title: Safety of purified isoflavones in men with clinically localized prostate cancer.
abstract: Our purpose was to evaluate the safety of 80 mg of purified isoflavones administered to men with early stage prostate cancer. A total of 53 men with clinically localized prostate cancer, Gleason score of 6 or below, were supplemented with 80 mg purified isoflavones or placebo for 12 wk administered in 2 divided doses of 40 mg to provide a continuous dose of isoflavones. Compliance, changes in plasma isoflavones, and clinical toxicity were analyzed at baseline, 4, and 12 wk. A total of 50 subjects completed the 12-wk intervention. A continuous, divided-dose administration of 80 mg/day of purified isoflavones at amounts that exceeded normal American dietary intakes significantly increased (P < 0.001) plasma isoflavones in the isoflavone-treated group compared to placebo and produced no clinical toxicity. With the current evidence on the cancer preventive properties of isoflavones, these results are significant and offer promise for these phytochemicals to be developed as potent agents to prevent cancer progression.
authors.affiliation: Department of Interdisciplinary Oncology, H. Lee Moffitt Cancer Center & Research Institute, Tampa, FL 33612, USA. Nagi.Kumar@moffitt.org
authors.forename: Nagi B
authors.initials: NB
authors.lastname: Kumar
authors.forename: Jeffrey P
authors.initials: JP
authors.lastname: Krischer
authors.forename: Kathy
authors.initials: K
authors.lastname: Allen
authors.forename: Diane
authors.initials: D
authors.lastname: Riccardi
authors.forename: Karen
authors.initials: K
authors.lastname: Besterman-Dahan
authors.forename: Raoul
authors.initials: R
authors.lastname: Salup
authors.forename: Lovellen
authors.initials: L
authors.lastname: Kang
authors.forename: Ping
authors.initials: P
authors.lastname: Xu
authors.forename: Julio
authors.initials: J
authors.lastname: Pow-Sang
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000097:blood / Q000627:therapeutic use; D019587:Dietary Supplements; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004958:Estradiol / Q000097:blood; D006801:Humans; D007529:Isoflavones / Q000009:adverse effects* / Q000097:blood* / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D048789:Phytoestrogens / Q000378:metabolism; D011471:Prostatic Neoplasms / Q000188:drug therapy*; D012449:Safety; D013739:Testosterone / Q000097:blood; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D007529:Isoflavones; D048789:Phytoestrogens; D013739:Testosterone; D004958:Estradiol