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

Clinicaltrials.gov ID: NCT05842057

Status RECRUITING

Phase PHASE2

Age 40 - 80 Years

Enrollments 240

Conditions

Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy

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.

Locations

1 location Found with status Recruiting

Status

RECRUITING

Contact Person

Sanoj Punnen, MD, MAS
305-243-3246
[email protected]

Principal Investigator

Sanoj Punnen, MD, MAS

Eligibility Criteria

Inclusion Criteria:

1. Men aged 40 to 80 years with localized prostate cancer who are undergoing bilateral nerve-sparing RARP at the University of Miami (UM).

Exclusion Criteria:

1. Men requiring any use of pads for urinary leakage.
2. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED)
3. Men with baseline EPIC26 scores < 60.
4. Previous treatment for prostate cancer.
5. Previous history of pelvic radiation.
6. Patients with impaired decision-making capacity.

Study Plan

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
Description:
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.
PROCEDURE:
Robot-Assisted Radical Prostatectomy
Description:
Robot-assisted surgical removal of the prostate, administered standard of care.

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

Outcome Measures

Primary Outcome Measures

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

Time Frame: Baseline, 12 Months Post-RARP