NCT02710422 (MMEP) is a Phase 2 clinical trial of Amniotic Membrane Placement in Prostate Cancer, sponsored by University of Miami.

Who is sponsoring NCT02710422?

NCT02710422 is sponsored by University of Miami.

What drugs are being tested in NCT02710422?

Interventions in NCT02710422: Amniotic Membrane Placement, EPIC 26, PSA Measurement, Sexual History Inventory for Men.

What condition does NCT02710422 study?

NCT02710422 studies Prostate Cancer.

Is NCT02710422 still recruiting?

NCT02710422 is currently terminated. Last updated 11 September 2019.

Are results published for NCT02710422?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-09-11 · How we verify

NCT02710422: MMEP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Miami Membrane for Potency (MMEP) Trial

Terminated Phase 2 Results posted Last updated 11 September 2019

What this trial tests

Phase 2 trial testing Amniotic Membrane Placement in Prostate Cancer in 24 participants. Terminated before completion.

Timeline

17 May 2016

Primary endpoint
22 January 2019

22 January 2019

Quick facts

Lead sponsor	University of Miami
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	24
Start date	17 May 2016
Primary completion	22 January 2019
Estimated completion	22 January 2019
Sites	1 location across United States

Drugs / interventions tested

Amniotic Membrane Placement — full drug profile →
EPIC 26
PSA Measurement
Sexual History Inventory for Men

Conditions studied

Prostate Cancer — all drugs for Prostate Cancer →

Sponsor

University of Miami

Who can join

Adults 40 to 80, male only, with Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	10	± 12.288
Arm 2 - No Amniotic Membrane Placement	13.33	± 6.429

Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP Secondary · 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.

Mild or Better ED, Baseline

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	100
Arm 2 - No Amniotic Membrane Placement	100

Mild or Better ED, 3 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	0
Arm 2 - No Amniotic Membrane Placement	0

Mild or Better ED, 6 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	0
Arm 2 - No Amniotic Membrane Placement	0

Mild or Better ED, 9 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	0
Arm 2 - No Amniotic Membrane Placement	0

Mild or Better ED, 12 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	66.67
Arm 2 - No Amniotic Membrane Placement	0

Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP. Secondary · 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.

3 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	0
Arm 2 - No Amniotic Membrane Placement	0

6 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	0
Arm 2 - No Amniotic Membrane Placement	0

9 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	0
Arm 2 - No Amniotic Membrane Placement	0

12 months

Group	Value	95% CI
Arm 1 - Amniotic Membrane Placement	66.67
Arm 2 - No Amniotic Membrane Placement	0

Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP Secondary · 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.

3 months Post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	0
Arm 2: No Amniotic Membrane Placement	0

6 months Post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	0
Arm 2: No Amniotic Membrane Placement	0

9 months Post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	0
Arm 2: No Amniotic Membrane Placement	33.33

12 months Post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	66.67
Arm 2: No Amniotic Membrane Placement	100

Rates of Urinary Control Experienced by Study Participants Secondary · 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,

No Pad Usage: Baseline

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	100
Arm 2 - No Amniotic Membrane Placement	100

No Pad Usage: 3 months post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	22.22
Arm 2 - No Amniotic Membrane Placement	27.27

No Pad Usage: 6 months Post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	42.86
Arm 2 - No Amniotic Membrane Placement	50

No Pad Usage: 9 months Post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	60
Arm 2 - No Amniotic Membrane Placement	60

No Pad Usage: 12 months Post-RARP

Group	Value	95% CI
Arm 1: Amniotic Membrane Placement	100
Arm 2 - No Amniotic Membrane Placement	33.33

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

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Currently open trials in the same condition.

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Other University of Miami trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02710422 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 11 September 2019

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02710422.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing