Clinical trial · Interventional
Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy
Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
NCT05842057CI-TRIAL-00117968HAMMERactive not recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioDFence G3 Placental Tissue Membrane | Biological | — | UNRESOLVED |
| Robot-Assisted Radical Prostatectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Membrane Arm: dHACM Group
- description
- 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.
- interventionNames
- Biological: BioDFence G3 Placental Tissue Membrane
- Procedure: Robot-Assisted Radical Prostatectomy
- type
- OTHER
- label
- Control Arm: No dHACM Group
- description
- 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.
- interventionNames
- Procedure: Robot-Assisted Radical Prostatectomy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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 with complete, bilateral nerve resection. 4. Previous treatment for prostate cancer. 5. Previous history of pelvic radiation. 6. Patients with impaired decision-making capacity.
References
Publications (0)
Data not yet available
No reference posted for this study.