Home
Search
Study Topics
Glossary
|
|
|
|
|
|
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 |
---|---|---|
Cancer-Related Problem/Condition Prostate Cancer |
Drug: alprostadil Drug: papaverine Drug: phentolamine mesylate Drug: sildenafil citrate Procedure: conventional surgery |
Phase II |
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 |
Study Chair: | Christopher G. Wood, MD | M.D. Anderson Cancer Center |
Study ID Numbers: | CDR0000355366, MDA-ID-01304 |
Study First Received: | April 7, 2004 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00080808 |
Health Authority: | United States: Federal Government |
perioperative/postoperative complications sexual dysfunction and infertility sexuality and reproductive issues |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
Alprostadil Sexual Dysfunctions, Psychological Infertility Papaverine Genital Neoplasms, Male Prostatic Diseases Citric Acid Urogenital Neoplasms Sildenafil |
Genital Diseases, Male Phentolamine Sexual Dysfunction, Physiological Postoperative Complications Mental Disorders Adenocarcinoma Prostatic Neoplasms Erectile Dysfunction |
Neurotransmitter Agents Vasodilator Agents Adrenergic Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Enzyme Inhibitors Fibrinolytic Agents Adrenergic alpha-Antagonists Cardiovascular Agents |
Antihypertensive Agents Sexual and Gender Disorders Pharmacologic Actions Neoplasms Fibrin Modulating Agents Neoplasms by Site Phosphodiesterase Inhibitors Therapeutic Uses Adrenergic Antagonists Platelet Aggregation Inhibitors |