Prostate Adenocarcinoma, Prostate Cancer
Conditions
Keywords
Prostate, Green Tea, Green Tea Catechins
Brief summary
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 405 mgs vs. Placebo, administered for 24 months in a cohort of men with low to intermediate grade prostate managed on active surveillance
Interventions
DRUGSunphenon
The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months
DRUGPlacebo
Matching placebo
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Participants participating in the study will be randomized 2:1 (2 study agent: 1 placebo) to receive Sunphenon® 90D (405 mg EGCG BID) or placebo.
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age or older * 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 ≤50% involvement of any biopsy core (Participant meets all criteria for Active Surveillance as determined by MD) * Willing to start or continue on active surveillance * Baseline/screening serum PSA \<10 ng/mL * 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 ≤ULN (ULN: 1.2 mg/dl) (or ≤3.0 mg/dL for patients with Gilbert's syndrome), AST or ALT \<1.5x ULN and Serum creatinine ≤1.5 x ULN * 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.
Exclusion criteria
* Have had prior treatment for PCa by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy) * Men who are currently treated or those treated in the past 3 months prior to day of randomization with 5- alpha-reductase inhibitors (e.g., finasteride, dutasteride) * Participants who have PCa with distant metastases * Participants who have been treated with: hormone therapy, immunotherapy, chemotherapy and/or radiation, for any malignancies within the past 2 years prior to registration.Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. All patients with metastatic disease will be excluded * Participants may not be receiving any other investigational agents * History of allergic reactions attributed to tea or compounds of similar chemical or biologic composition to green tea extracts.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Progression to Prostate Cancer (PCa) | 24 months | Number of participants with 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 biopsy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Adverse Events per Study Arm | Base line to 24 months | Safety of Green Tea Catechins (GTC) at daily dose (vs. Placebo) as indicated by incidence of adverse events and toxicities, monitored using Common Toxicity Criteria version 5.0, complete blood count (CBC), and complete metabolic panel (CMP) from baseline, month 6, month 12 and month 24 at end of trial, Liver toxicities (LFTs) from baseline, month 3, 6 and every 3 months until end of intervention |
| Adherence of Green Tea Catechins vs.Placebo | Baseline to 24 months | Adherence based on pill counts and agent logs |
| Acceptability of Green Tea Catechins vs.Placebo | Baseline to 24 months | Acceptability based on pill counts and agent logs |
| Change in (prostate-specific antigen) PSA and PSA kinetics | Baseline to 24 months | PSA or PSA density and PSA doubling time at month 12 and at 24 months) from serum at baseline, 6, 12, 18 and month 24 |
| Change in gene expression panel | Baseline to 24 months | Asses change in gene expression panel (Decipher) and a set of 13 biomarker genes known to be overexpressed in PCa from baseline to end of study (EOS) using biopsy tissue |
| Proportion of men with no cancer | Baseline to 24 months | Assess the proportion of men with no cancer in the post-intervention biopsy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNagi Kumar, PhD RD FADA
Moffitt Cancer Center
Outcome results
None listed