BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy

Phase 3

Withdrawn

• Conditions: Prostatectomy; Prostate Cancer; Erectile Dysfunction Following Radical Prostatectomy; Incontinence, Urinary
• Interventions: Biological: BioDFence G3

• Registration Number: NCT05363644
• Lead Sponsor: AdventHealth

Brief Summary

The purpose of this study is to assess functional outcomes post operatively after the use of BioDFence® G3 during robotic radical prostatectomy.

Detailed Description

The purpose of this study is to build on our experience of amniotic membrane use in Robotic Assisted Radical Prostatectomy for prostate cancer, we aim to evaluate clinical outcomes related to the use of BioDFence® G3; a tri-layered amniotic membrane. BioDFence® G3 is regulated by the FDA as a 361 HCT/P for use from head to toe as a tissue barrier for soft tissue repair and as a wound covering.

For the purpose of this study BioDFence® G3 will be placed on the neurovascular bundles by the surgeon during the robotic assisted radical prostatectomy procedure that the participant has elected as their primary treatment for prostate cancer. The potential benefits that will be assessed are an earlier return of potency after surgery as evidenced by The Sexual Health Inventory for Men (SHIM) questionnaire score and self-reported sexual function and secondarily looking at continence outcomes measured by The American Urological Association (AUA) questionnaire form and self-reported urinary function.

Study Timeline

• Study First Submitted: 2022-04-25
• Study First Submitted QC: 2022-05-02
• Study First Posted: 2022-05-06
• Study Start: 2023-04-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Male subjects between the ages 40-70.
2. Primary diagnosis of prostate cancer requiring surgical intervention
3. Have a willingness to comply with follow-up requirements.
4. Have ability to provide full written consent.
5. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or 7.
6. Planned elective radical prostatectomy with bilateral full nerve sparing technique.
7. Patients who currently have a pre-operative SHIM > 19

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Exclusion Criteria

1. Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.

2. Has any condition(s), which seriously compromises the subject's ability to participate in this study or has a known history of poor adherence with medical treatment.

3. Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including:

   1. Diabetes Type I or Type II
   2. Advanced atherosclerotic vascular disease

4. Is unable to sign or understand informed consent.

5. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.

6. Has a documented medical history of drug or alcohol abuse within last 12 months.

7. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.

8. Known sensitivity to glutaraldehyde or ethanol.

9. Patients with a history of more than two weeks treatment with immuno-suppressants (including systemic corticosteroids), cytotoxic chemotherapy within one month prior to initial screening, or who receive such medications during the screening period, or who are anticipated to require such medications during the course of the study.

10. Has had prior hormonal therapy such as Lupron or oral anti-androgens.

11. Living outside of United States

12. Partial nerve sparing technique used during Radical Prostatectomy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm Study Group	BioDFence G3	Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Primary Outcome Measures

Name	Time	Method
Time to potency	14 days to 12 months post prostatectomy	Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.

Secondary Outcome Measures

Name	Time	Method
Time to continence	14 days to 12 months post prostatectomy	Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily.

Trial Locations

Locations (1)

AdventHealth; 🇺🇸 Celebration, Florida, United States