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NCT04300855 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Green Tea Catechins in Men on Active Surveillance
A Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 115
- Enrollment target
- 2
- Study locations
NCT04300855: Active Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
NCT04300855 is a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma that is active but no longer recruiting, run by H. Lee Moffitt Cancer Center and Research Institute. The registered enrollment target is 115 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04300855, a Phase 2 study of Prostate Cancer and Prostate Adenocarcinoma, is active but no longer recruiting, sponsored by H. Lee Moffitt Cancer Center and Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 115 participants
- Enrollment target
- 2
- Study locations
Study 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
Primary Outcome
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sunphenon
Study Locations (2)
Florida
- Moffitt Cancer Center - Tampa
Kansas
- University of Kansas Cancer Center - Westwood
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 115 participants |
| Start Date | 2020-08-21 |
| Est. Completion | 2027-02-27 |
| Phase | Phase 2 |
What the registry record for NCT04300855 still lists
NCT04300855 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (81% lower).
The record links to 2 conditions, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT04300855 reports a single indexed study location in Florida, Kansas.
Frequently Asked Questions
What is clinical trial NCT04300855 about?
NCT04300855 is a clinical study titled "Clinical Trial of Green Tea Catechins in Men on Active Surveillance". 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 w...
What is the current status of trial NCT04300855?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 115 participants. The study started on 2020-08-21. Estimated completion is 2027-02-27.
What conditions does trial NCT04300855 study?
This clinical trial studies the following conditions: Prostate Cancer, Prostate Adenocarcinoma.
What interventions are being tested in trial NCT04300855?
The interventions under investigation include: Placebo (DRUG), Sunphenon (DRUG).
Who is sponsoring clinical trial NCT04300855?
This trial is sponsored by H. Lee Moffitt Cancer Center and Research Institute, which has 502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04300855 being conducted?
This trial has 2 study locations across Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04300855's enrollment target sits among peer trials
115 315th of 735 higher than 421 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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