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

• Sponsor: University of Miami (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05842057
• Collaborator: Integra LifeSciences Corporation (Industry)
• Enrollment: 240
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy	Biological: BioDFence G3 Placental Tissue Membrane; Procedure: Robot-Assisted Radical Prostatectomy	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 240 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Masking Description: 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.
• Primary Purpose: Supportive Care
• Official Title: Phase 2 Randomized Trial: Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy (HAMMER)
• Anticipated Study Start Date: Jun 30, 2023
• Anticipated Primary Completion Date: Jun 30, 2027
• Anticipated Study Completion Date: Jun 30, 2028

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Erectile Function Recovery as Measured by EPIC26 Sexual Domain Score [Baseline, 12 Months Post-RARP]

   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.

Secondary Outcome Measures

1. Change in Erectile Function Recovery as Measured by SHIM Score [Baseline, 12 Months Post-RARP]

   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.

2. 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]

   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.

3. 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]

   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.

4. 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]

   Proportion of participants with erections adequate for penetration greater than or equal to 50-percent of the time.

5. 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]

   Proportion of participants who require the use of more invasive erectile aids (intra-cavernosal injection, vacuum pump, or penile prosthesis).

6. Change in Rate of Urinary Control [Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP]

   Rate of urinary control as measured by EPIC26 question 3 that reports the number of participants requiring no pads per day.

7. Change in Biochemical Failure [Baseline, 3 months, 6 months, 9 months, 12 months Post-RARP]

   Biochemical failure among participants will measured as a prostate-specific antigen (PSA) level > 0.2 ng/ml on two consecutive samples.

8. Number of Treatment-Related Adverse Events [Up to 12 months post-RARP]

   The number of treatment-related adverse events among participants will be assessed by treating physician using the Clavien-Dindo grading scale.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• Integra LifeSciences Corporation

Investigators

• Principal Investigator: Sanoj Punnen, MD, MAS, University of Miami

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sanoj Punnen, MD, MAS, Associate Professor of Clinical, University of Miami
• ClinicalTrials.gov Identifier: NCT05842057
• Other Study ID Numbers: 20220852
• First Posted: May 3, 2023
• Last Update Posted: May 3, 2023
• Last Verified: Apr 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Sanoj Punnen, MD, MAS, Associate Professor of Clinical, University of Miami: Prostatectomy; Allograft Membrane
• Additional relevant MeSH terms: Erectile Dysfunction

Study Results

No Results Posted as of May 3, 2023