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

Erectile Dysfunction Following Radical Prostatectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01770340
• Other study ID #: KEK-ZH-NR:2010-0004/0
• Status: Terminated
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: July 1, 2020

Study information

• Verified date: February 2021
• Source: Kantonsspital Winterthur KSW
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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-6).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. completion date: July 1, 2020
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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-6).

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.

Related Conditions & MeSH terms

• Erectile Dysfunction
• Erectile Dysfunction Following Radical Prostatectomy

Intervention

Biological:
• Radical prostatectomy with implantation of allograft
Interposition of resected neurovascular bundles with allograft Avance®

Procedure:
• Radical prostatectomy without implantation of allograft
No interposition of resected neurvascular bundles

Locations

Country	Name	City	State
Switzerland	Kantonsspital Winterthur	Winterthur	Kanton Zürich

Sponsors (1)

Lead Sponsor	Collaborator
Kantonsspital Winterthur KSW

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Documented will be the extra time required for the nerve implantation	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.	at the time of operation
Primary	Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy	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	24 months
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability	Monitoring of side effects and complications in connection with the nerve-implantation.	24 months