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

Primary Purpose

Prostate Cancer, Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

BioDFence G3

About this trial

This is an interventional prevention trial for Prostate Cancer

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past.
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.
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
Is unable to sign or understand informed consent.
Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor.
Has a documented medical history of drug or alcohol abuse within last 12 months.
Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV.
Known sensitivity to glutaraldehyde or ethanol.
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.
Has had prior hormonal therapy such as Lupron or oral anti-androgens.
Living outside of United States
Partial nerve sparing technique used during Radical Prostatectomy

Sites / Locations

AdventHealth

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm Study Group

Arm Description

Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Outcomes

Primary Outcome Measures

Time to potency

Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.

Secondary Outcome Measures

Time to continence

Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily.

Full Information

NCT ID

NCT05363644

First Posted

April 25, 2022

Last Updated

June 28, 2023

Sponsor

AdventHealth

Collaborators

Integra LifeSciences Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05363644

Brief Title

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

Official Title

Treatment Protocol With BioDFence® G3 For Full Nerve-Sparing Robotic-Assisted Radical Prostatectomy: A Prospective Open Label Single-Center Study

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Study was withdrawn due to lack of funding

Study Start Date

April 1, 2023 (Anticipated)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

AdventHealth

Collaborators

Integra LifeSciences Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Prostate Cancer, Prostatectomy, Erectile Dysfunction Following Radical Prostatectomy, Incontinence, Urinary

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Model Description

All of the patients will be recruited from patients seen in the principal investigator's (PI's) hospital and practice. The offer to participate will be extended to all eligible subjects for the importance of a representative sample. No women, children or prisoners will be enrolled in this study.

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single Arm Study Group

Arm Type

Experimental

Arm Description

Placement of a sheet of BioDFence G3 to the neurovascular bundle.

Intervention Type

Biological

Intervention Name(s)

BioDFence G3

Intervention Description

Placement of a sheet of BioDFence® G3 will be applied to the neurovascular bundle on participants undergoing an elective Full Nerve Sparing Radical Prostatectomy for primary treatment of prostate cancer.

Primary Outcome Measure Information:

Title

Time to potency

Description

Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.

Time Frame

14 days to 12 months post prostatectomy

Secondary Outcome Measure Information:

Title

Time to continence

Description

Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily.

Time Frame

14 days to 12 months post prostatectomy

10. Eligibility

Sex

Male

Gender Based

Yes

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male subjects between the ages 40-70. Primary diagnosis of prostate cancer requiring surgical intervention Have a willingness to comply with follow-up requirements. Have ability to provide full written consent. Primary diagnosis of untreated with clinically localized prostate cancer with Gleason score of 6, or 7. Planned elective radical prostatectomy with bilateral full nerve sparing technique. Patients who currently have a pre-operative SHIM > 19 Exclusion Criteria: Has signs or symptoms of any other disease which could result in allograft failure or has experienced graft failure in the past. 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. Has comorbid conditions that can be confused with or can exacerbate the condition of erectile dysfunction, including: Diabetes Type I or Type II Advanced atherosclerotic vascular disease Is unable to sign or understand informed consent. Is unable to comply with penile rehabilitation, including oral 5-phosphodiesterase inhibitor. Has a documented medical history of drug or alcohol abuse within last 12 months. Has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV. Known sensitivity to glutaraldehyde or ethanol. 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. Has had prior hormonal therapy such as Lupron or oral anti-androgens. Living outside of United States Partial nerve sparing technique used during Radical Prostatectomy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Vipul R Patel, MD

Organizational Affiliation

AdventHealth

Official's Role

Principal Investigator

Facility Information:

Facility Name

AdventHealth

City

Celebration

State/Province

Florida

ZIP/Postal Code

34747

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

De-identified information may be utilized in teachings and/or publication as it related to this research.

