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Clinical Trial of Green Tea Catechins in Men on Active Surveillance

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04300855
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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
Prostate Cancer Prostate Adenocarcinoma Drug: Sunphenon Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)
Actual Study Start Date : August 10, 2020
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : April 15, 2024

Resource links provided by the National Library of Medicine


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 Name: Green Tea Catechin

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Occurrence of Adverse Events per Study Arm [ Time Frame: 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 1, 2, 3, 4, 5, 6 and q 3 months until end of intervention

  2. Adherence of Green Tea Catechins vs.Placebo [ Time Frame: Baseline to 24 months ]
    Adherence based on pill counts and agent logs

  3. Acceptability of Green Tea Catechins vs.Placebo [ Time Frame: Baseline to 24 months ]
    Acceptability based on pill counts and agent logs

  4. Change in (prostate-specific antigen) PSA and PSA kinetics [ Time Frame: 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

  5. Change in gene expression panel [ Time Frame: 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

  6. Proportion of men with no cancer [ Time Frame: Baseline to 24 months ]
    Assess the proportion of men with no cancer in the post-intervention biopsy



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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 in the most recent biopsy within last 6 months(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
  • Screening serum PSA <10 ng/mL or PSAD <0.15 ng/mL/g
  • 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 treated 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
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300855


Contacts
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Contact: Nagi Kumar, PhD, RD, FADA (813) 745-6885 Nagi.Kumar@moffitt.org

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Zara Kaur    (813) 745-1023    Zara.Kaur@moffitt.org   
Contact: Nagi Kumar, PhD, RD, FADA    (813) 745 6885    Nagi.Kumar@moffitt.org   
Sub-Investigator: Julio Pow-Sang, MD         
Sub-Investigator: Michael Poch, MD         
Sub-Investigator: Brandon Manley, MD         
Sub-Investigator: Roger Li, MD         
Sub-Investigator: Kosj Yamoah, MD         
Sub-Investigator: Kenneth Gage, MD, PhD         
Sub-Investigator: Christine Pierce, PhD         
Sub-Investigator: Michael Schell, PhD         
Sub-Investigator: Jasreman Dhillon, MD         
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Nagi Kumar, PhD, RD, FADA Moffitt Cancer Center
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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04300855    
Other Study ID Numbers: MCC-20056
1R01CA235032-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
Prostate
Green Tea
Green Tea Catechins
Additional relevant MeSH terms:
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Adenocarcinoma
Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type