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

Prostate Cancer Clinical Trial

— HAMMER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842057
• Other study ID #: 20220852
• Status: Recruiting
• Phase: Phase 2
• Start date: August 24, 2023
• Est. completion date: August 31, 2028

Study information

• Verified date: September 2023
• Source: University of Miami
• Contact: Sanoj Punnen, MD, MAS
• Phone: 305-243-3246
• Email: s.punnen[@]med.miami.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: August 31, 2028
• Est. primary completion date: August 31, 2027
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy
• Prostate Cancer

Intervention

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.

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

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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