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

NCT00953277 | Completed Phase 4

• 1 other identifier: ANG-CP-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Nerve Injury; Prostate Cancer; Radical Prostatectomy; Nerve Reconstruction; Cavernous Nerve Injury

Keywords

Nerve Repair; Erectile Function; Prostate Cancer; Robot Assisted Laparoscopic Prostatectomy; Continence

Outcome Measures

Primary Outcomes (1)

• Surgeon Assessment of Technical Feasibility

  At time of surgery

Secondary Outcomes (4)

• Erectile Recovery Rates

  Month 1, 3, 6, 9, 12, 18 and 24

• Continence Rates

  Month 1, 3, 6, 9, 12, 18 and 24

• Quality of Life Questionnaire

  Month 1, 3, 6, 9, 12, 18 and 24

• Adverse Events

  Month 1, 3, 6, 9, 12, 18 and 24

Study Arms (1)

Avance Nerve Graft

EXPERIMENTAL

Processed Human Nerve Tissue Scaffold

Other: Processed Human Nerve Tissue Scaffold

Interventions

Processed Human Nerve Tissue Scaffold OTHER

Implantation of appropriate length of processed human nerve scaffold at the time of surgery.

Avance Nerve Graft

Eligibility Criteria

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

You may qualify if:

• ≥ 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Axogen Corporation: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Peripheral Nerve Injuries; Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Joseph J Smith, MD

  Vanderbilt Univerisity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: August 1, 2009
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 12, 2024

Record last verified: 2024-08

Locations

US (1)