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The following is a summary of “Nutritional supplement with fermented soy in men with an elevated risk of prostate cancer and negative prostate biopsies: General and oncological results from the prospective PRAECAP trial,” published in the April 2024 issue of Urology by Eecken et al.

The primary objective of this study was to assess the impact of a dietary supplement containing fermented soy on various parameters, including prostate-specific antigen (PSA) levels, International Prostate Symptom Score (IPSS), changes in prostate volume, and prostate cancer (PCa) development over a 6-month period in men at heightened risk of prostate cancer with negative previous biopsies. Eligible patients were identified based on elevated risk criteria such as PSA levels > 3 ng/ml, suspicious lesions upon digital rectal examination (DRE), and/or transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) findings, coupled with prior negative prostate biopsies (at least 8 cores) within 12 months before enrollment. 

Statistical analysis encompassed non-parametric one-sided paired Wilcoxon rank sum tests, chi-square tests, and Fisher’s exact tests. Of the 94 patients included in the trial, a noteworthy PSA response was observed in 81% of cases. Additionally, 25.8% of patients experienced a reduction of at least 3 points in IPSS scores. Notably, the median prostate volume remained statistically unchanged after 6 months. Patients exhibiting PSA modulation necessitated fewer investigations and exhibited fewer positive biopsies, particularly with ISUP≥3 lesions. In conclusion, administering a fermented soy supplement elicited a significant decrease in PSA levels after 6 months, with observed effects on IPSS in a subset of patients. This suggests a potential utility for fermented soy supplements in refining patient selection for those genuinely at increased risk of occult prostate cancer.

Source: sciencedirect.com/science/article/pii/S0090429524003005