Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Prostatic Neoplasms

Dehydration

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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.

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.

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.

Amniotic Membrane Placement

Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

EPIC 26

Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

PSA Measurement

SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Sexual History Inventory for Men

Sanoj Punnen, MD

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.

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.

Participants will not know their treatment arm assignment until after robotic assisted radical prostatectomy (RARP) surgery.

Miami Membrane for Potency (MMEP) Trial

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 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.

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.

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.

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 as measured by no pads per day at 3, 6, 9, and 12 months,

Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.

Vivex Biomedical

University of Miami

Associate Professor of Clinical

Per protocol, non-serious adverse events (AEs) were only monitored, assessed and recorded if they were attributed to the membrane placement during the RARP procedure.

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.

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.

EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Arm 1 - 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.

EPIC 26: Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.

PSA Measurement: Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.

SHIM: Psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Arm 2 - No Amniotic Membrane Placement

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Sexual History Inventory for Men (SHIM) psychosocial questionnaire. The SHIM score measures the severity of the participant's Erectile Dysfunction (ED) in points on a scale as follows:

* 22 - 25: No significant erectile dysfunction
* 17 - 21: Mild erectile dysfunction
* 12 - 16: Mild-to-moderate erectile dysfunction
* 8 - 11: Moderate erectile dysfunction
* 5 - 7: Severe erectile dysfunction

SHIM Score

A measure of the amount of prostate-specific antigen (PSA) in the blood.

PSA Level

Due to early study termination, not all study participants completed scheduled visits.

Sanoj Punnen MD, MAS

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

Mild or Better ED, Baseline

Mild or Better ED, 3 months

Mild or Better ED, 6 months

Mild or Better ED, 9 months

Mild or Better ED, 12 months

Participants with a SHIM score of greater than or equal to 17 at baseline. Due to early study termination, not all study participants completed scheduled visits.

Spots Global Cancer Trial Database for Miami Membrane for Potency (MMEP) Trial

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial