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

NCT05363644 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 1803935
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Time to continence

  14 days to 12 months post prostatectomy

Study Arms (1)

Single Arm Study Group

EXPERIMENTAL

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

Biological: BioDFence G3

Interventions

BioDFence G3 BIOLOGICAL

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.

Single Arm Study Group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AdventHealth: lead
• Integra LifeSciences Corporation: collaborator

Study Sites (1)

AdventHealth

Celebration, Florida, 34747, United States

Location

Related Publications (11)

• 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.

  PMID: 9149026 BACKGROUND

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

  PMID: 10896513 BACKGROUND

• 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.

  PMID: 10411052 BACKGROUND

• 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.

  PMID: 11061884 BACKGROUND

• 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.

  PMID: 10647798 BACKGROUND

• 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.

  PMID: 25613153 BACKGROUND

• 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.

  PMID: 22260183 BACKGROUND

• 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.

  PMID: 3151296 BACKGROUND

• 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.

  PMID: 13508744 BACKGROUND

• 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.

  PMID: 11377297 BACKGROUND

• 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.

  PMID: 16280816 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Incontinence

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Vipul R Patel, MD

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Vipul R. Patel

Model Details: 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.

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: May 6, 2022
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: June 29, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)