Human Amnion Membrane Allograft and Early Return of Erectile Function After Radical Prostatectomy - Clinical Trial for Prostate Cancer | NCT05842057

Back to results

Primary Purpose

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

BioDFence G3 Placental Tissue Membrane

Robot-Assisted Radical Prostatectomy

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Prostatectomy, Allograft Membrane

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept 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: Men requiring any use of pads for urinary leakage. Men requiring the use of any non-oral erectile aids for erectile dysfunction (ED) Men with baseline EPIC26 scores < 60. Previous treatment for prostate cancer. Previous history of pelvic radiation. Patients with impaired decision-making capacity.

Sites / Locations

University of MiamiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Membrane Arm: dHACM Group

Control Arm: No dHACM Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

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).

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.

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.

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.

Full Information

NCT ID

NCT05842057

First Posted

April 24, 2023

Last Updated

September 14, 2023

Sponsor

University of Miami

Collaborators

Integra LifeSciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05842057

Brief Title

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

Acronym

HAMMER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 24, 2023 (Actual)

Primary Completion Date

August 31, 2027 (Anticipated)

Study Completion Date

August 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Miami

Collaborators

Integra LifeSciences Corporation

4. Oversight

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

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer, Erectile Dysfunction Following Radical Prostatectomy

Keywords

Prostatectomy, Allograft Membrane

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare 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.

Allocation

Randomized

Enrollment

240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Membrane Arm: dHACM Group

Arm Type

Experimental

Arm 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.

Arm Title

Control Arm: No dHACM Group

Arm Type

Other

Arm 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.

Intervention Type

Biological

Intervention Name(s)

BioDFence G3 Placental Tissue Membrane

Other Intervention Name(s)

Dehydrated Human Amnion Chorion Membrane (dHACM), Human Amnion Membrane Allograft

Intervention 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.

Intervention Type

Procedure

Intervention Name(s)

Robot-Assisted Radical Prostatectomy

Other Intervention Name(s)

RARP

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline, 12 Months Post-RARP

Secondary Outcome Measure Information:

Title

Change in Erectile Function Recovery as Measured by SHIM Score

Description

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.

Time Frame

Baseline, 12 Months Post-RARP

Title

Change in Proportion of Men with Mild ED or Better as Defined by EPIC26 Sexual Domain Score

Description

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.

Time Frame