Nerve-Sparing Radical Prostatectomy With or Without Nerve Grafting Followed by Standard Therapy for Erectile Dysfunction in Treating Patients With Localized Prostate Cancer
NCT ID: NCT00080808
Last Updated: 2012-07-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
111 participants
INTERVENTIONAL
2001-08-31
2009-07-31
Brief Summary
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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.
Detailed Description
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* Compare the efficacy of erectile dysfunction rehabilitation and unilateral cavernous nerve-sparing radical prostatectomy with versus without unilateral autologous interposition sural nerve grafting in patients with clinically localized prostate cancer.
* Compare potency rates in patients treated with these regimens.
* Compare erection quality in patients treated with these regimens.
* Compare time to return of spontaneous erectile activity in patients treated with these regimens.
* Compare the feasibility of these regimens in these patients.
* Compare quality of life and sexual satisfaction in patients treated with these regimens.
* Compare changes in penile erectile length and circumference in patients treated with these regimens.
* Compare the relative morbidity of patients treated with these regimens.
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.
Beginning 6 weeks after surgery, patients undergo erectile dysfunction rehabilitation comprising any of the following: oral sildenafil (as occasion requires), use of vacuum erection device over 10 minutes once daily, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly, or MUSE (suppository in urethra for erections) therapy. Erectile dysfunction rehabilitation may continue for up to 2 years or until return of adequate spontaneous erectile activity.
* Arm II: Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.
In both arms, treatment continues in the absence of unacceptable toxicity.
Quality of life and sexual history are assessed at baseline, at 6 weeks postoperatively, at 4, 8, 12, and 16 months, and then every 4 months for 2 years or until return of spontaneous erectile activity.
Patients are followed every 4 months for 2 years.
PROJECTED ACCRUAL: A total of 200 patients (120 for arm I and 80 for arm II) will be accrued for this study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I
Patients undergo unilateral cavernous nerve-sparing radical prostatectomy with unilateral autologous interposition sural nerve grafting.
Alprostadil (E1)
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Papaverine
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Phentolamine mesylate
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Sildenafil citrate
Oral sildenafil as needed
conventional surgery
Unilateral cavernous nerve sparing radical retropubic prostatectomy
Arm II (No sural nerve grafting)
Patients undergo unilateral cavernous nerve-sparing radical prostatectomy (without sural nerve grafting) and erectile dysfunction rehabilitation as in arm I.
Alprostadil (E1)
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Papaverine
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Phentolamine mesylate
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Sildenafil citrate
Oral sildenafil as needed
conventional surgery
Unilateral cavernous nerve sparing radical retropubic prostatectomy
Interventions
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Alprostadil (E1)
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Papaverine
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Phentolamine mesylate
Beginning 6 weeks after surgery, intracavernous Triplemix (prostaglandin E1, papaverine, and phentolamine) injected twice weekly
Sildenafil citrate
Oral sildenafil as needed
conventional surgery
Unilateral cavernous nerve sparing radical retropubic prostatectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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)
65 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Christopher G. Wood, MD
Role: STUDY_CHAIR
M.D. Anderson Cancer Center
Locations
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M.D. Anderson Cancer Center at University of Texas
Houston, Texas, United States
Countries
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References
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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 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.
Related Links
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UT MD Anderson Cancer Center Website
Other Identifiers
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MDA-ID-01304
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000355366
Identifier Type: REGISTRY
Identifier Source: secondary_id
ID01-304
Identifier Type: -
Identifier Source: org_study_id