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Study 31 of 2431 for search of: | received on or after 11/14/2008 |
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Sponsors and Collaborators: |
Bay State Clinical Trials, Inc. GlaxoSmithKline |
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Information provided by: | Bay State Clinical Trials, Inc. |
ClinicalTrials.gov Identifier: | NCT00805701 |
Avodart (dutasteride) reduces the male hormone (DHT) that leads to prostate growth and stimulates cancerous growth. Avodart is currently approved by the FDA to treat men with symptoms of an enlarged prostate. Avodart works by reducing DHT and prostate size; therefore, the drug may be useful in improving lower urinary tract symptoms (LUTS) such as frequency, urgency, weak stream, and urination difficulty (dysuria), among others, in men with prostate cancer. Avodart may be effective in men with prostate cancer who are being treated with hormonal therapy with one injection of Zolodex (goserelin) followed one month later with a trans-urethral incision of the prostate (TUIP), and three months after that, seed implantation (SI) of the prostate.
The purpose of this study is to test whether Avodart (dutasteride) is effective on LUTS and dysuria in men with localized prostate cancer being treated with single-dose goserelin, TUIP, and interval SI.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: avodart Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Randomized, Double-Blind, Placebo-Controlled Trial Assessing The Efficacy And Safety Of Dutasteride At Improving Lower Urinary Tract Symptoms In Men With Clinically Localized Prostate Cancer Being Treated With Single-Dose Goserelin, Trans-Urethral Incision Of Prostate, And Interval Brachytherapy |
Estimated Enrollment: | 40 |
Study Start Date: | January 2009 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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0.5mg Avodart: Active Comparator
.5mg avodart capsule orally once a day during 13 months
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Drug: avodart
0.5 avodart once daily for 13 weeks
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Placebo: Placebo Comparator
placebo capsule orally daily for 13 months
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Drug: Placebo
placebo
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Dutasteride is an inhibitor of the 5 alpha reductase type I and type II enzymes that convert testosterone to DHT, the male hormone that leads to benign prostate growth and drives malignant growth. Dutasteride has been shown to significantly decrease intraprostatic DHT in men with localized prostate cancer, and additionally cause apoptosis and regression of some prostate cancers [Andriole, 2004a; Andriole, 2004b]. Furthermore, reduction in tumor volume has also been demonstrated in human prostate tissue [Iczkowski, 2004]. Dutasteride is currently indicated to treat symptomatic BPH in men with enlarged prostates, but is also being studied to reduce the risk of prostate cancer in men at risk (elevated PSA and previous negative biopsy). Dutasteride is clinically useful at improving lower urinary tract symptoms (LUTS) in men with clinically-localized prostate cancer and voiding difficulty being treated with single-dose goserelin, TUIP, and interval SI. [Mitcheson, personal observation].
Ages Eligible for Study: | 35 Years to 90 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:A subject will be eligible for inclusion in this study only if all of the following criteria apply:
Exclusion Criteria:
Subject has ever been treated for prostate cancer with any of the following:
Current and/or previous use of the following medications:
Responsible Party: | Bay State Clinical Trials, Inc. ( Henry David Mitcheson, MD ) |
Study ID Numbers: | 047838 |
Study First Received: | December 5, 2008 |
Last Updated: | December 9, 2008 |
ClinicalTrials.gov Identifier: | NCT00805701 |
Health Authority: | United States: Food and Drug Administration |
prostate cancer avodart dutasteride mitcheson |
Dutasteride Prostatic Diseases Genital Neoplasms, Male Goserelin |
Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |