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NCT05842057 · ClinicalTrials.gov registry record · Phase 2
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
A Phase 2 study of Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, sponsored by University of Miami.
- Active
- Registry status
- Phase 2
- Development phase
- 118
- Enrollment target
- 1
- Study location
NCT05842057: Active Phase 2 study of Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, sponsored by University of Miami.
NCT05842057 is a Phase 2 study of Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy that is active but no longer recruiting, run by University of Miami. The registered enrollment target is 118 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05842057, a Phase 2 study of Prostate Cancer and Erectile Dysfunction Following Radical Prostatectomy, is active but no longer recruiting, sponsored by University of Miami.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 118 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.
Primary Outcome
Erectile function recovery among participants will be measured by the change in scores within the Sexual Domain of the Expanded Prostate Cancer Index Composite Short Form (EPIC26). The EPIC26 is a 26-item questionnaire used to measure health-related quality of life (HRQOL) among men with prostate cancer. The EPIC26 has five domains: Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal. Response options for each EPIC item form a Likert scale, and multi-item scale scor
Conditions Studied
Interventions
- PROCEDURE Robot-Assisted Radical Prostatectomy
- BIOLOGICAL BioDFence G3 Placental Tissue Membrane
Study Locations (1)
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 118 participants |
| Start Date | 2023-08-24 |
| Est. Completion | 2028-08-31 |
| Phase | Phase 2 |
What the registry record for NCT05842057 still lists
NCT05842057 is an interventional study that assigns participants to a tested intervention. The registered 118 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Robot-Assisted Radical Prostatectomy is the first listed.
NCT05842057 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT05842057 about?
NCT05842057 is a clinical study titled "Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy". The purpose of this research study is to evaluate if placing a dehydrated human amnion chorion membrane (dHACM) over the nerves after removal of the prostate during surgery (radical prostatectomy) will allow an earlier recovery of erectile function and urinary control after surgery.
What is the current status of trial NCT05842057?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 118 participants. The study started on 2023-08-24. Estimated completion is 2028-08-31.
What conditions does trial NCT05842057 study?
This clinical trial studies the following conditions: Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy.
What interventions are being tested in trial NCT05842057?
The interventions under investigation include: Robot-Assisted Radical Prostatectomy (PROCEDURE), BioDFence G3 Placental Tissue Membrane (BIOLOGICAL).
Who is sponsoring clinical trial NCT05842057?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05842057 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05842057's enrollment target sits among peer trials
118 311th of 735 higher than 423 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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