Prostate Cancer Clinical Trial
Official title:
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
Verified date | July 2012 |
Source | M.D. Anderson Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | July 2009 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | N/A to 65 Years |
Eligibility |
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: |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | M.D. Anderson Cancer Center at University of Texas | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Cancer Institute (NCI) |
United States,
Davis 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 re — View Citation
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Primary | Potency rate at 2 years after surgery | 2 years | No |
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