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BioDFence G3 Placental Tissue Membrane · 1 trial · 2 indications
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 scores are transformed linearly to a 0-100 scale with higher scores representing better HRQOL.
| Arm | Type | Description |
|---|---|---|
| Membrane Arm: dHACM Group | EXPERIMENTAL | Participants will undergo standard of care robot-assisted radical prostatectomy (RARP) surgery and the dehydrated Human Amnion Chorion Membrane (dHACM) membrane placed after removal of the prostate. Participants will be in the group for approximately 12 months. |
| Control Arm: No dHACM Group | OTHER | Participants will undergo standard of care RARP surgery but will have no dehydrated Human Amnion Chorion Membrane (dHACM) placed after removal of the prostate. Participants will be in the group for approximately 12 months. |
| Name | Type | Description |
|---|---|---|
| BioDFence G3 Placental Tissue Membrane | BIOLOGICAL | The BioDFence G3 Placental Tissue Membrane is a three-layer tissue allograft consisting of amnion-chorion-amnion. Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP. The membrane will be cut into two longitudinal pieces and placed over each neurovascular bundle separately. |
| Robot-Assisted Radical Prostatectomy | PROCEDURE | Robot-assisted surgical removal of the prostate, administered standard of care. |
Inclusion Criteria: 1\. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM). Exclusion Criteria: 1. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED). 2. Men with baseline EPIC26 scores \< 50. 3. Patients w...
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BioDFence G3 Placental Tissue Membrane is an investigational human amnion membrane allograft being studied for use in prostate cancer, specifically to support early return of erectile function after radical prostatectomy. It is a placental tissue membrane product developed by Integra LifeSciences Holdings Corporation.
BioDFence G3 Placental Tissue Membrane is developed by Integra LifeSciences Holdings Corporation, a company traded on the NASDAQ under the ticker IART. The product is currently in clinical development for prostate cancer.
BioDFence G3 Placental Tissue Membrane is in Phase 2 clinical development. It is an investigational product and has not been approved by the FDA. The ongoing Phase 2 trial is active but not recruiting participants.
BioDFence G3 Placental Tissue Membrane is being evaluated in one Phase 2 clinical trial with the identifier NCT05842057. This randomized, double-blind, controlled trial is studying the human amnion membrane allograft for early return of erectile function after radical prostatectomy in men with prostate cancer.
BioDFence G3 Placental Tissue Membrane is a human amnion membrane allograft, a placental tissue membrane product. It is being studied to support early return of erectile function after radical prostatectomy in prostate cancer patients.