Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy

NCT05842057 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 20220852
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy

Keywords

Prostatectomy; Allograft Membrane

Outcome Measures

Primary Outcomes (1)

• Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score

  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.

  Baseline, 12 Months Post-RARP

Secondary Outcomes (8)

• Change in Erectile Function Recovery as Measured by SHIM Score

  Baseline, 12 Months Post-RARP

• Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score

  Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

• Change in Proportion of Participants with mild ED or Better as Defined by SHIM Score

  Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

• Change in Proportion of Participants with Erections Adequate for Penetration ≥ 50% of the time

  Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

• Change in Proportion of Participants who Require the Use of More Invasive Erectile Aids

  Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP

Study Arms (2)

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.

Biological: BioDFence G3 Placental Tissue Membrane; Procedure: Robot-Assisted Radical Prostatectomy

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.

Procedure: Robot-Assisted Radical Prostatectomy

Interventions

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.

Also known as: Dehydrated Human Amnion Chorion Membrane (dHACM), Human Amnion Membrane Allograft

Membrane Arm: dHACM Group

Robot-Assisted Radical Prostatectomy PROCEDURE

Robot-assisted surgical removal of the prostate, administered standard of care.

Also known as: RARP

Control Arm: No dHACM Group; Membrane Arm: dHACM Group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Men aged 40 to 80 years with localized prostate cancer who are undergoing RARP at the University of Miami (UM).

You may not qualify if:

• Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED).
• Men with baseline EPIC26 scores \< 50.
• Patients with complete, bilateral nerve resection.
• Previous treatment for prostate cancer.
• Previous history of pelvic radiation.
• Patients with impaired decision-making capacity.

Sponsors & Collaborators

• University of Miami: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Sanoj Punnen, MD, MAS

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants will be blinded to the treatment they receive. To minimize bias on the surgical team during the nerve sparing process, the surgical team will be blinded to arm allocation until after the prostate is removed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: April 24, 2023
• First Posted: May 3, 2023
• Study Start: August 24, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)