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Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia.
Nutr Cancer. 2004; 48(2):160-70.NC

Abstract

A phase I clinical trial was conducted to determine the safety, pharmacokinetic parameters, and efficacy of orally administered isoflavones (genistein and daidzein, potential cancer chemotherapeutic agents) over a 3-mo period in men with prostate neoplasia. Twenty men, ages 40 and above, with stage B, C, or D adenocarcinoma of the prostate were treated with a multiple-dose regimen of a soy isoflavone formulation (delivering approximately 300 or 600 mg/day genistein and half this much daidzein) for 84 days. The delivered dose of isoflavones was more than 10-fold higher than that typically taken by prostate cancer patients. In men with prostate cancer, relatively minor side effects of chronic isoflavone treatment were observed including some estrogenic effects (breast changes, increased frequency of hot flashes). Serum dehydroepiandrosterone was decreased by 31.7% (P = 0.0004) at the end of treatment. Except for those subjects whose prostate-specific antigen (PSA) values were below 0.4 ng/ml, subjects had a history of increasing PSA levels prior to the trial. This increase continued during the trial both while on soy isoflavones and after treatment was discontinued. On average the rate of rise accelerated after soy isoflavones were discontinued, but that difference did not attain statistical significance. Genistein and daidzein were rapidly cleared from plasma and excreted in urine. Pharmacokinetic data for chronic dose administration were similar to single-dose administration for the isoflavones investigated except that we observed slightly longer circulation time for daidzein.

Authors+Show Affiliations

Department of Nutrition, School of Public Health, University of North Carolina, Chapel Hill, NC 27599-7461, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Clinical Trial, Phase I
Journal Article
Research Support, U.S. Gov't, P.H.S.

Language

eng

PubMed ID

15231450

Citation

Fischer, Leslie, et al. "Clinical Characteristics and Pharmacokinetics of Purified Soy Isoflavones: Multiple-dose Administration to Men With Prostate Neoplasia." Nutrition and Cancer, vol. 48, no. 2, 2004, pp. 160-70.
Fischer L, Mahoney C, Jeffcoat AR, et al. Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia. Nutr Cancer. 2004;48(2):160-70.
Fischer, L., Mahoney, C., Jeffcoat, A. R., Koch, M. A., Thomas, B. E., Valentine, J. L., Stinchcombe, T., Boan, J., Crowell, J. A., & Zeisel, S. H. (2004). Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia. Nutrition and Cancer, 48(2), 160-70.
Fischer L, et al. Clinical Characteristics and Pharmacokinetics of Purified Soy Isoflavones: Multiple-dose Administration to Men With Prostate Neoplasia. Nutr Cancer. 2004;48(2):160-70. PubMed PMID: 15231450.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Clinical characteristics and pharmacokinetics of purified soy isoflavones: multiple-dose administration to men with prostate neoplasia. AU - Fischer,Leslie, AU - Mahoney,Chrysa, AU - Jeffcoat,A Robert, AU - Koch,Matthew A, AU - Thomas,Brian E, AU - Valentine,John L, AU - Stinchcombe,Thomas, AU - Boan,Jarol, AU - Crowell,James A, AU - Zeisel,Steven H, PY - 2004/7/3/pubmed PY - 2005/4/9/medline PY - 2004/7/3/entrez SP - 160 EP - 70 JF - Nutrition and cancer JO - Nutr Cancer VL - 48 IS - 2 N2 - A phase I clinical trial was conducted to determine the safety, pharmacokinetic parameters, and efficacy of orally administered isoflavones (genistein and daidzein, potential cancer chemotherapeutic agents) over a 3-mo period in men with prostate neoplasia. Twenty men, ages 40 and above, with stage B, C, or D adenocarcinoma of the prostate were treated with a multiple-dose regimen of a soy isoflavone formulation (delivering approximately 300 or 600 mg/day genistein and half this much daidzein) for 84 days. The delivered dose of isoflavones was more than 10-fold higher than that typically taken by prostate cancer patients. In men with prostate cancer, relatively minor side effects of chronic isoflavone treatment were observed including some estrogenic effects (breast changes, increased frequency of hot flashes). Serum dehydroepiandrosterone was decreased by 31.7% (P = 0.0004) at the end of treatment. Except for those subjects whose prostate-specific antigen (PSA) values were below 0.4 ng/ml, subjects had a history of increasing PSA levels prior to the trial. This increase continued during the trial both while on soy isoflavones and after treatment was discontinued. On average the rate of rise accelerated after soy isoflavones were discontinued, but that difference did not attain statistical significance. Genistein and daidzein were rapidly cleared from plasma and excreted in urine. Pharmacokinetic data for chronic dose administration were similar to single-dose administration for the isoflavones investigated except that we observed slightly longer circulation time for daidzein. SN - 0163-5581 UR - https://www.unboundmedicine.com/medline/citation/15231450/Clinical_characteristics_and_pharmacokinetics_of_purified_soy_isoflavones:_multiple_dose_administration_to_men_with_prostate_neoplasia_ L2 - http://www.tandfonline.com/doi/full/10.1207/s15327914nc4802_5 DB - PRIME DP - Unbound Medicine ER -