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

Phase 4

Completed

• Conditions: Cavernous Nerve Injury; Peripheral Nerve Injury; Radical Prostatectomy; Nerve Reconstruction; Prostate Cancer
• Interventions: Other: Processed Human Nerve Tissue Scaffold

• Registration Number: NCT00953277
• Lead Sponsor: Axogen Corporation

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-04
• Study First Submitted QC: 2009-08-05
• Study First Posted: 2009-08-06
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avance Nerve Graft	Processed Human Nerve Tissue Scaffold	Processed Human Nerve Tissue Scaffold

Primary Outcome Measures

Name	Time	Method
Surgeon Assessment of Technical Feasibility	At time of surgery

Secondary Outcome Measures

Name	Time	Method
Erectile Recovery Rates	Month 1, 3, 6, 9, 12, 18 and 24
Adverse Events	Month 1, 3, 6, 9, 12, 18 and 24
Quality of Life Questionnaire	Month 1, 3, 6, 9, 12, 18 and 24
Continence Rates	Month 1, 3, 6, 9, 12, 18 and 24

Trial Locations

Locations (1)

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States