A phase II randomized clinical trial using aglycone isoflavones to treat patients with localized prostate cancer in the pre-surgical period prior to radical prostatectomy

// Nagi B. Kumar 1 , Julio Pow-Sang 2 , Philippe Spiess 2 , Shohreh Dickinson 3 and Michael J. Schell 4 1 Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL, USA 2 Department of Urology, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL, USA 3 Department of Pathology, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL, USA 4 Department of Biostatistics, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL, USA Correspondence to: Nagi B. Kumar, email: nagi.kumar@moffitt.org Keywords: isoflavones; chemoprevention; prostate cancer; African American men; Caucasian men Received: September 24, 2019     Accepted: March 03, 2020     Published: April 07, 2020 ABSTRACT Prostate cancer (PCa) is the most common cancer in American men. Additionally, African American Men (AAM) are 60% more likely to be diagnosed with PCa and 2.4 times more likely to die from this disease compared to Caucasian men (CM). To date, there are few strategies effective for chemoprevention for men with localized PCa. There is thus a need to continue to evaluate agents and strategies for chemoprevention of prostate cancer. Epidemiological, laboratory and early phase clinical trials have shown that the isoflavones modulates several biomarkers implicated in prostate carcinogenesis. The goal of this phase II randomized clinical trial was to explore the comparative effectiveness and safety of 40 mgs of aglycone isoflavones in AAM and CM with localized PCa in the pre-surgical period prior to radical prostatectomy. Thirty six participants (25 CM, 6AAM) were randomized to the isoflavone arm and 34 (25 CM, 7AAM) to the placebo arm, with 62 completing the intervention. Results indicated that isoflavones at a dose of 20 mgs BID for 3-6 weeks was well tolerated but did not reduce tissue markers of proliferation. A significant reduction in serum PSA was observed with isoflavone supplementation in CM compared to the placebo arm, but not observed in AAM. We observed no changes in serum steroid hormones with isoflavone supplementation. In AAM, a reduction in serum IGF-1 concentrations and IGF1: IGFBP-3 ratios were observed with isoflavone supplementation. Well-powered studies for longer duration of intervention may inform future trials with isoflavones, for chemoprevention of PCa.