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

Phase 4

Terminated

• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Interventions: Biological: Radical prostatectomy with implantation of allograft; Procedure: Radical prostatectomy without implantation of allograft

• Registration Number: NCT01770340
• Lead Sponsor: Kantonsspital Winterthur KSW

Brief 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.

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-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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2012-12-13
• Study First Submitted QC: 2013-01-15
• Study First Posted: 2013-01-17
• Primary Completion: 2017-04
• Study Completion: 2020-07-01
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-18
• Last Update Posted: 2021-02-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 30

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).

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Radical prostatectomy with implantation of allograft	Radical prostatectomy with implantation of allograft
Control group	Radical prostatectomy without implantation of allograft	Radical prostatectomy without implantation of allograft

Primary Outcome Measures

Name	Time	Method
Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy	24 months	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

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	24 months	Monitoring of side effects and complications in connection with the nerve-implantation.

Trial Locations

Locations (1)

Kantonsspital Winterthur; 🇨🇭 Winterthur, Kanton Zürich, Switzerland