NCT00042731

Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy

A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: Male
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer. PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.

Detailed description

OBJECTIVES: * Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer. * Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients. * Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients. * Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients. * Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups. PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lycopene	Daily administration as outlined in treatment arm(s)
DIETARY_SUPPLEMENT	Multivitamin	Daily administration as outlined in treatment arm(s)
DIETARY_SUPPLEMENT	Soy isoflavones	Daily administration as outlined in treatment arm(s)

Timeline

• Start date: 2002-07-01
• Primary completion: 2006-08-01
• Completion: 2006-08-01
• First posted: 2003-01-27
• Last updated: 2012-09-24

Locations

5 sites across 1 country: United States