Clinical trial · Interventional
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
A Randomized Phase II Trial Evaluating the Importance of Early Erectile Dysfunction Rehabilitation and Unilateral Autologous Sural Nerve Sparing Radical Prostatectomy Clinically Localized Prostate Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Nerve-sparing radical prostatectomy with nerve grafting followed by standard therapies for erectile dysfunction may be effective in helping patients with prostate cancer improve sexual satisfaction and quality of life. It is not yet known whether erectile dysfunction therapy and nerve-sparing prostatectomy are more effective with or without nerve grafting. PURPOSE: This randomized phase II trial is studying nerve grafting and standard therapy to see how well they work compared to standard therapy alone in treating erectile dysfunction in patients undergoing nerve-sparing radical prostatectomy for localized prostate cancer.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alprostadil (E1) | Drug | — | UNRESOLVED |
| conventional surgery | Procedure | — | UNRESOLVED |
| Papaverine | Drug | — | UNRESOLVED |
| Phentolamine mesylate | Drug | — | UNRESOLVED |
| Sildenafil citrate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I
- description
- Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.
- interventionNames
- Drug: Alprostadil (E1)
- Drug: Papaverine
- Drug: Phentolamine mesylate
- Drug: Sildenafil citrate
- Procedure: conventional surgery
- type
- ACTIVE_COMPARATOR
- label
- Arm II (No sural nerve grafting)
- description
- Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.
- interventionNames
- Drug: Alprostadil (E1)
- Drug: Papaverine
- Drug: Phentolamine mesylate
- Drug: Sildenafil citrate
- Procedure: conventional surgery
Eligibility
Eligibility (as posted)
- Sex
- Male
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patient must be a candidate for a unilateral nerve sparing radical retropubic prostatectomy. a) Gleason score 7 or less in the cores on the side to be spared 2. Patient must have no discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts. 3. Patient must be \</= 65 years of age at the time of study enrollment. 4. Patient must have no peripheral neuropathy precluding procurement of a sural nerve graft 5. Patient must have no significant psychiatric illness or demonstrable vasculogenic source of impotence. 6. No prior history of pelvic irradiation or androgen deprivation therapy (LHRH agonists or anti-androgens) Exclusion Criteria:
References
Publications (1)
- RESULTDavis JW, Chang DW, Chevray P, Wang R, Shen Y, Wen S, Pettaway CA, Pisters LL, Swanson DA, Madsen LT, Huber N, Troncoso P, Babaian RJ, Wood CG. Randomized phase II trial evaluation of erectile function after attempted unilateral cavernous nerve-sparing retropubic radical prostatectomy with versus without unilateral sural nerve grafting for clinically localized prostate cancer. Eur Urol. 2009 May;55(5):1135-43. doi: 10.1016/j.eururo.2008.08.051. Epub 2008 Sep 2. PMID 18783876