The study chair for this trial is Nagi Kumar, PhD, RD, FADA (Moffitt Cancer Center). The study co-chairs are Raymond Bergan, MD (University of Nebraska/Fred & Pamela Buffett Cancer Center) and Julio Pow-Sang, MD (Moffitt Cancer Center).
Men on active surveillance (AS) for early-stage, low grade prostate cancer (PCa) tend to be highly motivated to make lifestyle changes to reduce the risk of their cancer progressing, providing an ideal target for secondary chemoprevention. The effects and safety of one such promising chemopreventive agent—using compounds found in green tea extract (green tea catechins [GTC])—are being investigated in the recently activated study, EA8184.
In Asian countries, where tea is extensively consumed as a beverage, the death rates from prostate cancer are among the lowest in the world. This and other observations led to preclinical and early-phase study of GTCs, administered orally, in small groups of men with early prostate cancer. So far, research has demonstrated GTC to be associated with reduced tumor size and a decrease in prostate-specific antigen (PSA) levels in this group of patients, with an acceptable safety profile.
For this phase II study, men on AS for PCa with a biopsy-confirmed Gleason Score (3+3 or 3+4) and Ki-67 protein expression (5% or greater) will be randomized 1:1 to either the study drug—a standardized oral GTC formulation—or placebo for 6 months. It is expected that 720 patients with low or favorable intermediate risk PCa per NCCN guidelines will be screened in Step 0 to reach the Step 1 accrual goal of 360 patients for randomization.
The study’s primary endpoint is disease progression as measured by the % change in the expression of Ki-67, based on the comparison of tissue from initial (screening) and end-of-study biopsies. Safety will be measured by common terminology for adverse events (CTCAE), blood count, metabolic panel, and liver function toxicities. Patient reported outcomes will examine lower urinary tract symptoms and quality-of-life scores using FACT-Prostate assessments and will be assessed at baseline and at 3 and 6 months.
If positive, results obtained from this study will inform planning and implementation of a prospective national randomized phase III clinical trial using GTC pills for preventing progression of PCa in men on AS.
The National Cancer Institute is funding study EA8184 through its NCI Community Oncology Research Program (NCORP).
Learn more about EA8184 at ecog-acrin.org.