Clinical Trial of Green Tea Catechins in Men on Active Su... | NCT04300855

NCT04300855

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
1R01CA235032-01A1	U.S. NIH Grant/Contract		View source

Status Module

Name	Class
National Cancer Institute (NCI)	NIH

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sunphenon® 90D	Experimental	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
Placebo	Placebo Comparator	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sunphenon	Drug	The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months	Sunphenon® 90D

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Rate of Progression to Prostate Cancer (PCa)	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	24 months

Secondary Outcomes

Measure	Description	Time Frame
Occurrence of Adverse Events per Study Arm	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

Eligibility Module

Eligibility Criteria

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.

Facility	Status	City	State	ZIP	Country	Contacts
Moffitt Cancer Center		Tampa	Florida	33612	United States
University of Kansas Cancer Center