Prostate Cancer Clinical Trial

Miami Membrane for Potency (MMEP) Trial

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.

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Full 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.

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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.

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT02710422

Recruitment Status:

Terminated

Sponsor:

University of Miami

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There is 1 Location for this study

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University of Miami
Miami Florida, 33136, United States

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Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

24

Study ID:

NCT02710422

Recruitment Status:

Terminated

Sponsor:


University of Miami

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