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

• Published in: Nutrition and cancer Vol. 63; no. 6; pp. 889 - 898
• Main Authors: Lazarevic, Bato, Boezelijn, Gro, Diep, Lien My, Kvernrod, Kristin, Ogren, Olov, Ramberg, Hakon, Moen, Anders, Wessel, Nicolai, Berg, R. Egil, Egge-Jacobsen, Wolfgang, Hammarstrom, Clara, Svindland, Aud, Kucuk, Omer, Saatcioglu, Fahri, Taskèn, Kristin A, Karlsen, Steinar J
• Format: Journal Article
• Language: English
• Published: Philadelphia, PA Taylor & Francis Group 01-08-2011; Franklin Institute Press; Taylor& Francis; Taylor & Francis Ltd
• Subjects: antigens; Antioxidants; Biological and medical sciences; Biomarkers; Biomarkers - blood; blood serum; cholesterol; Cholesterol, HDL - blood; Cholesterol, LDL - blood; Clinical trials; Diet; Double-Blind Method; Endpoint Determination; Feeding. Feeding behavior; Fundamental and applied biological sciences. Psychology; genistein; Genistein - blood; Genistein - therapeutic use; Glycine max - chemistry; Gynecology. Andrology. Obstetrics; Humans; Immunohistochemistry; Male; Male genital diseases; Medical sciences; Middle Aged; Nephrology. Urinary tract diseases; patients; Phytotherapy; Placebo effect; Plant Extracts - therapeutic use; Prostate cancer; Prostatectomy; prostatic neoplasms; Prostatic Neoplasms - drug therapy; Prostatic Neoplasms - surgery; sex hormones; Thyrotropin - blood; Tumors; Tumors of the urinary system; Urinary tract. Prostate gland; Vertebrates: anatomy and physiology, studies on body, several organs or systems; Short term; Human; Isoflavone; Urinary system disease; Prostate disease; Tyrosine kinase inhibitor; Toxicity; Genistein; Early stage; Malignant tumor; Isoflavone derivatives; Flavonoid; Polyphenol; Randomization; Cancerology; Treatment; Surgery; Phase II trial; Phenols; Double blind study; Prostatectomy; Male genital diseases; Prostate cancer; Cancer
• DOI: 10.1080/01635581.2011.582221
• EISSN: 1532-7914
• ISSN: 1532-7914; 0163-5581

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.