NCT00005828

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

A Phase II Trial of Green Tea Extract in the Treatment of Androgen-Independent Metastatic Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Green tea extract contains substances that may slow the growth of certain cancers and may prevent the development of new cancers. PURPOSE: Phase II trial to determine the effectiveness of green tea extract in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.

Detailed description

OBJECTIVES: I. Determine the effectiveness and toxicity of green tea extract in patients with androgen-independent metastatic prostate cancer. II. Determine the response rate and response duration in patients treated with this regimen. III. Determine whether a decline in prostate-specific antigen (PSA) coincides with evidence of disease regression in these patients. OUTLINE: 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.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	green tea extract

Timeline

• Start date: 2000-12-01
• Primary completion: 2003-03-01
• Completion: 2008-06-01
• First posted: 2004-04-20
• Last updated: 2016-07-13

Locations

16 sites across 1 country: United States