Case Study of Noni Extract in Men with Very Low-Risk or Low-Risk Prostate Cancer.

The optimal treatment strategy for patients with early prostate cancer (PCa) is unknown. We explored the feasibility of administering noni supplementation to modify gene expression of a relevant clinical signature in the prostate of men on active surveillance for PCa. A total of 6 participants with low-risk (n=5) to very low-risk (n=1) PCa who were candidates for active surveillance received 6200 mg/day of noni in capsule form for 1 year; median age was 65.5 years (range, 58-75 years). Participants were tested for serum prostate-specific antigen (PSA) levels every 3 months. At 12 months, they underwent a repeat transrectal ultrasound-guided prostate biopsy. These biopsy samples were queried for expressing 12 key genes and rates of apoptosis, angiogenesis, and proliferation. The primary outcome was the change in expression of the 12 genes that comprise the Oncotype DX prostate cancer test from baseline to 12 months of noni supplementation. Noni was well tolerated, with only 1 participant reporting side effects of grade 2 diarrhea, requiring a drug holiday of 7 days. Median serum PSA slightly increased from 7.1 ng/mL (4.4-9.7 ng/ mL) prior to therapy to 7.9 ng/mL (5.7-10.2 ng/mL) on therapy. Changes were observed in the expression levels of several genes, including FAM13C, KLK2 (associated with the androgen pathway), and GSTM2 (associated with cellular organization) at 12 months. Noni supplementation was associated with favorable clinical parameters, including stable serum PSA among most patients and no evidence of tumor on repeat biopsy, and correlated with modulation of numerous genes and proteins.