NCT01105338

Lycopene or Green Tea for Men at Risk of Prostate Cancer

Lycopene or Green Tea a Feasibility Study in Men at Risk of Prostate Cancer

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 126 (actual)
• Sponsor: University of Bristol · Academic / Other
• Sex: Male
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

Summary

RATIONALE: Lycopene and green tea may stop or delay the development of recurrent prostate cancer in patients has been treated for prostate cancer. It is not yet known whether lycopene or green tea may be more effective in preventing prostate cancer. PURPOSE: This randomized phase II trial is studying lycopene to see how well it works compared with green tea in preventing prostate cancer in patients previously enrolled in the ProtecT trial

Detailed description

OBJECTIVES: Primary * To assess serum lycopene and epigallocatechin-3-gallate (green tea) levels at 6 months following randomization in patients with prostate cancer previously enrolled on ProtecT Secondary * To evaluate trial recruitment and randomization rates of patients treated with this regimen. * To evaluate intervention tolerability in patients treated with this regimen. * To evaluate compliance of patients treated with this regimen. * To evaluate trial retention of patients treated with this regimen. * To assess PSA values in patients treated with this regimen. * To evaluate dietary compliance with recommendations of patients treated with this regimen. * To assess weight and body mass index of patients treated with this regimen. * To evaluate attitudes and views of men and their spouses about dietary modification and participation in long-term study. OUTLINE: Patients are stratified according to PSA test levels obtained from ProtecT study recruitment clinic (\< 3.0 ng/mL vs 3.0-19.99 ng/mL). Patients are randomized to 1 of 2 treatment arms.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Green tea drink	Green tea drink
DIETARY_SUPPLEMENT	green tea capsules	green tea capsules
OTHER	Green tea placebo capsules	Green tea placebo capsules
DIETARY_SUPPLEMENT	Lycopene capsules	Lycopene capsules
OTHER	Lycopene placebo capsules	Lycopene placebo capsules
OTHER	Tomato rich diet	Tomato rich diet

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-08-01
• Completion: 2010-08-01
• First posted: 2010-04-16
• Last updated: 2018-01-23

Locations

1 site across 1 country: United Kingdom