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

University of Miami

Status and phase: Enrolling; Phase 2

Conditions: Erectile Dysfunction Following Radical Prostatectomy; Prostate Cancer

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05842057

20220852

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: Male

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 2 patient groups

Membrane Arm: dHACM Group

Experimental 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.

Treatment:

Biological: BioDFence G3 Placental Tissue Membrane

Procedure: Robot-Assisted Radical Prostatectomy

Control Arm: No dHACM Group

Other 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.

Treatment:

Procedure: Robot-Assisted Radical Prostatectomy