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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00544076 |
RATIONALE: Sildenafil and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction.
PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.
Condition | Intervention |
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Cancer-Related Problem/Condition Prostate Cancer |
Drug: alprostadil Drug: sildenafil citrate Procedure: laparoscopic surgery Procedure: quality-of-life assessment Procedure: questionnaire administration |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized |
Official Title: | Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer |
Estimated Enrollment: | 204 |
Study Start Date: | November 2005 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive 2 doses of intraurethral alprostadil prior to undergoing bilateral nerve-sparing robotic-assisted prostatectomy (BNS-RAP). Within 2 weeks after surgery, patients are randomized to 1 of 3 treatment arms. In arms I and III, treatment begins at the first postoperative visit.
Patients undergo assessment of erectile dysfunction, penile length, rate of urinary incontinence, and sexual function quality of life at baseline (preoperatively) and periodically during study. Patients are also assessed using a self-reported diary that records daily maintenance therapy, nocturnal erections, pharmacotherapy for intercourse, and the results of pharmacotherapy usage (i.e., no erection, erection sufficient for penetration, or erection insufficient for intercourse).
After completion of study therapy, patient are followed periodically for up to 18 months.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of prostate cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
United States, California | |
City of Hope Comprehensive Cancer Center | Recruiting |
Duarte, California, United States, 91010-3000 | |
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org |
Principal Investigator: | Laura E. Crocitto, MD | Beckman Research Institute |
Study ID Numbers: | CDR0000570272, CHNMC-04071 |
Study First Received: | October 13, 2007 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00544076 |
Health Authority: | Unspecified |
sexual dysfunction and infertility stage I prostate cancer stage II prostate cancer |
Alprostadil Infertility Prostatic Diseases Genital Neoplasms, Male Citric Acid |
Sildenafil Urogenital Neoplasms Genital Diseases, Male Erectile Dysfunction Prostatic Neoplasms |
Vasodilator Agents Molecular Mechanisms of Pharmacological Action Hematologic Agents Fibrinolytic Agents Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions |
Neoplasms Fibrin Modulating Agents Neoplasms by Site Phosphodiesterase Inhibitors Therapeutic Uses Platelet Aggregation Inhibitors |