Miami Membrane for Potency (MMEP) Trial

Phase 2

Terminated

• Conditions: Prostate Cancer
• Interventions: Behavioral: EPIC 26; Biological: Amniotic Membrane Placement; Other: PSA Measurement; Behavioral: Sexual History Inventory for Men

• Registration Number: NCT02710422
• Lead Sponsor: University of Miami

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-03-11
• Study First Submitted QC: 2016-03-11
• Study First Posted: 2016-03-16
• Study Start: 2016-05-17
• Primary Completion: 2019-01-22
• Study Completion: 2019-01-22
• Results First Submitted: 2019-07-27
• Status Verified: 2019-08
• Results First Submitted QC: 2019-08-16
• Last Update Submitted: 2019-08-16
• Results First Posted: 2019-09-11
• Last Update Posted: 2019-09-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

• Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 - Amniotic Membrane Placement	PSA Measurement	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.
Arm 2 - No Amniotic Membrane Placement	EPIC 26	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.
Arm 1 - Amniotic Membrane Placement	EPIC 26	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.
Arm 1 - Amniotic Membrane Placement	Sexual History Inventory for Men	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.
Arm 1 - Amniotic Membrane Placement	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.
Arm 2 - No Amniotic Membrane Placement	PSA Measurement	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.
Arm 2 - No Amniotic Membrane Placement	Sexual History Inventory for Men	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.

Primary Outcome Measures

Name	Time	Method
The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group	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.

Secondary Outcome Measures

Name	Time	Method
5-year Rate of Prostate Cancer Recurrence Between Both Study Arms	5 years post-RARP	Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP	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.
Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.	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.
Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP	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.
Rates of Urinary Control Experienced by Study Participants	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,

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States