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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Erectile Dysfunction Following Radical Prostatectomy

Intervention / Treatment
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* Biological: Radical prostatectomy with implantation of allograft
* Procedure: Radical prostatectomy without implantation of allograft


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Control group<br>Radical prostatectomy without implantation of allograft | Procedure: Radical prostatectomy without implantation of allograft<br>* No interposition of resected neurvascular bundles<br>|
| Experimental: Treatment group<br>Radical prostatectomy with implantation of allograft | Biological: Radical prostatectomy with implantation of allograft<br>* Interposition of resected neurovascular bundles with allograft Avance®<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radical prostatectomy, erectile function, nerve grafting, allogenic, prostate cancer, Allogenic nerve graft, Time required for nerve grafting