Citations:

PubMed Identifier

9149026

Citation

Shrader-Bogen CL, Kjellberg JL, McPherson CP, Murray CL. Quality of life and treatment outcomes: prostate carcinoma patients' perspectives after prostatectomy or radiation therapy. Cancer. 1997 May 15;79(10):1977-86. doi: 10.1002/(sici)1097-0142(19970515)79:103.0.co;2-r.

Results Reference

background

PubMed Identifier

10896513

Citation

Walsh PC. Patient-reported urinary continence and sexual function after anatomic radical prostatectomy. J Urol. 2000 Jul;164(1):242. No abstract available.

Results Reference

background

PubMed Identifier

10411052

Citation

Catalona WJ, Carvalhal GF, Mager DE, Smith DS. Potency, continence and complication rates in 1,870 consecutive radical retropubic prostatectomies. J Urol. 1999 Aug;162(2):433-8.

Results Reference

background

PubMed Identifier

11061884

Citation

Rabbani F, Stapleton AM, Kattan MW, Wheeler TM, Scardino PT. Factors predicting recovery of erections after radical prostatectomy. J Urol. 2000 Dec;164(6):1929-34.

Results Reference

background

PubMed Identifier

10647798

Citation

Stanford JL, Feng Z, Hamilton AS, Gilliland FD, Stephenson RA, Eley JW, Albertsen PC, Harlan LC, Potosky AL. Urinary and sexual function after radical prostatectomy for clinically localized prostate cancer: the Prostate Cancer Outcomes Study. JAMA. 2000 Jan 19;283(3):354-60. doi: 10.1001/jama.283.3.354.

Results Reference

background

PubMed Identifier

25613153

Citation

Patel VR, Samavedi S, Bates AS, Kumar A, Coelho R, Rocco B, Palmer K. Dehydrated Human Amnion/Chorion Membrane Allograft Nerve Wrap Around the Prostatic Neurovascular Bundle Accelerates Early Return to Continence and Potency Following Robot-assisted Radical Prostatectomy: Propensity Score-matched Analysis. Eur Urol. 2015 Jun;67(6):977-980. doi: 10.1016/j.eururo.2015.01.012. Epub 2015 Jan 19.

Results Reference

background

PubMed Identifier

22260183

Citation

Magatti M, De Munari S, Vertua E, Parolini O. Amniotic membrane-derived cells inhibit proliferation of cancer cell lines by inducing cell cycle arrest. J Cell Mol Med. 2012 Sep;16(9):2208-18. doi: 10.1111/j.1582-4934.2012.01531.x.

Results Reference

background

PubMed Identifier

3151296

Citation

Wang TM. [Evaluation of the use of human amnion as a biological dressing]. Zhonghua Zheng Xing Shao Shang Wai Ke Za Zhi. 1986 Dec;2(4):282-3. No abstract available. Chinese.

Results Reference

background

PubMed Identifier

13508744

Citation

DANFORTH D, HULL RW. The microscopic anatomy of the fetal membranes with particular reference to the detailed structure of the amnion. Am J Obstet Gynecol. 1958 Mar;75(3):536-47; discussion 548-50. doi: 10.1016/0002-9378(58)90610-0. No abstract available.

Results Reference

background

PubMed Identifier

11377297

Citation

Walsh PC. Nerve grafts are rarely necessary and are unlikely to improve sexual function in men undergoing anatomic radical prostatectomy. Urology. 2001 Jun;57(6):1020-4. doi: 10.1016/s0090-4295(01)00987-6. No abstract available.

Results Reference

background

PubMed Identifier

16280816

Citation

Menon M, Kaul S, Bhandari A, Shrivastava A, Tewari A, Hemal A. Potency following robotic radical prostatectomy: a questionnaire based analysis of outcomes after conventional nerve sparing and prostatic fascia sparing techniques. J Urol. 2005 Dec;174(6):2291-6, discussion 2296. doi: 10.1097/01.ju.0000181825.54480.eb.

Results Reference

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

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