Clinical Trial of Green Tea Catechins in Men on Active Surveillance
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: Sunphenon
The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months
Other Names:
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| Placebo Comparator: 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. |
Drug: Placebo
Matching placebo
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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18 years of age or older
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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)
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Willing to start or continue on active surveillance
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Screening serum PSA <10 ng/mL or PSAD <0.15 ng/mL/g
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No other prior treatment for PCa, including focal therapy
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ECOG performance status 0-1
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No history of renal or hepatic disease, including history of hepatitis B and C
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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
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Willing to abstain from consumption of any supplements containing GTC
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Willing to restrict tea consumption to less than three (3) servings of hot tea or three (3) servings of iced tea per week
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Willing to discontinue current vitamin/mineral supplement use and use one provided by study
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Willing to take study agent or placebo at the dose specified with meals.
Exclusion Criteria:
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Have had prior treatment for PCa by surgery, irradiation, local ablative (i.e., cryosurgery or high-intensity focused ultrasound), or androgen-deprivation therapy)
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Men treated with 5- alpha-reductase inhibitors (e.g., finasteride, dutasteride)
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Participants who have PCa with distant metastases
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Participants who have been treated with: hormone therapy, immunotherapy, chemotherapy and/or radiation, for any malignancies within the past 2 years
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Participants may not be receiving any other investigational agents
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History of allergic reactions attributed to tea or compounds of similar chemical or biologic composition to green tea extracts.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Moffitt Cancer Center | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Nagi Kumar, PhD, RD, FADA, Moffitt Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-20056
- 1R01CA235032-01A1