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


Phase 4
18 Years
N/A
Open (Enrolling)
Male
Erectile Dysfunction Following Radical Prostatectomy

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Trial Information

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


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-5).

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.


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-5).

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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy

Outcome Description:

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

Outcome Time Frame:

24 months

Safety Issue:

No

Principal Investigator

Hubert John, Chefarzt

Investigator Role:

Principal Investigator

Investigator Affiliation:

Kantonsspital Winterthur KSW

Authority:

Switzerland: Ethikkommission

Study ID:

KEK-ZH-NR:2010-0004/0

NCT ID:

NCT01770340

Start Date:

January 2011

Completion Date:

January 2014

Related Keywords:

  • Erectile Dysfunction Following Radical Prostatectomy
  • radical prostatectomy
  • erectile function
  • nerve grafting
  • allogenic
  • prostate cancer
  • Allogenic nerve graft
  • Time required for nerve grafting
  • Erectile Dysfunction

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