Effects of Muscadine Grape Extract in Men With Prostate Cancer on Androgen Deprivation Therapy

Summary

It is estimated that one-third of the more than 7 million deaths from cancer worldwide are attributable to potentially modifiable risk factors, with 374,000 deaths preventable through diet modification alone. Diet supplementation for the prevention or treatment of cancer is attractive, as implementation is relatively easy, even in populations with reduced incomes and resources. Grape extracts or active components isolated from grapes have received attention as chemopreventive or therapeutic agents based upon their anti-proliferative, anti-inflammatory, and anti-oxidant properties. Evidence from preclinical trials also suggests that muscadine grape products may decrease systemic inflammation. This study builds upon promising preclinical and clinical evidence to determine if the addition muscadine grape extract (MGE) to androgen deprivation therapy (ADT) improves symptoms in men with prostate cancer.

Timeline

Start

2019-01-29

Primary completion

2025-02-20

Completion

2025-08-14

Outcome

Missed primary endpoint

registry analysis (superiority test); MGE Group vs Placebo Group; p = 0.454; ANCOVA NCT03496805 ↗

Drugs

Indications