title: Lack of an effect of high dose isoflavones in men with prostate cancer undergoing androgen deprivation therapy.
abstract: OBJECTIVE
  The profound hypogonadism due to androgen deprivation therapy for prostate cancer results in complications such as sexual dysfunction, poor quality of life, vasomotor symptoms and altered cognition. Since estrogen is associated with cardiovascular risks, phytoestrogens are being increasingly evaluated as a potential treatment for these adverse effects. We evaluated the effects of high dose isoflavones, equivalent to that consumed by Asian populations, on the aforementioned consequences of androgen deprivation therapy.
  
  
  METHODS
  A total of 33 men undergoing androgen deprivation therapy for prostate cancer were enrolled in this randomized, double-blind, placebo controlled, 12-week pilot trial. Participants were randomly assigned to receive 20 gm soy protein containing 160 mg total isoflavones (17) vs taste matched placebo, that is 20 gm whole milk protein (16). The study was performed at a tertiary care center in the United States.
  
  
  RESULTS
  At baseline the groups were well matched in demographic parameters, sleep quality, cognition and overall quality of life. However, men in the isoflavone group had a higher baseline prevalence of hot flashes and poor intercourse satisfaction compared to those on placebo. At 12 weeks there were no significant differences between the 2 groups in any outcome measure.
  
  
  CONCLUSIONS
  This pilot study of high dose isoflavones in androgen deprived men showed no significant improvement in cognition, vasomotor symptoms or any other aspect of quality of life measures compared to placebo. Future studies should use variable doses of isoflavones for a longer period before ruling out beneficial isoflavone effects in this population.
authors.affiliation: Georgetown University, Washington, DC, USA.
authors.forename: Preetika
authors.initials: P
authors.lastname: Sharma
authors.forename: Amy
authors.initials: A
authors.lastname: Wisniewski
authors.forename: Milena
authors.initials: M
authors.lastname: Braga-Basaria
authors.forename: Xiaoqiang
authors.initials: X
authors.lastname: Xu
authors.forename: Mary
authors.initials: M
authors.lastname: Yep
authors.forename: Samuel
authors.initials: S
authors.lastname: Denmeade
authors.forename: Adrian S
authors.initials: AS
authors.lastname: Dobs
authors.forename: Theodore
authors.initials: T
authors.lastname: DeWeese
authors.forename: Michael
authors.initials: M
authors.lastname: Carducci
authors.forename: Shehzad
authors.initials: S
authors.lastname: Basaria
mesh_terms: D000368:Aged; D000726:Androgen Antagonists / Q000009:adverse effects*; D004311:Double-Blind Method; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage* / Q000627:therapeutic use; D008297:Male; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000188:drug therapy*
chemical_list: D000726:Androgen Antagonists; D007529:Isoflavones