Prostate Cancer Clinical Trial
Official title:
Phase II Clinical Study of Noni Extract in Men With Very Low Risk or Low Risk Prostate Cancer
The purpose of this study is to evaluate the effects of Noni extract in men diagnosed with very low risk or low risk prostate cancer
Efficacy and safety of Noni extract will be assessed in an estimated sample size of 30 subjects. Efficacy will be measured by the induction of favorable gene expression changes on Oncotype Dx Prostate Cancer Test after 12 months of intervention with Noni extract (6,000 mg/day). Other efficacy endpoints include the incidence of tumor progression after 12 months of intervention with Noni extract and serum PSA doubling time. Safety measurements will include the incidence and severity of adverse events, effects on angiogenesis (CD34), cell proliferation (Ki-67), and apoptosis (TUNEL) in prostate tissue biopsy samples from Month 12 ;
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