Clinical trial NCT02710422: Miami Membrane for Potency (MMEP) Trial
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: Prostate Cancer
Amniotic Membrane Placement
Robotic Assisted Radical Prostatectomy
RARP
Human Amniotic Membrane Allograft
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Vivex Biomedical
First posted: 2016-03-16
Enrollment: 24
Sex: MALE
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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
* Men who are using non-oral erectile aids such as vacuum pump, intra-cavernous injections, MUSE, penile prosthesis.

Primary outcomes:
measure: The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group
timeFrame: Baseline, 12 Months Post-RARP
Secondary outcomes:
measure: Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
timeFrame: Baseline, 3, 6, 9 12 Months Post-RARP
measure: Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.
timeFrame: Baseline, 3, 6, 9 and 12 months Post-RARP
measure: Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP
timeFrame: 3, 6, 9 and 12 Months Post-RARP
measure: Rates of Urinary Control Experienced by Study Participants
timeFrame: Baseline, 3, 6, 9, and 12 months Post-RARP
measure: 5-year Rate of Prostate Cancer Recurrence Between Both Study Arms
timeFrame: 5 years post-RARP
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Sanoj Punnen, MD
role: PRINCIPAL_INVESTIGATOR
References: