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NCT04597359 · ClinicalTrials.gov registry record · Phase 2
To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring
A Phase 2 study of Prostate Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
- Active
- Registry status
- Phase 2
- Development phase
- 360
- Enrollment target
- 20
- Study locations
NCT04597359: Active Phase 2 study of Prostate Carcinoma, sponsored by ECOG-ACRIN Cancer Research Group.
NCT04597359 is a Phase 2 study of Prostate Carcinoma that is active but no longer recruiting, run by ECOG-ACRIN Cancer Research Group. The registered enrollment target is 360 participants, below the 1,496-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04597359, a Phase 2 study of Prostate Carcinoma, is active but no longer recruiting, sponsored by ECOG-ACRIN Cancer Research Group.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 360 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.
Primary Outcome
Measured in a core positive for tumor from baseline to highest percent (%) Ki-67 expression measured in a core positive for tumor in the end of study (EOS) biopsy. This change will be compared between green tea catechins (GTC) and placebo arms. The highest % Ki-67 expressions from baseline and EOS biopsies will be used to estimate the change. If the change is not normally distributed, non-parametric test such as Wilcoxon-rank sum test or two-sample normal score test will be used to compare the c
Conditions Studied
Interventions
- OTHER Quality-of-Life Assessment
- OTHER Questionnaire Administration
- DRUG Placebo Administration
- DRUG Sinecatechins
Study Locations (20)
California
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Marshall Cancer Center - Cameron Park
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Epic Care-Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
- Bay Area Breast Surgeons Inc - Emeryville
- Epic Care Partners in Cancer Care - Emeryville
- UC San Diego Health System - Encinitas - Encinitas
- UC San Diego Moores Cancer Center - La Jolla
- Contra Costa Regional Medical Center - Martinez
- Mercy Cancer Center - Merced
Arkansas
- Highlands Oncology Group - Fayetteville - Fayetteville
- Mercy Hospital Fort Smith - Fort Smith
- CHI Saint Vincent Cancer Center Hot Springs - Hot Springs
- CARTI Cancer Center - Little Rock
- Highlands Oncology Group - Rogers - Rogers
- Highlands Oncology Group - Springdale
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Arizona
- Cancer Center at Saint Joseph's - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 360 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2032-12-31 |
| Phase | Phase 2 |
What the registry record for NCT04597359 still lists
NCT04597359 is an interventional study that assigns participants to a tested intervention. The registered 360 participants enrollment target is mid-sized for trials with a published cap, below the 1,496-participant average among 59 other Prostate Carcinoma trials with a reported enrollment target (76% lower).
The record links to 1 condition, with Prostate Carcinoma appearing as the primary indexed condition, and to 4 interventions - of which Quality-of-Life Assessment is the first listed.
NCT04597359 names 20 study sites across 4 states, led by California, Arkansas, Alaska.
Frequently Asked Questions
What is clinical trial NCT04597359 about?
NCT04597359 is a clinical study titled "To Evaluate if Green Tea Can be Effective in Reducing the Progression of Prostate Cancer in Men on Close Monitoring". This phase II trial studies how well green tea catechins work in preventing progression of prostate cancer from a low risk stage to higher risk stages in men who are on active surveillance. Green tea catechins may stabilize prostate cancer and lower the chance of prostate growing.
What is the current status of trial NCT04597359?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 360 participants. The study started on 2021-10-05. Estimated completion is 2032-12-31.
What conditions does trial NCT04597359 study?
This clinical trial studies the following conditions: Prostate Carcinoma.
What interventions are being tested in trial NCT04597359?
The interventions under investigation include: Quality-of-Life Assessment (OTHER), Questionnaire Administration (OTHER), Placebo Administration (DRUG), Sinecatechins (DRUG).
Who is sponsoring clinical trial NCT04597359?
This trial is sponsored by ECOG-ACRIN Cancer Research Group, which has 75 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04597359 being conducted?
This trial has 20 study locations across Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Prostate Carcinoma
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 NCT04597359's enrollment target sits among peer trials
360 10th of 59 higher than 50 of 59 other Prostate Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Carcinoma 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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