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Prostate CancerPhase 3NCT05363644

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

A Phase 3 study testing BioDFence G3 in people with Prostate Cancer and Prostatectomy, run by AdventHealth at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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

Who is it for?
Ages 40 to 70 years, men only
What is being tested?
BioDFence G3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Apr 2023to 30 Jun 2024
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • AdventHealth

    Celebration, Florida, 34747

Other trials in United States

About this study

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

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

Read the 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.

Being tested
BioDFence G3
Medical subject headings
Prostatic Neoplasms, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioDFence G3Biological

    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.

Study groups in NCT05363644
Study groupRoleWhat they receive
Single Arm Study GroupExperimentalPlacement of a sheet of BioDFence G3 to the neurovascular bundle.
Receives: Biological: BioDFence G3

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to potency

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

    Measured: 14 days to 12 months post prostatectomy

Secondary outcomes (1)

  1. Time to continence

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

    Measured: 14 days to 12 months post prostatectomy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2022
  2. Study start1 Apr 2023 (estimated)
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Jun 2024 (estimated)

Why it stopped: Study was withdrawn due to lack of funding

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05363644
Sponsor's protocol ID
1803935
Status last verified
Jun 2023
First submitted
25 Apr 2022
Last updated
29 Jun 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: De-identified information may be utilized in teachings and/or publication as it related to this research.

Publications

  • 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.

    PubMed 9149026

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

    PubMed 10896513

  • 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.

    PubMed 10411052

  • 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.

    PubMed 11061884

  • 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.

    PubMed 10647798

  • 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.

    PubMed 25613153

  • 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.

    PubMed 22260183

  • 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.

    PubMed 3151296

  • 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.

    PubMed 13508744

  • 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.

    PubMed 11377297

  • 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.

    PubMed 16280816

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BioDFence G3 in people with Prostate Cancer and Prostatectomy, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to potency (time frame: 14 days to 12 months post prostatectomy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05363644, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.

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