Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy

Study Overview
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Brief Summary
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The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.

Official Title
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Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)

Conditions
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Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
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* Biological: BioDFence G3 Placental Tissue Membrane
* Procedure: Robot-Assisted Radical Prostatectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM). Exclusion Criteria: Men requiring any use of pads for urinary leakage. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED) Men with baseline EPIC26 scores < 60. Previous treatment for prostate cancer. Previous history of pelvic radiation. Patients with impaired decision-making capacity.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Membrane Arm: dHACM Group<br>Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months. | Biological: BioDFence G3 Placental Tissue Membrane<br>* The BioDFence G3 Placental Tissue Membrane is a three-layer tissue allograft consisting of amnion-chorion-amnion. Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP. The membrane will be cut into two longitudinal pieces and placed over each neurovascular bundle separately.<br>* Other names: Human Amnion Membrane Allograft;Procedure: Robot-Assisted Radical Prostatectomy<br>* Robot-assisted surgical removal of the prostate, administered standard of care.<br>* Other names: RARP;|
| Other: Control Arm: No dHACM Group<br>Participants will undergo standard of care RARP surgery but will have no dehydrated Human Amnion Chorion Membrane (dHACM) placed after removal of the prostate. Participants will be in the group for approximately 12 months. | Procedure: Robot-Assisted Radical Prostatectomy<br>* Robot-assisted surgical removal of the prostate, administered standard of care.<br>* Other names: RARP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score | Erectile function recovery among participants will be measured by the change in scores within the Sexual Domain of the Expanded Prostate Cancer Index Composite Short Form (EPIC26). The EPIC26 is a 26-item questionnaire used to measure health-related quality of life (HRQOL) among men with prostate cancer. The EPIC26 has five domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL. | Baseline, 12 Months Post-RARP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Erectile Function Recovery as Measured by SHIM Score | Erectile function recovery among participants will be measured as the change in Sexual History Inventory for Men (SHIM). The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED. | Baseline, 12 Months Post-RARP | 
| Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score | Proportion of men with mild ED or better as defined by an EPIC26 Sexual Domain score greater than or equal to 60. Response options for each EPIC item form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale with higher scores representing better sexual function. | Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP | 
| Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score | Proportion of participants with mild ED or better as defined by a SHIM score greater than or equal to 17. The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED. | Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP | 
| Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time | Proportion of participants with erections adequate for penetration greater than or equal to 50-percent of the time. | Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP | 
| Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids | Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis). | Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP | 
| Change in Rate of Urinary Control | Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day. | Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP | 
| Change in Biochemical Failure | Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level > 0.2 ng/ml on two consecutive samples. | Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP | 
| Number of Treatment-Related Adverse Events | The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale. | Up to 12 months post-RARP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostatectomy, Allograft Membrane