Randomized, Double-blind, Placebo-controlled, Pilot Study of Add-on Beta Sitosterol Supplementation on Treatment Response in Prostate Cancer Patients

Prostate cancer is the second most frequent cancer diagnosis made in men and fourth most common cancer overall. There is a need to explore for safer and more efficient prostate cancer treatment. Standard systemic therapy(Androgen Deprivation therapy +/- Abiraterone Acetate )  for prostate cancer only improves 3 year overall survival by 76-83%. In addition, it is possible for upto 47% of these patients to experience serious adverse effects. Beta Sitosterol is a safe supplement which has demonstrated promising  anticancer activity against prostate and other types of cancers in preclinical in vitro and in vivo studies. More clinical research is needed to demonstrate the anticancer effect of beta sitosterol in real life prostate cancer patients.  This study aims to find out the effect of Beta Sitosterol as add on therapy with ongoing standard of care (SOC) on treatment response in persons with prostate cancer. After enrolment in this study, a detailed history about patient’s prostate cancer, its on-going treatment and various lab investigations will be obtained. Each patient will get an equal chance to be enrolled into either of the two groups where one group will receive Beta Sitosterol supplementation and another will receive a placebo for 3 months of duration along with on-going SOC treatment. There will be no change in the SOC treatment regimen during the intervention period. Patients will be followed-up for 3 months period. Primary outcome will be assessed in terms of change in PSA (Prostate specific antigen) levels at 3 months.