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Sponsors and Collaborators: |
Massachusetts General Hospital Dana-Farber Cancer Institute |
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Information provided by: | Massachusetts General Hospital |
ClinicalTrials.gov Identifier: | NCT00182052 |
The purpose of this study it to learn the effects (good or bad) that rosiglitazone has on patients and their prostate cancer. This study is going to look at what effects rosiglitazone has on prostate specific antigen (PSA) levels.
Condition | Intervention | Phase |
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Adenocarcinoma of the Prostate Prostate Cancer |
Drug: Rosiglitazone Other: Placebo |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study |
Enrollment: | 100 |
Study Start Date: | September 2000 |
Primary Completion Date: | August 2003 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator |
Drug: Rosiglitazone
Given orally twice daily. Participants may continue study treatment as long as their disease does not progress and they don't experience any serious side effects.
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Group 2: Placebo Comparator |
Other: Placebo
Given orally twice daily.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Matthew Smith, MD | Massachusetts General Hospital |
Responsible Party: | Massachusetts General Hospital ( Matthew Smith, MD, PhD ) |
Study ID Numbers: | 00-100 |
Study First Received: | September 14, 2005 |
Last Updated: | December 28, 2007 |
ClinicalTrials.gov Identifier: | NCT00182052 History of Changes |
Health Authority: | United States: Food and Drug Administration |
rosiglitazone Avandia androgen dependant prostate cancer |
Genital Neoplasms, Male Prostatic Diseases Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male Hormones |
Carcinoma Hypoglycemic Agents Adenocarcinoma Prostatic Neoplasms Rosiglitazone Neoplasms, Glandular and Epithelial Androgens |
Neoplasms by Histologic Type Genital Neoplasms, Male Prostatic Diseases Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Urogenital Neoplasms Genital Diseases, Male Hormones Pharmacologic Actions |
Carcinoma Neoplasms Hypoglycemic Agents Neoplasms by Site Adenocarcinoma Prostatic Neoplasms Rosiglitazone Neoplasms, Glandular and Epithelial Androgens |