Clinical trial · Interventional
Defined Green Tea Catechin Extract in Treating Patients With Localized Prostate Cancer Undergoing Surgery
Phase II, Randomized, Double Blind, Placebo Controlled Pilot Study of Polyphenon E in Men With Localized Prostate Cancer Scheduled to Undergo Radical Prostatectomy
NCT01340599CI-TRIAL-00006491terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual
Summary
Brief summary (as posted)
This randomized pilot phase II trial studies the side effects and how well defined green tea catechin extract works in treating patients with localized prostate cancer undergoing surgery. Defined green tea catechin extract contains ingredients that may prevent or slow the growth of certain cancers.
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 |
|---|---|---|---|
| Stage IIA Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB 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 |
|---|---|---|---|
| defined green tea catechin extract | Dietary Supplement | — | UNRESOLVED |
| high performance liquid chromatography | Other | — | UNRESOLVED |
| immunoenzyme technique | Other | — | UNRESOLVED |
| immunohistochemistry staining method | Other | — | UNRESOLVED |
| mass spectrometry | Other | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Polyphenon E)
- description
- Patients receive defined green tea catechin extract PO once daily QD for 4-10 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo radical prostatectomy between days 28-70.
- interventionNames
- Dietary Supplement: defined green tea catechin extract
- Other: immunohistochemistry staining method
- Other: immunoenzyme technique
- Other: questionnaire administration
- Procedure: therapeutic conventional surgery
- Other: high performance liquid chromatography
- Other: mass spectrometry
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO QD for 4-10 weeks in the absence of disease progression or unacceptable toxicity. Patients undergo radical prostatectomy between days 28-70.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Prostate biopsy positive for cancer; clinically localized T1 and T2 stage disease expected, with biopsy specimen available for baseline biomarker measurements * Scheduled for a radical prostatectomy * Willing to sign an Institutional Review Board (IRB)-approved informed consent document and adhere to the protocol * Willing and able to take oral medications * Willing to refrain from drinking any kind of tea (including herbal tea) or using supplements containing green tea constituents for the duration of the study Exclusion Criteria: * Prior hormonal or surgical therapy for prostate cancer; including prior brachytherapy or radiation therapy * Recent consumption of tea (six or more cups per day) or use of supplements containing green tea within one week of randomization * Signs or symptoms of progressive or uncontrolled renal, hepatic, hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease * Serum creatinine \>= 1.5 x upper limit of normal (ULN) * Alanine aminotransferase (ALT) \>= ULN * Aspartate aminotransferase (AST) \>= ULN * Alkaline phosphatase (ALP) \>= ULN * Albumin (ALB) =\< lower limit of normal (LLN) * Total bilirubin \>= ULN * Known malignancy at any site within the last five years; with the exception of basal cell carcinoma (BCC) * Participation in a research trial within the past three months * Any condition that would interfere with the ability to give informed consent or comply with the study protocol * Hypersensitivity to tea products or any of the inactive ingredients found in the drug product capsules * Concomitant use of at least 400 mg per day of a nonsteroidal anti-inflammatory (NSAID) agent two or more times per week
References
Publications (0)
Data not yet available
No reference posted for this study.