Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

A Pilot Study to Assess the Technical Feasibility of Robotic Assisted Laparoscopic Interpositioning of the AVANCETM Nerve Graft for Reconstruction of the Neurovascular Bundle, With a Twenty-four Month Follow-up Term to Assess Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00953277
• Other study ID #: ANG-CP-003
• Status: Completed
• Phase: Phase 4
• First received: August 4, 2009
• Last updated: May 20, 2015
• Start date: August 2009
• Est. completion date: April 2015

Study information

• Verified date: May 2015
• Source: AxoGen, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if it is technically feasable to repair nerves that are injured as part of a planned surgical removal of the prostate and the surrounding tissue in subjects with prostate cancer. The study will also examine the long term outcomes on erectile function, continence and overall quality of life in the enrolled subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• = 18 years of age, but =70 years of age;

• IIEF EF Domain*1 score = 22;

• be able to effectively communicate with study personnel;

• be considered by the physician to be available for subsequent visits;

• be willing to comply with all aspects of the treatment and evaluation schedule over a 24 month duration;

• sign and date an IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures; and

• require radical prostatectomy.

Exclusion Criteria:

• prior surgery in the last 6 months which could affect sexual function;

• history of Peyronie's disease;

• significant neurological disorder (i.e. multiple sclerosis, peripheral neuropathy);

• treatment for major psychiatric disorders;

• history of penile implant or prosthesis;

• history of diabetic neuropathy;

• life expectancy of less than two years;

• concurrently involved in another investigational study;

• uncontrolled hypertension with systolic BP >200mmHg or diastolic BP >115mmHg is present at screening;

• currently receiving or planned treatment with chemotherapy or radiation therapy;

• diagnosis of bony metastasis;

• known allergy or severe intolerance to PDE-5 inhibitors; or

• cardiac pacing equipment or other electro-mechanical devices which preclude the use of CaverMap™ neurostimulator.

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cavernous Nerve Injury
• Nerve Reconstruction
• Peripheral Nerve Injuries
• Peripheral Nerve Injury
• Prostate Cancer
• Prostatic Neoplasms
• Radical Prostatectomy

Intervention

Other:
• Processed Human Nerve Tissue Scaffold
Implantation of appropriate length of processed human nerve scaffold at the time of surgery.

Locations

Country	Name	City	State
United States	Vanderbilt University	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
AxoGen, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgeon Assessment of Technical Feasibility		At time of surgery	Yes
Secondary	Erectile Recovery Rates		Month 1, 3, 6, 9, 12, 18 and 24	No
Secondary	Continence Rates		Month 1, 3, 6, 9, 12, 18 and 24	No
Secondary	Quality of Life Questionnaire		Month 1, 3, 6, 9, 12, 18 and 24	No
Secondary	Adverse Events		Month 1, 3, 6, 9, 12, 18 and 24	Yes