Status:
COMPLETED
Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Eligibility:
MALE
Up to 65 years
Phase:
PHASE2
Brief Summary
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 sati...
Detailed Description
OBJECTIVES: * Compare the efficacy of erectile dysfunction rehabilitation and unilateral cavernous nerve-sparing radical prostatectomy with versus without unilateral autologous interposition sural ne...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
111 Patients enrolled
Trial Details
Trial ID
NCT00080808
Start Date
August 1 2001
End Date
July 1 2009
Last Update
July 30 2012
Active Locations (1)
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1
M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009