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

Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Biological: BioDFence G3 Placental Tissue Membrane; Procedure: Robot-Assisted Radical Prostatectomy

• Study Type: Interventional
• Enrollment (Estimated): 240
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Sanoj Punnen, MD, MAS; Phone Number: 305-243-3246; Email: s.punnen@med.miami.edu
• Study Contact Backup: Name: Elena M Cortizas; Phone Number: +1 (305) 243-6438; Email: ecortizas@med.miami.edu

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
      • Principal Investigator: Sanoj Punnen, MD, MAS
      • Contact: Sanoj Punnen, MD, MAS; Phone Number: 305-243-3246; Email: s.punnen@med.miami.edu
      • Contact: Elena M Cortizas; Phone Number: 305-243-6438; Email: ecortizas@med.miami.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Membrane Arm: dHACM Group; 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; 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.; Other Names: Dehydrated Human Amnion Chorion Membrane (dHACM); Human Amnion Membrane Allograft; Procedure: Robot-Assisted Radical Prostatectomy; Robot-assisted surgical removal of the prostate, administered standard of care.; Other Names: RARP
Other: Control Arm: No dHACM Group; 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; Robot-assisted surgical removal of the prostate, administered standard of care.; Other Names: RARP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Erectile Function Recovery as Measured by SHIM Score	Erectile function recovery among participants will be measured as the change in Sexual History Inventory for Men (SHIM). The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.	Baseline, 12 Months Post-RARP
Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score	Proportion of men with mild ED or better as defined by an EPIC26 Sexual Domain score greater than or equal to 60. 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 sexual function.	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	Proportion of participants with mild ED or better as defined by a SHIM score greater than or equal to 17. The SHIM is a health-related quality of life (HRQOL) questionnaire whose scores measure the severity of erectile dysfunction (ED) in men using points on a scale. The minimum score of 1 to 7 points indicates severe ED; a score of 8 to 11 points indicates moderate ED; a score of 12 to 15 points indicates mild-to-moderate ED; a score of 17 to 21 points indicates mild ED; and the maximum score of 22 to 25 points indicates no significant ED.	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	Proportion of participants with erections adequate for penetration greater than or equal to 50-percent 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	Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis).	Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Rate of Urinary Control	Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day.	Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Change in Biochemical Failure	Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level > 0.2 ng/ml on two consecutive samples.	Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP
Number of Treatment-Related Adverse Events	The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale.	Up to 12 months post-RARP

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Sanoj Punnen, MD, MAS, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2023
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: April 24, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Prostatectomy; Allograft Membrane
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: 20220852

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No