A Phase 2 interventional study of Sunphenon and Placebo in Prostate Cancer and Prostate Adenocarcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Active, not recruiting at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-01.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Other
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
6,367 studies on the registry are indexed under Prostatic Neoplasms; 1,397 are open to participants now.
This study's enrollment of 115 is above the median of 58 across 4,821 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Exclusion Criteria:
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
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
The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months
Also known as: Green Tea Catechin
Matching placebo
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
Time frame: 24 months
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
Time frame: Base line to 24 months
Adherence of Green Tea Catechins vs.Placebo
Adherence based on pill counts and agent logs
Time frame: Baseline to 24 months
Acceptability of Green Tea Catechins vs.Placebo
Acceptability based on pill counts and agent logs
Time frame: Baseline to 24 months
Change in (prostate-specific antigen) PSA and PSA kinetics
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
Time frame: Baseline to 24 months
Change in gene expression panel
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
Time frame: Baseline to 24 months
Proportion of men with no cancer
Assess the proportion of men with no cancer in the post-intervention biopsy
Time frame: Baseline to 24 months
Plan to share: Undecided
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This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute