Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Kantonsspital Winterthur KSW
Sponsor:
Information provided by (Responsible Party):
Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier:
NCT01770340
First received: December 13, 2012
Last updated: January 21, 2013
Last verified: January 2013
  Purpose

Earlier studies were able to show that an improvement of the erectile function following a non-nerve sparing radical prostatectomy could be achieved using an autologous nerve graft.

The investigators evaluate the use of the implantation of the allogenic nerve graft Avance® in patients undergoing non nerve-sparing radical prostatectomy.


Condition Intervention Phase
Erectile Dysfunction Following Radical Prostatectomy
Biological: Implantation of allogenic nerve graft
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial

Resource links provided by NLM:


Further study details as provided by Kantonsspital Winterthur KSW:

Primary Outcome Measures:
  • Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy. To show a complete impotence in the control group and an enhancement of the initial postoperative impotence in the treatment group


Secondary Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    Monitoring of side effects and complications in connection with the nerve-implantation.


Other Outcome Measures:
  • Documented will be the extra time required for the nerve implantation [ Time Frame: at the time of operation ] [ Designated as safety issue: No ]
    How much operation-time takes the nerve implantation? The time is stopped which is required for the implantation of the nerve. Start is when the prostate was removed and was deposited in the extraction bag. Stop when the anastomosis of the nerves is stitched and the anastomosis of the urethra begins.


Estimated Enrollment: 60
Study Start Date: January 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: control group
radical prostatectomy without implantation of the allogenic nerve
Active Comparator: treatment group
radical prostatectomy with implantation of allogenic nerve graft
Biological: Implantation of allogenic nerve graft
radical prostatectomy with implantation of allogenic nerve graft

Detailed Description:

In this prospective randomised and single-blind, clinical phase-IV study, 60 patients are randomized into the treatment group and the control group. The follow-up is at least 24 months.

The inclusion criteria were localized prostate cancers cT3 and/or Gleason score ≥ 7 (a or b) and/or prostate-specific antigen (PSA) ≥ 20 ng/ml and furthermore an erectile function with an IIEF ≥ 21 (IIEF-5).

The operation carried out is a standardised, robot assisted laparoscopic radical prostatectomy with total excision of both neurovascular bundles.

The Outcome measurement is done with the "quality of life questionnaire before and after prostate surgery" that includes the "International Index of Erectile Function" (IIEF) questionnaire.

The limitations are a small cohort, a short observation period and the lack of statistical analysis due to a still low number of patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Localized intermediate-risk or high-risk prostate cancer cT3
  • Gleason score ≥ 7 (3+4 and/or 4+3) and/or
  • PSA ≥ 20 ng/ml
  • intact preoperative erectile function with an IIEF ≥ 21 (IIEF-5).

Exclusion Criteria:

  • IIEF < 21
  • Operations in the past 6 months which could limit the erectile function
  • Erectile dysfunction in the history or current medication for erectile dysfunction
  • Current involvement in another comparable study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01770340

Locations
Switzerland
Kantonsspital Winterthur Recruiting
Winterthur, Kanton Zürich, Switzerland, 8401
Contact: Hubert John, Chefarzt    +41 52 266 2982    hubert.john@ksw.ch   
Sponsors and Collaborators
Kantonsspital Winterthur KSW
Investigators
Principal Investigator: Hubert John, Chefarzt Kantonsspital Winterthur KSW
  More Information

No publications provided

Responsible Party: Kantonsspital Winterthur KSW
ClinicalTrials.gov Identifier: NCT01770340     History of Changes
Other Study ID Numbers: KEK-ZH-NR:2010-0004/0
Study First Received: December 13, 2012
Last Updated: January 21, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by Kantonsspital Winterthur KSW:
radical prostatectomy
erectile function
nerve grafting
allogenic
prostate cancer
Allogenic nerve graft
Time required for nerve grafting

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014