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

NCT01770340 | Terminated Phase 4 DMC

• 1 other identifier: KEK-ZH-NR:2010-0004/0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Erectile Dysfunction Following Radical Prostatectomy

Keywords

radical prostatectomy; erectile function; nerve grafting; allogenic; prostate cancer; Allogenic nerve graft; Time required for nerve grafting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  24 months

Other Outcomes (1)

• Documented will be the extra time required for the nerve implantation

  at the time of operation

Study Arms (2)

Control group

SHAM COMPARATOR

Radical prostatectomy without implantation of allograft

Procedure: Radical prostatectomy without implantation of allograft

Treatment group

EXPERIMENTAL

Radical prostatectomy with implantation of allograft

Biological: Radical prostatectomy with implantation of allograft

Interventions

Radical prostatectomy with implantation of allograft BIOLOGICAL

Interposition of resected neurovascular bundles with allograft Avance®

Treatment group

Radical prostatectomy without implantation of allograft PROCEDURE

No interposition of resected neurvascular bundles

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kantonsspital Winterthur KSW: lead

Study Sites (1)

Kantonsspital Winterthur

Winterthur, Canton of Zurich, 8401, Switzerland

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Hubert John, Chefarzt

  Kantonsspital Winterthur KSW

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2012
• First Posted: January 17, 2013
• Study Start: January 1, 2011
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2020
• Last Updated: February 21, 2021

Record last verified: 2021-02

Locations

CH (1)