Oncotarget Phase II randomized clinical trial - aglycone isoflavones and prostate cancer


Oncotarget Volume 11 Issue 14 reported that 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.

A significant reduction in serum PSA was observed with isoflavone supplementation in CM compared to the placebo arm, but not observed in AAM. Well-powered studies for longer duration of intervention may inform future trials with isoflavones, for chemoprevention of PCa.

Dr. Nagi B. Kumar from the Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Inc., Tampa, FL, USA said, "Prostate cancer (PCa) is the most prevalent cancer in American men."

"Prostate cancer (PCa) is the most prevalent cancer in American men."

- Dr. Nagi B. Kumar, Cancer Epidemiology, H. Lee Moffitt Cancer Center and Research Institute, Inc.

In comparison with earlier retrospective and family-based studies, recent prospective studies have arrived at somewhat lower age-specific risk estimates for cancers occurring in MMR variant carriers; moreover, penetrance and expression patterns greatly depend on the MMR gene involved.

Among individual MMR genes, pathogenic variants in MLH1 and MSH2 have the highest and PMS2 the lowest penetrance, and MSH6 variants underlie a sex-limited trait with a high risk of gynecological cancers in females.

Moreover, breast cancer risk has been reported to be specifically associated with certain MMR genes, including MLH1, MSH2, and MSH6 and PMS2 and absent MMR protein expression by immunohistochemical analysis of tumor tissues are common pre-screening methods for LS.

Figure 1: Consort diagram.

Figure 1: Consort diagram. 1Previously undetected exclusionary medical factors included 3 patients with elevated kidney function results. 2Pathology review showed no presence of CaP. 33subjects withdrew consent and 2 off study due to AE (1 unlikely related and 1 probably related to study). 42 subjects withdrew consent; 1 off study due to AE (possibly related to study).

The Kumar Research Team concluded in their Oncotarget Research Article that, The study was in addition informed by population laboratory, animal studies and early phase trials demonstrating a rationale for further evaluating isoflavones for PCa chemoprevention.

Accrual of AAM in the study was far lower than expected, and our study was ultimately underpowered to detect small reductions in specific biomarkers of disease progression in men with localized PCa. The study, in addition, used a window of opportunity study design providing an opportunity to evaluate agents for safety and efficacy signals using intermediate endpoint biomarkers of prostate cancer progression.

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DOI - https://doi.org/10.18632/oncotarget.27529

Full text - https://www.oncotarget.com/article/27529/text/

Correspondence to - Nagi B. Kumar - [email protected]

Keywords - isoflavones, chemoprevention, prostate cancer, African American men, Caucasian men

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