Conditions

Prostate Cancer

Keywords

stage IV prostate cancerrecurrent prostate cancer

Outcome Measures

Primary Outcomes (2)

Response rate and duration
Up to 5 years
Disease-regression
Up to 5 years

Study Arms (1)

green tea extract

EXPERIMENTAL

Patients receive oral green tea extract six times daily for 4 months. Patients with a 50% decline in PSA, complete or partial response, or stable disease after 4 months continue treatment in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 4 months receive no further treatment. Patients are followed every 3 months for 5 years or until disease progression. If disease progression, patients are followed every 6 months for 5 years.

Dietary Supplement: green tea extract

Interventions

green tea extractDietary supplement

green tea extract

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Clinically proven androgen-independent metastatic prostate cancer Radiological, physically palpable, and/or biochemical evidence of progression Increase in PSA after orchiectomy or hormonal treatment No symptoms directly attributable to metastatic disease No CNS metastases or carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Not specified Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 2 times upper limit of normal Cardiovascular: No uncontrolled high blood pressure No unstable angina No symptomatic congestive heart failure No uncontrolled cardiac arrhythmias No myocardial infarction in past 6 months Other: No other malignancy within the past 5 years except basal cell skin cancer No uncontrolled diabetes mellitus or inability to tolerate high sugar content of green tea at discretion of oncologist No other medical or psychiatric conditions that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy Chemotherapy: At least 4 weeks since prior chemotherapy No concurrent chemotherapy Endocrine therapy: At least 4 weeks since prior flutamide or megestrol At least 6 weeks since prior longer-acting hormonal agents such as bicalutamide At least 4 weeks since prior hormonal therapy, except luteinizing hormone- releasing hormone agonist No concurrent hormonal therapy, including corticosteroids for cancer treatment Radiotherapy: No concurrent radiotherapy Surgery: See Disease Characteristics Other: No other concurrent investigational agents

Sponsors & Collaborators

Alliance for Clinical Trials in Oncology
Otherlead
National Cancer Institute (NCI)
NIHcollaborator

Study Sites (16)

CCOP - Scottsdale Oncology Program

Scottsdale, Arizona, 85259-5404, United States

CCOP - Illinois Oncology Research Association

Peoria, Illinois, 61602, United States

CCOP - Carle Cancer Center

Urbana, Illinois, 61801, United States

CCOP - Cedar Rapids Oncology Project

Cedar Rapids, Iowa, 52403-1206, United States

CCOP - Iowa Oncology Research Association

Des Moines, Iowa, 50309-1016, United States

Siouxland Hematology-Oncology

Sioux City, Iowa, 51101-1733, United States

CCOP - Wichita

Related Publications (1)

Jatoi A, Ellison N, Burch PA, Sloan JA, Dakhil SR, Novotny P, Tan W, Fitch TR, Rowland KM, Young CY, Flynn PJ. A phase II trial of green tea in the treatment of patients with androgen independent metastatic prostate carcinoma. Cancer. 2003 Mar 15;97(6):1442-6. doi: 10.1002/cncr.11200.
PMID: 12627508RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Tea

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological Products

Study Officials

Aminah Jatoi, MD
Mayo Clinic
STUDY CHAIR

Green Tea Extract in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

Primary Completion

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

green tea extract

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (16)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

Primary Completion

First Posted

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Study Arms (1)

green tea extract

Interventions

Eligibility Criteria

Sponsors & Collaborators

Study Sites (16)

Related Publications (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations