-point improvement in 3-month post-prostatectomy sexual function score using the Expanded Prostate Cancer Index Composite (EPIC) 26 in patients treated with the AmnioFix® graft compared to standard treatment.
3 months
Study Arms (2)
Nerve Sparing RARP + AmnioFix®
EXPERIMENTALParticipants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP) plus placement of a 2x12 sheet of AmnioFix® to the neurovascular bundle.
Nerve Sparing RARP
ACTIVE COMPARATORParticipants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP)
Interventions
Participants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP).
Dehydrated human amnion/chorion membrane (dHACM) wrapped around the nerve bundles at the end of Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP) surgery.
Questionnaire completed about erectile function before surgery, and at 6 weeks, 3 months, 6 months, and 12 months after surgery.
Eligibility Criteria
You may qualify if:
- Male subjects between the ages 35-75
- Primary diagnosis of prostate cancer selected for surgical intervention by one of the six protocol surgeons (Chapin, Davis, Matin, Pettaway, Pisters, Ward).
- Have a willingness to comply with follow-up HRQOL (health related quality of life) surveys and PSA assessments.
- Have ability to provide full written consent.
- Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, 7,8 or 9.
- Planned elective radical prostatectomy with bilateral nerve sparing technique that can include high or low fascia.
- Negative urinalysis within 30 days prior to date of surgery
You may not qualify if:
- High-risk cancer planned for neoadjuvant therapy, full or partial excision of one or both neurovascular bundles.
- 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.
- Is unable to comply with learning and documenting penile rehabilitation, including oral 5-phosphodiesterase inhibitor use, vacuum pump therapy use, and/or injectable medications.
- 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).
- 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 currently enrolled in another study. Concurrent enrollment in another study is prohibited expect for the control arm which can be used for other protocols with HRQOL endpoints with similar instruments.
- Has had prior hormonal therapy such as Lupron or oral anti-androgens.
- Unwilling to participate in follow-up clinical appointments at MDACC.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- MiMedx Group, Inc.collaborator
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John W. Davis, MD
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 31, 2015
First Posted
January 1, 2016
Study Start
November 1, 2016
Primary Completion
November 1, 2019
Last Updated
November 22, 2016
Record last verified: 2016-11