Study Number Brief Study Title Study Design and Study Period Study status Primary outcomes
Cancer Prevention Study NCT01174953 High risk prostate cancer prevention study. Study of molecular effects of finasteride plus dietary soy supplementation in patients at high risk for the development of prostate cancer and creation of large database with health information. Non-randomized open label interventional study (July 2010 - Sep 2012) Active, not recruiting Identify biomarkers to predict patient at risk for prostate cancer and benefit from preventive strategies
Single agent treatment study NCT01036321 Phase II clinical trial of purified isoflavones in prostate cancer: comparing safety, effectiveness and mechanism of action between African American and Caucasian men Randomized double blinded phase II interventional study (Dec 2009 - Jan 2015) Recruiting Assess efficacy of isoflavones (40mg/day) versus placebo and evaluate side effects from supplementation
Single agent treatment study NCT01126879 Genistein in treating patients with prostate cancer Randomized double blinded phase II interventional study (May 2010- May 2014) Recruiting. Estimated enrollment 36. Determine if genistein decreases the number of circulating prostate cells in the blood
Early treatment combination study NCT01325311 Study of cholecalciferol and daily genistein (G-2535) versus placebo in men with early stage prostate cancer Randomized double blinded phase II interventional study (May 2011- May 2013) Not yet Recruiting. Estimated enrollment 50. Measure prostatic tissue levels of calcitriol, other cholecalciferol metabolite levels and all cholecalciferol metabolite levels in the plasma.
Combination Study NCT00499408 Vitamin D and soy supplements in treating patients with recurrent prostate cancer Phase II interventional study. April 2007- April 2009 (Primary completion period) Recruiting Serum PSA response to Vitamin D and soy supplements.
Combination Study NCT00354432 Soy/isoflavones and venlafaxine in treating hot flashes in patients receiving hormone therapy for prostate cancer Phase III randomized double blinded placebo controlled interventional Study. Feb 2007 - Feb 2010. (Estimated primary completion date) Active, not recruiting Assess the effect of soy protein/isoflavones and venlafaxine on the hot flash symptom severity score in patients undergoing hormonal manipulation for treatment of prostate cancer.
Combination study NCT01009736 Effects of tomato-soy juice on biomarkers in patients with prostate cancer undergoing prostatectomy Open label phase I-II interventional study. Jan 2008 – Jan 2009. (Estimated primary completion date) Recruiting Incidence and severity of toxicity associated with tomato-soy juice
Prevention of Recurrence Study NCT00765479 Soy protein in preventing recurrent cancer in patients who have undergone surgery for stage II prostate cancer Randomized double blinded phase II-III interventional study. Dec 2006 - Sep 2011. (Estimated primary completion date) Recruiting. Estimated enrollment 284. Two-year PSA failure rate (as a surrogate for recurrence) and time to PSA failure
Table 1: Retrieved from, Aug 26, 2011.