Background/Objectives: To investigate the effect of a fermented soy supplement during 18 months in patients under active surveillance (AS) for low-risk and selected favorable intermediate-risk prostate cancer (PCa), with an emphasis on PSA modulation. Methods: Low-risk patients with ISUP grade 1, clinical stage cT1 or cT2a, PSA < 10 ng/mL and favorable intermediate-risk patients with ISUP grade 2 (<10% pattern 4), clinical stage T2b-c, PSA 10-20 ng/mL. The primary outcome was PSA response defined as maximum PSA rise less than or equal to 0.87 ng/mL after 1 year, based on the weighted average of PSA velocity (PSAV) in previous studies in similar populations. Secondary outcomes were disease progression, adverse histology on repeat biopsy or switch to active therapy. In addition, primary and secondary outcomes with imputed data were also determined as sensitivity analyses, using Mann-Whitney U or Chi-squared tests. Results: Overall, 92 (61.3%) of 150 patients showed a PSA level response. This was more evident in ISUP 1 patients and resulted in fewer follow-up MRIs and fewer control biopsies, as well as a fewer number of positive control biopsies with statistical significance in the imputed dataset. Obtaining a PSA response was numerically associated with less initiated therapy. Conclusions: a fermented soy supplement in patients under AS for low-risk and selected favorable intermediate-risk PCa could be useful in selecting patients who may remain under AS or who may need to switch to active therapy.
Cancers. 2024 Oct 28*** epublish ***
Hans Van der Eecken, Diederik De Cock, Eduard Roussel, Alexander Giesen, Bram Vansevenant, Lieven Goeman, Thierry Quackels, Steven Joniau
Department of Urology, University Hospital Brussels, 1090 Brussels, Belgium., Biostatistics and Medical Informatics Research Group, Department of Public Health, Faculty of Medicine and Pharmacy, Vrije Universiteit Brussel (VUB), 1050 Brussels, Belgium., Department of Urology, University Hospitals Leuven, 3000 Leuven, Belgium., Department of Urology, AZ Delta Roeselare, 8800 Roeselare, Belgium., Department of Urology, Erasmus University Hospital Brussels, 1070 Brussels, Belgium.