Status:
ACTIVE_NOT_RECRUITING
Clinical Trial of Green Tea Catechins in Men on Active Surveillance
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Cancer
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
PHASE2
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 Catech...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2027
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT04300855
Start Date
August 21 2020
End Date
February 27 2027
Last Update
October 3 2025
Active Locations (2)
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1
Moffitt Cancer Center
Tampa, Florida, United States, 33612
2
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205