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Clinical Trials (PDQ®)

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

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVTreatmentClosed18 to 70Pharmaceutical / IndustryANG-CP-003
NCT00953277

Trial Description

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.

Trial Contact Information

Trial Lead Organizations/Sponsors

AxoGen, Incorporated

Joseph A. SmithPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00953277
ClinicalTrials.gov processed this data on August 01, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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