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

Kantonsspital Winterthur KSW

Status and phase: Terminated; Phase 4

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Treatments: Biological: Radical prostatectomy with implantation of allograft; Procedure: Radical prostatectomy without implantation of allograft

Study type: Interventional

Funder types: Other

Identifiers

NCT01770340

KEK-ZH-NR:2010-0004/0

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Control group

Sham Comparator group

Description:

Radical prostatectomy without implantation of allograft

Treatment:

Procedure: Radical prostatectomy without implantation of allograft

Treatment group

Experimental group

Description:

Radical prostatectomy with implantation of allograft

Treatment:

Biological: Radical prostatectomy with implantation of allograft