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

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.

Study Overview

• Status: Terminated
• Conditions: Erectile Dysfunction Following Radical Prostatectomy
• Intervention / Treatment: Procedure: Radical prostatectomy without implantation of allograft; Biological: Radical prostatectomy with implantation of allograft

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Kanton Zürich
    • Winterthur, Kanton Zürich, Switzerland, 8401
      • Kantonsspital Winterthur

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
SHAM_COMPARATOR: Control group; Radical prostatectomy without implantation of allograft	Procedure: Radical prostatectomy without implantation of allograft; No interposition of resected neurvascular bundles
EXPERIMENTAL: Treatment group; Radical prostatectomy with implantation of allograft	Biological: Radical prostatectomy with implantation of allograft; Interposition of resected neurovascular bundles with allograft Avance®

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Kantonsspital Winterthur KSW
• Investigators: Principal Investigator: Hubert John, Chefarzt, Kantonsspital Winterthur KSW

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): April 1, 2017
• Study Completion (ACTUAL): July 1, 2020

Study Registration Dates

• First Submitted: December 13, 2012
• First Submitted That Met QC Criteria: January 15, 2013
• First Posted (ESTIMATE): January 17, 2013

Study Record Updates

• Last Update Posted (ACTUAL): February 21, 2021
• Last Update Submitted That Met QC Criteria: February 18, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: prostate cancer; radical prostatectomy; nerve grafting; allogenic; erectile function; Allogenic nerve graft; Time required for nerve grafting
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction
• Other Study ID Numbers: KEK-ZH-NR:2010-0004/0