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

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05363644
• Other study ID #: 1803935
• Status: Withdrawn
• Phase: Phase 3
• Start date: April 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: June 2023
• Source: AdventHealth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

Biological:
• BioDFence G3
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.

Locations

Country	Name	City	State
United States	AdventHealth	Celebration	Florida

Sponsors (2)

Lead Sponsor	Collaborator
AdventHealth	Integra LifeSciences Corporation

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to potency	Outcome measured by the Sexual Health Inventory for Men (SHIM) score and patient reported potency erectile function score.	14 days to 12 months post prostatectomy
Secondary	Time to continence	Outcome measured by the American Urological Association (AUA ) score and patient reported number of urinary sanitation pads used daily.	14 days to 12 months post prostatectomy