Clinical trial · Interventional
Nerve Grafting With an Allograft During Radical Prostatectomy - Extended Follow-up in a Prospective Randomized Trial
NCT01770340CI-TRIAL-00050219terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Poor recruitment, Interim analysis: The rates of pts who reached primary and secondary endpoints were lower than expected.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Erectile Dysfunction Following Radical Prostatectomy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radical prostatectomy with implantation of allograft | Biological | — | UNRESOLVED |
| Radical prostatectomy without implantation of allograft | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Control group
- description
- Radical prostatectomy without implantation of allograft
- interventionNames
- Procedure: Radical prostatectomy without implantation of allograft
- type
- EXPERIMENTAL
- label
- Treatment group
- description
- Radical prostatectomy with implantation of allograft
- interventionNames
- Biological: Radical prostatectomy with implantation of allograft
Primary outcomes (1)
- measure
- Erectile function score (IIEF: international index of erectile function) after non nerve sparing radical prostatectomy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.