Prostate CancerPhase 2MMEPNCT02710422
Miami Membrane for Potency (MMEP) Trial
A Phase 2 study testing Amniotic Membrane Placement, EPIC 26 and PSA Measurement in people with Prostate Cancer, run by University of Miami at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Amniotic Membrane Placement, EPIC 26 and PSA Measurement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2016to 22 Jan 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Amniotic Membrane Placement, EPIC 26, PSA Measurement, Sexual History Inventory for Men
- Keywords
- Prostate Cancer, Amniotic Membrane Placement, Robotic Assisted Radical Prostatectomy, RARP, Human Amniotic Membrane Allograft
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic Membrane PlacementBiological
Also called Human Amniotic Membrane Allograft
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 26Behavioural
Also called Expanded Prostate Cancer Index Composite Short Form
Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
PSA MeasurementOther
Also called PSA Test, Prostate Specific Antigen Measurement
Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.
Sexual History Inventory for MenBehavioural
Also called SHIM
SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Amniotic Membrane Placement | Experimental | 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. Receives: Biological: Amniotic Membrane Placement; Behavioral: EPIC 26; Other: PSA Measurement; Behavioral: Sexual History Inventory for Men |
| Arm 2 - No Amniotic Membrane Placement | Other | 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. Receives: Behavioral: EPIC 26; Other: PSA Measurement; Behavioral: Sexual History Inventory for Men |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 Months Post-RARP
Secondary outcomes (5)
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.
Measured: Baseline, 3, 6, 9 12 Months Post-RARP
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.
Measured: Baseline, 3, 6, 9 and 12 months Post-RARP
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.
Measured: 3, 6, 9 and 12 Months Post-RARP
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,
Measured: Baseline, 3, 6, 9, and 12 months Post-RARP
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.
Measured: 5 years post-RARP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2016 (estimated)
- Study start17 May 2016
- Primary completion22 Jan 2019
- Study completion22 Jan 2019
Why it stopped: Lack of Accrual and Inadequate Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Vivex Biomedical
- Responsible party
- Principal investigator, Sanoj Punnen, University of Miami
- Investigators
- Sanoj Punnen, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710422
- Sponsor's protocol ID
- 20150952
- Acronym
- MMEP
- Status last verified
- Aug 2019
- First submitted
- 11 Mar 2016
- Last updated
- 11 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02710422
- Acronym / sponsor ID
- MMEP / 20150952
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Amniotic Membrane Placement, Robotic Assisted Radical Prostatectomy, RARP, Human Amniotic Membrane Allograft
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of Accrual and Inadequate Funding
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Vivex Biomedical
- Study start
- 17 May 2016 (actual)
- Primary completion
- 22 Jan 2019 (actual)
- Study completion
- 22 Jan 2019 (actual)
- First posted
- 16 Mar 2016 (estimated)
- Results
- Posted 11 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Amniotic Membrane Placement | Experimental | Biological: Amniotic Membrane Placement, Behavioral: EPIC 26, Other: PSA Measurement, Behavioral: Sexual History Inventory for MenParticipants 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. |
| Arm 2 - No Amniotic Membrane Placement | Other | Behavioral: EPIC 26, Other: PSA Measurement, Behavioral: Sexual History Inventory for MenParticipants 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Men age 40-80 with localized prostate cancer who are undergoing bilateral nerve sparing RARP at the University of Miami
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Amniotic Membrane PlacementAlso: Human Amniotic Membrane AllograftAmniotic 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. | Biological | Arm 1 - Amniotic Membrane Placement |
| EPIC 26Also: Expanded Prostate Cancer Index Composite Short FormParticipants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals. | Behavioural | Arm 1 - Amniotic Membrane Placement, Arm 2 - No Amniotic Membrane Placement |
| PSA MeasurementAlso: PSA Test, Prostate Specific Antigen MeasurementMeasurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years. | Other | Arm 1 - Amniotic Membrane Placement, Arm 2 - No Amniotic Membrane Placement |
| Sexual History Inventory for MenAlso: SHIMSHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals. | Behavioural | Arm 1 - Amniotic Membrane Placement, Arm 2 - No Amniotic Membrane Placement |
Primary outcome
The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group
Time frame: 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.
5 secondary outcomes
Proportion of Men in Each Group With Mild Erectile Dysfunction (ED) or Better Post-RARP
Time frame: Baseline, 3, 6, 9 12 Months Post-RARP
Proportion of Men in Each Group Who Are Able to Achieve An Erection Sufficient for Intercourse More the 50% of the Time Post-RARP.
Time frame: Baseline, 3, 6, 9 and 12 months Post-RARP
Proportion of Men Who Require the Use of More Invasive Erectile Aids Post-RARP
Time frame: 3, 6, 9 and 12 Months Post-RARP
Rates of Urinary Control Experienced by Study Participants
Time frame: Baseline, 3, 6, 9, and 12 months Post-RARP
5-year Rate of Prostate Cancer Recurrence Between Both Study Arms
Time frame: 5 years post-RARP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanoj Punnen, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Amniotic Membrane Placement, EPIC 26 and PSA Measurement in people with Prostate Cancer, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Difference in Average Change in SHIM Score, Between Baseline and 12-Months Post-RARP, of Study Participants in Each Group (time frame: Baseline, 12 Months Post-RARP). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019; AzTrials last refreshed its copy on 28 Oct 2026.