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Miami Membrane for Potency (MMEP) Trial (MMEP)

This study is currently recruiting participants.
See Contacts and Locations
Verified March 2017 by Sanoj Punnen, University of Miami
Sponsor:
Collaborator:
Vivex Biomedical
Information provided by (Responsible Party):
Sanoj Punnen, University of Miami
ClinicalTrials.gov Identifier:
NCT02710422
First received: March 11, 2016
Last updated: March 30, 2017
Last verified: March 2017
  Purpose
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.

Condition Intervention Phase
Prostate Cancer Biological: Amniotic Membrane Placement Behavioral: EPIC 26 Other: PSA Measurement Behavioral: Sexual History Inventory for Men Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant
Masking Description:
Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sanoj Punnen, University of Miami:

Primary Outcome Measures:
  • 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 SHIM score, between baseline and 12 months post RARP between the membrane and control arms will be assessed as the primary endpoint.


Secondary Outcome Measures:
  • Proportion of Men in Each Group with Mild Erectile Dysfunction (ED) or Better 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 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.

  • 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: 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.

  • Proportion of Men in Each Group Who Require the Use 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 in each group 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.

  • Rates of Urinary Control Experienced by Study Participants [ Time Frame: 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,


Other Outcome Measures:
  • Rate of Adverse Events in Study Participants [ Time Frame: Up to 12 Months post-RARP ]
    Rates of Adverse Events in Study Participants categorized by type and severity using NIH CTCAE version 4 criteria.

  • Rates of Biochemical Failure in Study Participants [ Time Frame: 3, 6, 9, and 12 months Post-RARP ]
    Rate of biochemical failure will be assessed and reported at 3, 6, 9, and 12 months. Biochemical failure post-radical prostatectomy is defined as a Prostate Specific Antigen (PSA) level of > 0.2 ng/ml on 2 or more consecutive reads.


Estimated Enrollment: 280
Actual Study Start Date: May 17, 2016
Estimated Study Completion Date: April 2021
Estimated Primary Completion Date: April 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Human Amniotic Membrane Allograft
Behavioral: EPIC 26
Participants will receive EPIC 26 psychosocial questionnaire at baseline, and at 3, 6, 9 and 12 months post-RARP.
Other Name: Expanded Prostate Cancer Index Composite Short Form
Other: PSA Measurement
Measurement of serum PSA levels at baseline, and at 3, 6, 9 and 12 months post-RARP.
Other Names:
  • PSA Test
  • Prostate Specific Antigen Measurement
Behavioral: Sexual History Inventory for Men
Sexual History Inventory for Men (SHIM) psychosocial questionnaire administered 3,6, 9 and 12 months post-RARP.
Other Name: SHIM
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 at 3, 6, 9 and 12 months post-RARP.
Other Name: Expanded Prostate Cancer Index Composite Short Form
Other: PSA Measurement
Measurement of serum PSA levels at baseline, and at 3, 6, 9 and 12 months post-RARP.
Other Names:
  • PSA Test
  • Prostate Specific Antigen Measurement
Behavioral: Sexual History Inventory for Men
Sexual History Inventory for Men (SHIM) psychosocial questionnaire administered 3,6, 9 and 12 months post-RARP.
Other Name: SHIM

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. 140 men will be allocated to each arm.

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.

Patients will be followed up every three months for a total of one year. This follow up schedule meets the current standard of care after radical prostatectomy. At each follow up a serum PSA will be assessed for recurrence on prostate cancer. To investigate primary and secondary endpoints a self-reported validated questionnaire will be provided assessing measures of potency. Finally, the use of pads for urinary leakage will be assessed at each time point.

The research study will end at 12 months from radical prostatectomy of the last enrolled patient

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02710422

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Sanoj Punnen, MD    305-243-3246    s.punnen@med.miami.edu   
Contact: Dipen Parekh, MD    305-243-6591    DParekh@med.miami.edu   
Principal Investigator: Sanoj Punnen, MD         
Principal Investigator: Dipen Parekh, MD         
Sponsors and Collaborators
University of Miami
Vivex Biomedical
Investigators
Principal Investigator: Sanoj Punnen, MD University of Miami
  More Information

Responsible Party: Sanoj Punnen, Associate Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT02710422     History of Changes
Other Study ID Numbers: 20150952
Study First Received: March 11, 2016
Last Updated: March 30, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Keywords provided by Sanoj Punnen, University of Miami:
Prostate Cancer
Amniotic Membrane Placement
Robotic Assisted Radical Prostatectomy
RARP
Human Amniotic Membrane Allograft

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases

ClinicalTrials.gov processed this record on June 22, 2017