Clinical trial NCT01770340: Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
Official title: Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Erectile Dysfunction Following Radical Prostatectomy
Keywords: radical prostatectomy
erectile function
nerve grafting
allogenic
prostate cancer
Allogenic nerve graft
Time required for nerve grafting
Lead sponsor: Kantonsspital Winterthur KSW
Sponsor class: OTHER
First posted: 2013-01-17
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy
timeFrame: 24 months
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 24 months
Other outcomes:
measure: Documented will be the extra time required for the nerve implantation
timeFrame: at the time of operation
Locations:
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
state: Kanton Zürich
Study officials:
affiliation: Kantonsspital Winterthur KSW
name: Hubert John, Chefarzt
role: PRINCIPAL_INVESTIGATOR
References: