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Randomized Study of Sunphenon Decaffeinated Capsules in Men With Low-Risk Prostate Cancer on Active Surveillance
This randomized phase II trial studies how well green tea extract works in treating patients with low-risk prostate cancer. Green tea extract contains ingredients that may prevent or slow the growth of certain cancers.
PRIMARY OBJECTIVES: I. To assess changes in the levels of total- and free- prostate-specific antigen (PSA), free to total PSA (f/tPSA) ratio and insulin-like growth factor 1 (IGF-I) levels and IGF-I/free PSA (fPSA) ratio, insulin-like growth factor binding protein 3 (IGFBP-3), and vascular endothelial growth factor (VEGF) after Sunphenon 90DCF-T (green tea extract) supplementation during the period between recruitment and biopsy. SECONDARY OBJECTIVES: I. To evaluate the effects of oral ingestion on Sunphenon 90DCF-T supplementation during the period between recruitment and biopsy in the reactivation of glutathione S-transferase pi 1 (GSTP1) (whole blood deoxyribonucleic acid \[DNA\]); levels of antigen identified by monoclonal antibody Ki-67 (Ki-67), cluster of differentiation 34 (CD34), and M30 apopotosense in the prostate tissue. II. To evaluate the effects of oral ingestion of Sunphenon 90DCF-T during the period between recruitment and biopsy on histologic findings in prostate tissue such as nuclear measurements viz. shape, size and texture and quality of life (QOL) assessment. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM A: Patients undergo active surveillance for 52 weeks. ARM B: Patients receive green tea extract orally (PO) once daily (QD) for 52 weeks in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days.
Age
45 - 85 years
Sex
MALE
Healthy Volunteers
No
University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Start Date
August 30, 2013
Primary Completion Date
October 5, 2016
Completion Date
November 7, 2016
Last Updated
October 22, 2020
6
ACTUAL participants
active surveillance
OTHER
Sunphenon
DRUG
laboratory biomarker analysis
OTHER
Questionnaire Administration
OTHER
Lead Sponsor
Sanjay Gupta PhD
NCT05334069
NCT06205316
Data Source & Attribution
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