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Sponsors and Collaborators: |
M.D. Anderson Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00080808 |
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.
Condition | Intervention | Phase |
Perioperative/Postoperative Complications Prostate Cancer Sexual Dysfunction and Infertility Sexuality and Reproductive Issues |
Drug: alprostadil Drug: papaverine Drug: phentolamine mesylate Drug: sildenafil citrate Procedure: conventional surgery |
Phase II |
MedlinePlus related topics: | Cancer Erectile Dysfunction Infertility Prostate Cancer |
ChemIDplus related topics: | Sildenafil citrate Sildenafil Citric acid Sodium Citrate Phentolamine Alprostadil Papaverine Phentolamine mesylate |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Open Label, Active Control |
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 |
Estimated Enrollment: | 200 |
Study Start Date: | August 2001 |
OBJECTIVES:
OUTLINE: This is a randomized, open-label study. Patients are randomized to 1 of 2 treatment arms.
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.
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.
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of clinically localized adenocarcinoma of the prostate
Candidate for unilateral nerve-sparing radical retropubic prostatectomy
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Texas | |||||
M.D. Anderson Cancer Center at University of Texas | |||||
Houston, Texas, United States, 77030-4009 |
M.D. Anderson Cancer Center |
National Cancer Institute (NCI) |
Study Chair: | Christopher G. Wood, MD | M.D. Anderson Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000355366, MDA-ID-01304 |
First Received: | April 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00080808 |
Health Authority: | United States: Federal Government |
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