Clinical trial NCT00953277: Study of Nerve Reconstruction Using AVANCE in Subjects Who Undergo Robotic Assisted Prostatectomy for Treatment of Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
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
Lead sponsor: Axogen Corporation
Sponsor class: INDUSTRY
First posted: 2009-08-06
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Surgeon Assessment of Technical Feasibility
timeFrame: At time of surgery
Secondary outcomes:
measure: Erectile Recovery Rates
timeFrame: Month 1, 3, 6, 9, 12, 18 and 24
measure: Continence Rates
timeFrame: Month 1, 3, 6, 9, 12, 18 and 24
measure: Quality of Life Questionnaire
timeFrame: Month 1, 3, 6, 9, 12, 18 and 24
measure: Adverse Events
timeFrame: Month 1, 3, 6, 9, 12, 18 and 24
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt Univerisity
name: Joseph J Smith, MD
role: PRINCIPAL_INVESTIGATOR
References: