Miami Membrane for Potency (MMEP) Trial

Study Overview
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Brief Summary
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The use of dehydrated human amnionic membrane allograft improves erectile function recovery (as measured by (Sexual History Inventory for Men (SHIM) score) at 12 months after robotic assisted radical prostatectomy (RARP) compared to a control group with no allograft.

Detailed Description
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This is a phase 2 prospective randomized trial investigating the impact of amniotic membrane placement over the neurovascular bundles after bilateral nerve sparing robot assisted radical prostatectomy on potency. The study will have a control arm that will follow standard of care surgery, without placement of any membranes. 70 men will be allocated to each arm. The research study will involve follow up every 3 months for the first 12 months. After this the investigators will follow patients annually with prostate-specific antigen (PSA) measurements and an assessment of any secondary therapies for 5 years post-surgery. Randomization of study patients will be done in equal proportion to Arm I (membrane placement) and Arm II (no membrane placement, standard of care surgery) using a permuted block design stratified by baseline SHIM score (<17 vs. >=17), and use of ANY erectile aids (Yes vs. No) in the last 3 months.

Official Title
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Miami Membrane for Potency (MMeP) Trial to Assess the Impact of Dehydrated Human Amnion Membrane Allograft Placement During Robotic Radical Prostatectomy on Early Return of Erectile Function

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: Amniotic Membrane Placement
* Behavioral: EPIC 26
* Other: PSA Measurement
* Behavioral: Sexual History Inventory for Men


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami Exclusion Criteria: Men with poor urinary control at baseline requiring the use of pads for leakage Previous treatment for prostate cancer Previous history of pelvic radiation Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous injections, MUSE, penile prosthesis.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1 - Amniotic Membrane Placement<br>Participants who receive the human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. | Biological: Amniotic Membrane Placement<br>* Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.<br>* Other names: Human Amniotic Membrane Allograft;Behavioral: EPIC 26<br>* Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.<br>* Other names: Expanded Prostate Cancer Index Composite Short Form;Other: PSA Measurement<br>* Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.<br>* Other names: Prostate Specific Antigen Measurement;Behavioral: Sexual History Inventory for Men<br>* SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.<br>* Other names: SHIM;|
| Other: Arm 2 - No Amniotic Membrane Placement<br>Participants who do not receive human amniotic membrane placement after robotic assisted radical prostatectomy (RARP). Participants will also undergo PSA measurement and complete the EPIC 26 and Sexual History Inventory for Men (SHIM) psychosocial questionnaires at protocol-defined intervals. | Behavioral: EPIC 26<br>* Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.<br>* Other names: Expanded Prostate Cancer Index Composite Short Form;Other: PSA Measurement<br>* Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.<br>* Other names: Prostate Specific Antigen Measurement;Behavioral: Sexual History Inventory for Men<br>* SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.<br>* Other names: SHIM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group | The difference in average change in Sexual History Inventory for Men (SHIM) score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint. The SHIM score is measured in points on a scale: The minimum score is 5 to 7 indicating severe erectile dysfunction (ED), the maximum score is 22 to 25, indicating no ED. | Baseline, 12 Months Post-RARP | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group with mild ED or better, defined by a SHIM greater than or equal to 17, at 3, 6, 9 and 12 months post RARP. | Baseline, 3, 6, 9 12 Months Post-RARP | 
| Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will compare the proportion of men in each group who are able to achieve an erection sufficient for intercourse more than 50% of the time at 3, 6, 9 and 12 months post RARP. | Baseline, 3, 6, 9 and 12 months Post-RARP | 
| Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP | Among men with a SHIM greater than or equal to 17 at baseline, the investigators will evaluate the proportion of men who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis) at 3, 6, 9, and 12 months post RARP. | 3, 6, 9 and 12 Months Post-RARP | 
| Rates of Urinary Control Experienced by Study Participants | Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months, | Baseline, 3, 6, 9, and 12 months Post-RARP | 
| 5-year Rate of Prostate Cancer Recurrence Between Both Study Arms | Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy. | 5 years post-RARP | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer, Amniotic Membrane Placement, Robotic Assisted Radical Prostatectomy, RARP, Human Amniotic Membrane Allograft