Study of Metformin With Simvastatin for Men With Prostate Carcinoma

Summary

The purpose of this study is to find out whether the two drugs used in the study, metformin and simvastatin, can slow down the speed of rise of prostate specific antigen (PSA) or stop its rise or even bring the level down. Recently, scientists noticed that men who take metformin to treat their high blood sugar or simvastatin to treat their high cholesterol are less likely to develop prostate cancer. Also, scientists found that, when these drugs are used in preclinical studies, they can slow down the growth of the prostate cancer cells. This study will try to find out whether these drugs can actually slow down the growth of prostate cancer in men.

Timeline

Start

2012-01

Primary completion

2014-07

Completion

2014-07

Publications

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• Background Hankinson SE, Willett WC, Colditz GA, Hunter DJ, Michaud DS, Deroo B, Rosner B, Speizer FE, Pollak M. Circulating concentrations of insulin-like growth factor-I and risk of breast cancer. Lancet. 1998 May 9;351(9113):1393-6. doi: 10.1016/S0140-6736(97)10384-1.
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• Background Arita Y, Kihara S, Ouchi N, Takahashi M, Maeda K, Miyagawa J, Hotta K, Shimomura I, Nakamura T, Miyaoka K, Kuriyama H, Nishida M, Yamashita S, Okubo K, Matsubara K, Muraguchi M, Ohmoto Y, Funahashi T, Matsuzawa Y. Paradoxical decrease of an adipose-specific protein, adiponectin, in obesity. Biochem Biophys Res Commun. 1999 Apr 2;257(1):79-83. doi: 10.1006/bbrc.1999.0255.
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• Background Ma J, Pollak MN, Giovannucci E, Chan JM, Tao Y, Hennekens CH, Stampfer MJ. Prospective study of colorectal cancer risk in men and plasma levels of insulin-like growth factor (IGF)-I and IGF-binding protein-3. J Natl Cancer Inst. 1999 Apr 7;91(7):620-5. doi: 10.1093/jnci/91.7.620.
• Background Giovannucci E, Pollak MN, Platz EA, Willett WC, Stampfer MJ, Majeed N, Colditz GA, Speizer FE, Hankinson SE. A prospective study of plasma insulin-like growth factor-1 and binding protein-3 and risk of colorectal neoplasia in women. Cancer Epidemiol Biomarkers Prev. 2000 Apr;9(4):345-9.
• Background Harman SM, Metter EJ, Blackman MR, Landis PK, Carter HB; Baltimore Longitudinal Study on Aging. Serum levels of insulin-like growth factor I (IGF-I), IGF-II, IGF-binding protein-3, and prostate-specific antigen as predictors of clinical prostate cancer. J Clin Endocrinol Metab. 2000 Nov;85(11):4258-65. doi: 10.1210/jcem.85.11.6990.
• Background Stattin P, Bylund A, Rinaldi S, Biessy C, Dechaud H, Stenman UH, Egevad L, Riboli E, Hallmans G, Kaaks R. Plasma insulin-like growth factor-I, insulin-like growth factor-binding proteins, and prostate cancer risk: a prospective study. J Natl Cancer Inst. 2000 Dec 6;92(23):1910-7. doi: 10.1093/jnci/92.23.1910.
• Background Amling CL, Kane CJ, Riffenburgh RH, Ward JF, Roberts JL, Lance RS, Friedrichs PA, Moul JW. Relationship between obesity and race in predicting adverse pathologic variables in patients undergoing radical prostatectomy. Urology. 2001 Nov;58(5):723-8. doi: 10.1016/s0090-4295(01)01373-5.
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• Background Chang S, Hursting SD, Contois JH, Strom SS, Yamamura Y, Babaian RJ, Troncoso P, Scardino PS, Wheeler TM, Amos CI, Spitz MR. Leptin and prostate cancer. Prostate. 2001 Jan 1;46(1):62-7. doi: 10.1002/1097-0045(200101)46:13.0.co;2-v.
• Background Hsing AW, Chua S Jr, Gao YT, Gentzschein E, Chang L, Deng J, Stanczyk FZ. Prostate cancer risk and serum levels of insulin and leptin: a population-based study. J Natl Cancer Inst. 2001 May 16;93(10):783-9. doi: 10.1093/jnci/93.10.783.
• Background Rodriguez C, Patel AV, Calle EE, Jacobs EJ, Chao A, Thun MJ. Body mass index, height, and prostate cancer mortality in two large cohorts of adult men in the United States. Cancer Epidemiol Biomarkers Prev. 2001 Apr;10(4):345-53.
• Background Stattin P, Soderberg S, Hallmans G, Bylund A, Kaaks R, Stenman UH, Bergh A, Olsson T. Leptin is associated with increased prostate cancer risk: a nested case-referent study. J Clin Endocrinol Metab. 2001 Mar;86(3):1341-5. doi: 10.1210/jcem.86.3.7328.
• Background Zhou G, Myers R, Li Y, Chen Y, Shen X, Fenyk-Melody J, Wu M, Ventre J, Doebber T, Fujii N, Musi N, Hirshman MF, Goodyear LJ, Moller DE. Role of AMP-activated protein kinase in mechanism of metformin action. J Clin Invest. 2001 Oct;108(8):1167-74. doi: 10.1172/JCI13505.

Drugs

Indications