Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
NCT ID: NCT00182052
Last Updated: 2013-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
100 participants
INTERVENTIONAL
2000-09-30
2003-08-31
Brief Summary
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Detailed Description
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* Before treatment begins the following tests will be performed: physical exam; bone scan; blood work (including PSA level test) and a urine sample.
* While on this study the following tests and procedures will be done once a month: review of side effects and routine blood tests (including PSA levels).
* While on this study the following tests and procedures will be done on months 2 and 4: review of side effects; routine blood tests (including PSA levels) and urine tests.
* If the patient's disease progressed the treatment code will be broken and if the patient was on placebo, they will have the option to begin taking rosiglitazone.
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Group 1
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.
Group 2
Placebo
Given orally twice daily.
Interventions
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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.
Placebo
Given orally twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Biochemical disease progression following local therapy defined as three rises in PSA with each PSA determination at least 4 weeks apart and each PSA value \> or = 0.2ng/ml
* For men treated with radical prostatectomy, PSA \> or = 2 ng/ml
* For men treated with primary radiation therapy or post-prostatectomy radiation therapy, PSA \> or = 2 ng/ml and \> 150% post-radiation nadir
* Not an appropriate candidate for salvage radiation therapy or salvage prostatectomy
* Baseline PSADT \< 24 months
* CALGB performance status of 0,1 or 2
Exclusion Criteria
* Prior hormonal therapy for recurrent prostate cancer
* Prior chemotherapy for prostate cancer
* Current treatment with insulin or an oral hypoglycemic
* History of treatment with thiazolidinediones
* Radiation therapy within 6 months
* SGOT \> 1.5 x ULN
* Fasting blood glucose \< 60 mg/dl
* NYHA Class 3 or 4 cardiac status
18 Years
MALE
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Massachusetts General Hospital
OTHER
Responsible Party
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Matthew R. Smith, MD, PhD
Professor of Medicine
Principal Investigators
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Matthew Smith, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Countries
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References
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Smith MR, Manola J, Kaufman DS, George D, Oh WK, Mueller E, Slovin S, Spiegelman B, Small E, Kantoff PW. Rosiglitazone versus placebo for men with prostate carcinoma and a rising serum prostate-specific antigen level after radical prostatectomy and/or radiation therapy. Cancer. 2004 Oct 1;101(7):1569-74. doi: 10.1002/cncr.20493.
Other Identifiers
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00-100
Identifier Type: -
Identifier Source: org_study_id
NCT00139412
Identifier Type: -
Identifier Source: nct_alias
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