Mp58-01 a Randomized Controlled Trial of a Fermented Soy Beverage Among Patients With Localized Prostate Cancer Prior to Radical Prostatectomy

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy III (MP58)1 May 2024MP58-01 A RANDOMIZED CONTROLLED TRIAL OF A FERMENTED SOY BEVERAGE AMONG PATIENTS WITH LOCALIZED PROSTATE CANCER PRIOR TO RADICAL PROSTATECTOMY Soum D. Lokeshwar, Ankur U. Choksi, Ather Ali, Theresa Weiss, Jesse Reynolds, Brian M. Shuch, Thomas Ferencz, Tassos C. Kyriakides, Joseph Brito, Joseph Renzulli, and Michael S. Leapman Soum D. LokeshwarSoum D. Lokeshwar , Ankur U. ChoksiAnkur U. Choksi , Ather AliAther Ali , Theresa WeissTheresa Weiss , Jesse ReynoldsJesse Reynolds , Brian M. ShuchBrian M. Shuch , Thomas FerenczThomas Ferencz , Tassos C. KyriakidesTassos C. Kyriakides , Joseph BritoJoseph Brito , Joseph RenzulliJoseph Renzulli , and Michael S. LeapmanMichael S. Leapman View All Author Informationhttps://doi.org/10.1097/01.JU.0001008852.83523.41.01AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Soy isoflavones have been reported to possess inhibitory effects on several cancers including prostate. We evaluated the clinical effect of a fermented soy beverage among men with localized prostate cancer prior to radical prostatectomy. METHODS: We conducted a placebo-controlled, double-blind randomized controlled trial of Q-Can®, a fermented soy beverage containing high concentrations of soy isoflavones. Stratified randomization (Cancer of the Prostate Risk Assessment (CAPRA) score at diagnosis) was used to assign patients to receive either Q-Can® or placebo for 2-5 weeks prior to prostatectomy. The primary endpoint was change in serum PSA level from baseline to end of study. We also assessed changes in other clinical and pathologic endpoints including prognostic Gleason Grade Group, stage, margin status, overall CAPRA score, lipid levels, testosterone, and health related quality of life (FACT-P score). The primary intention to treat (ITT) analysis compared PSA at end of study between randomization arms using a repeated measures linear mixed model incorporating baseline CAPRA risk strata. RESULTS: We randomized 19 patients, of whom 16 were eligible for analysis of the primary study outcome. The mean age at enrollment was 61 years, 9 (56.2%) were classified as low and intermediate risk, and 7 (43.8%) high CAPRA risk. Among patients who received QC, the mean PSA at baseline and end of study was 8.97 (standard error, SE 0.99) and 8.14 ng/mL (SE 1.01) compared with 8.83 (SE 1.05) to 9.14 ng/mL (SE 1.10), respectively, p=0.76. There were no significant differences in Gleason score, clinical stage, surgical margin status, or CAPRA score between treatment arms (p>0.05 for all). In addition, there were no significant differences between treatment arms in end-of-study or change in lipids, free and total testosterone and FACT-P scores (p>0.05 for all). CONCLUSIONS: A short exposure to a fermented soy beverage among patients with localized prostate cancer was not associated with changes in PSA levels, prostate cancer characteristics including grade and stage or serum testosterone. As a consequence of early termination, study power, per design, was not achieved. Source of Funding: BESO Biologic Research Inc © 2024 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 211Issue 5SMay 2024Page: e947 Advertisement Copyright & Permissions© 2024 by American Urological Association Education and Research, Inc.Metrics Author Information Soum D. Lokeshwar More articles by this author Ankur U. Choksi More articles by this author Ather Ali More articles by this author Theresa Weiss More articles by this author Jesse Reynolds More articles by this author Brian M. Shuch More articles by this author Thomas Ferencz More articles by this author Tassos C. Kyriakides More articles by this author Joseph Brito More articles by this author Joseph Renzulli More articles by this author Michael S. Leapman More articles by this author Expand All Advertisement PDF downloadLoading ...