title: Efficacy and safety of short-term genistein intervention in patients with localized prostate cancer prior to radical prostatectomy: a randomized, placebo-controlled, double-blind Phase 2 clinical trial.
abstract: We conducted a placebo-controlled, block-randomized double-blind Phase 2 study to examine the effect of 30 mg synthetic genistein daily on serum and tissue biomarkers in patients with localized prostate cancer (CaP). Fifty-four study subjects were recruited and randomized to treatment with genistein (n = 23) or placebo (n = 24) for 3 to 6 wk prior to prostatectomy. Seven study subjects were noncompliant to the study protocol. Adverse events were few and mild. Serum prostate specific antigen (PSA) decreased by 7.8% in the genistein arm and increased by 4.4% in the placebo arm (P = 0.051). The PSA level was reduced in tumor tissue compared to normal tissue in the placebo arm. In the genistein arm, the PSA level in tumor and normal tissue was comparable. Total cholesterol was significantly lower in the genistein arm (P = 0.013). There were no significant effects on thyroid or sex hormones. Plasma concentrations of total genistein were on average 100-fold higher in the genistein arm after treatment (P < 0.001). Genistein at a dose that can be easily obtained from a diet rich in soy reduced the level of serum PSA in patients with localized CaP, without any effects on hormones. It was well tolerated and had a beneficial effect on blood cholesterol.
authors.affiliation: Department of Urology, Oslo University Hospital, Oslo, Norway. bato.lazarevic@medisin.uio.no
authors.forename: Bato
authors.initials: B
authors.lastname: Lazarevic
authors.forename: Gro
authors.initials: G
authors.lastname: Boezelijn
authors.forename: Lien My
authors.initials: LM
authors.lastname: Diep
authors.forename: Kristin
authors.initials: K
authors.lastname: Kvernrod
authors.forename: Olov
authors.initials: O
authors.lastname: Ogren
authors.forename: Hakon
authors.initials: H
authors.lastname: Ramberg
authors.forename: Anders
authors.initials: A
authors.lastname: Moen
authors.forename: Nicolai
authors.initials: N
authors.lastname: Wessel
authors.forename: R Egil
authors.initials: RE
authors.lastname: Berg
authors.forename: Wolfgang
authors.initials: W
authors.lastname: Egge-Jacobsen
authors.forename: Clara
authors.initials: C
authors.lastname: Hammarstrom
authors.forename: Aud
authors.initials: A
authors.lastname: Svindland
authors.forename: Omer
authors.initials: O
authors.lastname: Kucuk
authors.forename: Fahri
authors.initials: F
authors.lastname: Saatcioglu
authors.forename: Kristin A
authors.initials: KA
authors.lastname: Taskèn
authors.forename: Steinar J
authors.initials: SJ
authors.lastname: Karlsen
mesh_terms: D015415:Biomarkers / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D008078:Cholesterol, LDL / Q000097:blood; D004032:Diet; D004311:Double-Blind Method; D023381:Endpoint Determination; D019833:Genistein / Q000097:blood / Q000627:therapeutic use*; D006801:Humans; D007150:Immunohistochemistry; D008297:Male; D008875:Middle Aged; D008517:Phytotherapy; D010936:Plant Extracts / Q000627:therapeutic use*; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D013025:Glycine max / Q000737:chemistry; D013972:Thyrotropin / Q000097:blood
chemical_list: D015415:Biomarkers; D008076:Cholesterol, HDL; D008078:Cholesterol, LDL; D010936:Plant Extracts; D013972:Thyrotropin; D019833:Genistein