Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Enrollment
- 115
- Locations
- 2
- Primary Endpoint
- Rate of Progression to Prostate Cancer (PCa)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts 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.
Arms & Interventions
Sunphenon® 90D
Participants will be administered a standardized formulation of whole Green Tea Catechin for 24 months. The daily dose of Green Tea Catechin will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.
Intervention: Sunphenon (Drug)
Placebo
Participants will be administered a placebo for 24 months. The daily dose of placebo will be taken in divided doses, three capsules in the morning and 3 capsules in the evening, with food (within one hour of eating a substantial meal). On the day of monthly follow-up visit, capsules should be taken within 4 hours of visit and blood draw for required lab work. If the participant is scheduled to come in the afternoon, dose should be taken with lunch that day instead of with dinner for that day.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Rate of Progression to Prostate Cancer (PCa)
Time Frame: 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 Outcomes
- Occurrence of Adverse Events per Study Arm(Base line to 24 months)
- Adherence of Green Tea Catechins vs.Placebo(Baseline to 24 months)
- Acceptability of Green Tea Catechins vs.Placebo(Baseline to 24 months)
- Change in (prostate-specific antigen) PSA and PSA kinetics(Baseline to 24 months)
- Change in gene expression panel(Baseline to 24 months)
- Proportion of men with no cancer(Baseline to 24 months)