Clinical trial · Interventional
Defined Green Tea Catechins in Treating Patients With Prostate Cancer Undergoing Surgery to Remove the Prostate
Phase Ib Study of Polyphenon E in a Pre-prostatectomy Prostate Cancer Cohort
NCT00459407CI-TRIAL-00015809completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Green tea extract contains ingredients that may prevent or slow the growth of prostate cancer. This phase I trial is studying how well green tea extract works in treating patients with prostate cancer undergoing surgery to remove the prostate
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| biopsy | Procedure | — | UNRESOLVED |
| defined green tea catechin extract | Dietary Supplement | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (green tea catechin extract)
- description
- Patients receive oral defined green tea catechin extract daily for 4-7 weeks. All patients undergo surgery one day after the last dose of study agent.
- interventionNames
- Dietary Supplement: defined green tea catechin extract
- Other: immunohistochemistry staining method
- Other: immunoenzyme technique
- Other: laboratory biomarker analysis
- Procedure: biopsy
- Other: mass spectrometry
- Other: high performance liquid chromatography
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive oral placebo daily for 4-7 weeks. All patients undergo surgery one day after the last dose of study agent.
- interventionNames
- Drug: placebo
- Other: immunohistochemistry staining method
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Criteria: * Biopsy-proven adenocarcinoma of the prostate meeting the following criteria: organ-confined disease; treatable by prostatectomy * PSA \< 50 ng/mL * ECOG performance status (PS) 0-1 or Karnofsky PS 70-100% * Bilirubin normal * AST and ALT normal * Creatinine normal * Fertile patients must use effective contraception * No uncontrolled intercurrent illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness or social situations that would limit study compliance * No history of allergic reactions attributed to compounds of similar chemical or biologic composition to green tea extract * No prior therapy for prostate cancer (i.e., hormone therapy, radiation therapy, or surgery) * No systemic treatment (chemotherapy) and/or radiation therapy for any malignancy within the past 5 years (excluding nonmelanoma skin cancer or cancer confined to organs with surgical removal as the only treatment) * No regular tea consumption (\> 6 servings of hot tea or 12 servings of iced tea or equivalent combination per week) within the past month * No other concurrent investigational agents * No other concurrent consumption of tea or tea-derived products from green, black, or oolong tea
References
Publications (1)
- DERIVEDNguyen MM, Ahmann FR, Nagle RB, Hsu CH, Tangrea JA, Parnes HL, Sokoloff MH, Gretzer MB, Chow HH. Randomized, double-blind, placebo-controlled trial of polyphenon E in prostate cancer patients before prostatectomy: evaluation of potential chemopreventive activities. Cancer Prev Res (Phila). 2012 Feb;5(2):290-8. doi: 10.1158/1940-6207.CAPR-11-0306. Epub 2011 Nov 1. PMID 22044694