Phase 2
Completed N=33
Green Tea Extract and Prostate Cancer
Source: ClinicalTrials.gov NCT00676780 ↗Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Aug 2012
Primary outcomePrimary: Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer — 0.86 ng/mL — p==0.027
Summary
The purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Serum Prostate Specific Antigen (PSA) of Prostate Cancer |
0.86 | =0.027 sig |
| PRIMARY Change in Serum Vascular Endothelial Growth Factor (VEGF) and Prostate Cancer. |
26.8 | 0.023 sig |
| PRIMARY Change in Serum Hepatocyte Growth Factor (HGF) and Prostate Cancer. |
96.67 | <0.001 sig |
Eligibility Criteria
Inclusion Criteria
- recent biopsy positive for prostate cancer
- scheduled for prostatectomy
- must be able to swallow capsules
- Palpable mass by digital rectal examination (DRE)
- Ability to give informed consent and willingness to adhere to study protocol
- Age ≥ 18 years and less than 75
Exclusion Criteria
- abnormal liver function
- Prior hormonal or surgical therapy for prostate cancer
- Liver or kidney problems that would interfere with metabolism of study drug
- Any condition that would hamper informed consent or ability to comply with study protocol
- Participation in another research study in the last three months
- Known malignancy at any site other than prostate
- Recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)
Data sourced from ClinicalTrials.gov (NCT00676780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.