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.
Biopsy-proven (consisting of ≥ 12 tissue cores) adenocarcinoma of the prostate with cancer present in at least one biopsy core (TRUS or/and mpMRI/TRUS fusion), Gleason score (3+3) or predominant Gleason pattern 3 (3+4), ≤ 33% of biopsy cores, and > Willing to start or continue on active surveillance
Screening serum PSA > No other prior treatment for PCa, including focal therapy
ECOG performance status 0−1
No history of renal or hepatic disease, including history of hepatitis B and C
Meet hematological eligibility parameters (Neutrophil count > 1,200/mm3 (≥1.2 k/μL), Stable platelet count > 75,000/mm3 (> 75k/μL) Hepatic and renal function eligibility parameters, serum total Bilirubin > Willing to abstain from consumption of any supplements containing GTC
Willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week
Willing to discontinue current vitamin/mineral supplement use and use one provided by study
Willing to take study agent or placebo at the dose specified with meals
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