Miami Membrane for Potency (MMEP) Trial (MMEP)

August 16, 2019 updated by: Sanoj Punnen, University of Miami

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1 - Amniotic Membrane Placement
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
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.
Other Names:
  • Human Amniotic Membrane Allograft
Behavioral: EPIC 26
Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
Other Names:
  • Expanded Prostate Cancer Index Composite Short Form
Other: PSA Measurement
Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.
Other Names:
  • PSA Test
  • Prostate Specific Antigen Measurement
Behavioral: Sexual History Inventory for Men
SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
Other Names:
  • SHIM
Other: Arm 2 - No Amniotic Membrane Placement
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
Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
Other Names:
  • Expanded Prostate Cancer Index Composite Short Form
Other: PSA Measurement
Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.
Other Names:
  • PSA Test
  • Prostate Specific Antigen Measurement
Behavioral: Sexual History Inventory for Men
SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
Other Names:
  • SHIM

What is the study measuring?

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
Time Frame: Baseline, 12 Months Post-RARP
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
Time Frame: Baseline, 3, 6, 9 12 Months 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.
Time Frame: Baseline, 3, 6, 9 and 12 months 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
Time Frame: 3, 6, 9 and 12 Months 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
Time Frame: Baseline, 3, 6, 9, and 12 months Post-RARP
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
Time Frame: 5 years post-RARP
Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.
5 years post-RARP

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Vivex Biomedical

Investigators

  • Principal Investigator: Sanoj Punnen, MD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2016

Primary Completion (Actual)

January 22, 2019

Study Completion (Actual)

January 22, 2019

Study Registration Dates

First Submitted

March 11, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Actual)

September 11, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20150952

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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