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Rosiglitazone versus placebo for men with prostate carcinoma and a rising serum prostate-specific antigen level after radical prostatectomy and/or radiation therapy†
Article first published online: 13 AUG 2004
Copyright © 2004 American Cancer Society
Volume 101, Issue 7, pages 1569–1574, 1 October 2004
How to Cite
Smith, M. R., Manola, J., Kaufman, D. S., George, D., Oh, W. K., Mueller, E., Slovin, S., Spiegelman, B., Small, E. and Kantoff, P. W. (2004), Rosiglitazone versus placebo for men with prostate carcinoma and a rising serum prostate-specific antigen level after radical prostatectomy and/or radiation therapy. Cancer, 101: 1569–1574. doi: 10.1002/cncr.20493
Presented in part as Abstract 1588 at the 39th annual meeting of the American Society of Clinical Oncology, Chicago, Illinois, May 31–June 3, 2003.
- Issue published online: 17 SEP 2004
- Article first published online: 13 AUG 2004
- Manuscript Accepted: 10 JUN 2004
- Manuscript Revised: 8 JUN 2004
- Manuscript Received: 15 APR 2004
- National Institutes of Health. Grant Number: 5 P50 CA90381-02
- Prostate Cancer Foundation
- SmithKline Beecham Pharmaceuticals
- prostate carcinoma;
- prostate-specific antigen;
- peroxisome proliferator activated receptor γ;
The objective of this study was to assess the biologic activity of rosiglitazone, a peroxisome proliferator-activated receptor γ agonist that has been approved to treat type 2 diabetes, in men with recurrent prostate carcinoma using change in prostate specific antigen (PSA) doubling time (PSADT) as the primary outcome variable.
Men with histologically confirmed prostate carcinoma, no recent hormone therapy, a rising serum PSA level after radical prostatectomy and/or radiation therapy, and no radiographic evidence of metastases were assigned randomly to receive either oral rosiglitazone (4 mg twice daily) or placebo. The treatment was continued until the men developed disease progression or adverse effects. A positive outcome was defined as a posttreatment PSADT > 150% the baseline PSADT and no new metastases.
One hundred six men were enrolled. The median treatment duration was 315 days for men in the placebo group and 338 days for men in the rosiglitazone group (P = 0.28). Forty percent of men in the in the placebo group and 38% of men in the rosiglitazone group had a posttreatment PSADT > 150% of the baseline PSADT and no new metastases (P = 1.00). In exploratory analyses, the rate of a positive outcome remained higher than expected in the placebo group, even when a positive outcome was redefined using more stringent criteria. The time to disease progression was similar between the groups.
Rosiglitazone did not increase PSADT or prolong the time to disease progression more than placebo in men with a rising PSA level after radical prostatectomy and/or radiation therapy. The unexpected discordance between baseline and posttreatment PSADT in the placebo group reinforced the importance of randomized controlled trials in this setting. Cancer 2004. © 2004 American Cancer Society.