Miami Membrane for Potency (MMEP) Trial

Prostate Cancer Clinical Trial

— MMEP  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02710422
• Other study ID #: 20150952
• Status: Terminated
• Phase: Phase 2
• Start date: May 17, 2016
• Est. completion date: January 22, 2019

Study information

• Verified date: August 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: January 22, 2019
• Est. primary completion date: January 22, 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.

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

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

Behavioral:
• Sexual History Inventory for Men
SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Vivex Biomedical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group	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.	Baseline, 12 Months Post-RARP
Secondary	Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better 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.	Baseline, 3, 6, 9 12 Months Post-RARP
Secondary	Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time 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.	Baseline, 3, 6, 9 and 12 months Post-RARP
Secondary	Proportion of Men Who Require the Use of More Invasive Erectile Aids 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.	3, 6, 9 and 12 Months Post-RARP
Secondary	Rates of Urinary Control Experienced by Study Participants	Rates of urinary control as measured by no pads per day at 3, 6, 9, and 12 months,	Baseline, 3, 6, 9, and 12 months Post-RARP
Secondary	5-year Rate of Prostate Cancer Recurrence Between Both Study Arms	Rate of prostate cancer recurrence in study participants in both study arms at 5 years post-radical prostatectomy.	5 years post-RARP