Clinical trial · Interventional
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer
Rosiglitazone (Avandia) vs. Placebo for Androgen Dependent Prostate Cancer: A Randomized Double-Blind, Placebo Controlled Phase III Study
NCT00182052CI-TRIAL-00010392completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Rosiglitazone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group 1
- interventionNames
- Drug: Rosiglitazone
- type
- PLACEBO_COMPARATOR
- label
- Group 2
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- To evaluate the activity of rosiglitazone by comparing changes in PSA doubling time between rosiglitazone-treated and placebo-treated men.
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- Evaluate time to PSA progression as a measure of the activity of rosiglitazone.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed adenocarcinoma of the prostate * 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: * Metastatic disease * 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
References
Publications (1)
- BACKGROUNDSmith 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. PMID 15468186