title: Phase II trial of isoflavone in prostate-specific antigen recurrent prostate cancer after previous local therapy.
abstract: BACKGROUND
  Data exist that demonstrate isoflavones' potent antiproliferative effects on prostate cancer cells. We evaluated the efficacy of isoflavone in patients with PSA recurrent prostate cancer after prior therapy. We postulated that isoflavone therapy would slow the rate of rise of serum PSA.
  
  
  METHODS
  Twenty patients with rising PSA after prior local therapy were enrolled in this open-labeled, Phase II, nonrandomized trial (Trial registration # NCT00596895). Patients were treated with soy milk containing 47 mg of isoflavonoid per 8 oz serving three times per day for 12 months. Serum PSA, testosterone, lipids, isoflavone levels (genistein, daidzein, and equol), and quality of life (QOL) were measured at various time points from 0 to 12 months. PSA outcome was evaluated.
  
  
  RESULTS
  Within the mixed regression model, it was estimated that PSA had increased 56% per year before study entry and only increased 20% per year for the 12-month study period (p = 0.05). Specifically, the slope of PSA after study entry was significantly lower than that before study entry in 6 patients and the slope of PSA after study entry was significantly higher than before study entry in 2 patients. For the remaining 12 patients, the change in slope was statistically insignificant. Nearly two thirds of the patients were noted to have significant levels of free equol in their serum while on therapy.
  
  
  CONCLUSIONS
  Dietary intervention with isoflavone supplementation may have biologic activity in men with biochemical recurrent prostate cancer as shown by a decline in the slope of PSA. This study may lend support to the literature that nutritional supplements have biologic activity in prostate cancer and therefore, further studies with these agents in randomized clinical trials should be encouraged.
authors.affiliation: Division of Urology, The University of Florida, Jacksonville, Florida 32209, USA. john.pendleton@jax.ufl.edu
authors.forename: John M
authors.initials: JM
authors.lastname: Pendleton
authors.forename: Winston W
authors.initials: WW
authors.lastname: Tan
authors.forename: Satoshi
authors.initials: S
authors.lastname: Anai
authors.forename: Myron
authors.initials: M
authors.lastname: Chang
authors.forename: Wei
authors.initials: W
authors.lastname: Hou
authors.forename: Kathleen T
authors.initials: KT
authors.lastname: Shiverick
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Rosser
mesh_terms: D000230:Adenocarcinoma / Q000097:blood / Q000188:drug therapy*; D000368:Aged; D019587:Dietary Supplements; D060754:Equol; D019833:Genistein / Q000008:administration & dosage; D006801:Humans; D007529:Isoflavones / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy*; D011110:Polymorphism, Genetic; D017430:Prostate-Specific Antigen / Q000097:blood*; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy*; D011788:Quality of Life; D011944:Receptors, Androgen / Q000235:genetics
chemical_list: C007610:4',7-dihydroxy-3,4-dihydroisoflavone; D007529:Isoflavones; D011944:Receptors, Androgen; D060754:Equol; C004742:daidzein; D019833:Genistein; D017430:Prostate-Specific Antigen