Clinical Trials /

Clinical Trial of Green Tea Catechins in Men on Active Surveillance

NCT04300855

Description:

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

Related Conditions:
  • Prostate Adenocarcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Clinical Trial of Green Tea Catechins in Men on Active Surveillance
  • Official Title: Phase II Clinical Trial of Green Tea Catechins in Men on Active Surveillance (AS)

Clinical Trial IDs

  • ORG STUDY ID: MCC-20056
  • SECONDARY ID: 1R01CA235032-01A1
  • NCT ID: NCT04300855

Conditions

  • Prostate Cancer
  • Prostate Adenocarcinoma

Interventions

DrugSynonymsArms
SunphenonGreen Tea CatechinSunphenon® 90D
PlaceboPlacebo

Purpose

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 400 mgs vs. Placebo, administered for 24 months in a cohort of men with low to intermediate grade prostate managed on active surveillance

Trial Arms

NameTypeDescriptionInterventions
Sunphenon® 90DExperimentalParticipants 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.
  • Sunphenon
PlaceboPlacebo ComparatorParticipants 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.
  • Placebo

Eligibility Criteria

        Inclusion Criteria:

          -  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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:21 Years
Eligible Gender:Male
Healthy Volunteers:No

Primary Outcome Measures

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

Measure:Occurrence of Adverse Events per Study Arm
Time Frame:Base line to 24 months
Safety Issue:
Description: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
Measure:Adherence of Green Tea Catechins vs.Placebo
Time Frame:Baseline to 24 months
Safety Issue:
Description:Adherence based on pill counts and agent logs
Measure:Acceptability of Green Tea Catechins vs.Placebo
Time Frame:Baseline to 24 months
Safety Issue:
Description:Acceptability based on pill counts and agent logs
Measure:Change in (prostate-specific antigen) PSA and PSA kinetics
Time Frame:Baseline to 24 months
Safety Issue:
Description: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
Measure:Change in gene expression panel
Time Frame:Baseline to 24 months
Safety Issue:
Description: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
Measure:Proportion of men with no cancer
Time Frame:Baseline to 24 months
Safety Issue:
Description:Assess the proportion of men with no cancer in the post-intervention biopsy

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:H. Lee Moffitt Cancer Center and Research Institute

Trial Keywords

  • Prostate
  • Green Tea
  • Green Tea Catechins

Last Updated

March 6, 2020