Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
Completed · Phase 2
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT00080808
- Run by
- M.D. Anderson Cancer Center
- People needed
- 111
- Starts
- 2001-08-01
- Expected to finish
- 2009-07-01
- Last updated by the study team
- 2012-07-30
Who can join
Age: any, up to 65. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Patient must have no discernable preoperative erectile dysfunction, defined as the ability to have successful penetration on at least 75% of attempts.
- Patient must be </= 65 years of age at the time of study enrollment.
- Patient must have no peripheral neuropathy precluding procurement of a sural nerve graft
- Patient must have no significant psychiatric illness or demonstrable vasculogenic source of impotence.
- No prior history of pelvic irradiation or androgen deprivation therapy (LHRH agonists or anti-androgens)
Where it is running
- M.D. Anderson Cancer Center at University of Texas — Houston, Texas, United States
Full record on ClinicalTrials.gov
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