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Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)
This randomized double-blinded Phase II clinical trial will evaluate the bioavailability, safety, effectiveness and validate the mechanism by which a standardized formulation of whole Green Tea Catechin, (Sunphenon® 90D) containing 400 mgs (BID) vs. Placebo, administered for 24 months in a cohort of men with low to intermediate grade prostate cancer managed on active surveillance
Primary Outcome Measure: To assess the rate of clinical progression in men on active surveillance for prostate cancer (Gleason score (GS) 3+3 OR predominant Gleason grade 3 ( 3+4), ≤ 33% of biopsy cores positive for cancer and ≤ 50% involvement of any one core), treated with standardized GTC (400 mg EGCG bid) vs. placebo for 24 months, with rate of clinical progression defined as a composite outcome on repeat prostate biopsy >33% of biopsy cores positive for cancer or > 50% of any biopsy tissue core positive for cancer or adverse reclassification of Gleason sum > 3+3 or >3+4 respectively at end of study (EOS) biopsy. Secondary outcome measures: In patients randomized to receive GTC (400 mgs EGCG bid) vs. placebo: - Assess the safety of GTC (vs. Placebo) safety by evaluating incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0 (monthly), CBC, CMP, LFTs at baseline, year 1 and EOS. - Assess bioavailability as indicated by change in EGCG measured in plasma at baseline, year 1 and EOS. - Assess adherence and acceptability to agent by evaluating monthly percentage compliance using agent logs (%) and pill counts monthly. - Assess patient reported symptoms by evaluating change in scores in lower urinary tract symptoms and quality of life from baseline to EOS at baseline, year 1 and EOS. - Assess change in PSA and PSA kinetics (PSA, PSA doubling time and PSA density) from serum from baseline, 6, 12, 18 and EOS. - Assess the change in 17-gene expression panel (Oncotype Dx®) from baseline to EOS using biopsy tissue. - Assess the proportion of men with no cancer in the post-intervention biopsy from baseline to EOS. - Assess changes in the microbiome from baseline to post intervention - With consent of participating subjects, create a specimen repository (serum, stool and prostate biopsies) to test future hypotheses related to prostate cancer, as and when possible.
Sunphenon 90D/placebo ()