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Session IV: What Have We Learned From Clinical Trials

Session IV: What Have We Learned From Clinical Trials? Moderator: Dr. James Crowell, DCP, NCI.

A Randomized Pilot Clinical Trial of the Action (Independent Effects) of Isoflavones and Lycopene in Localized Prostate Cancer: Administration Prior to Radical Prostatectomy Dr. Nagi Kumar, H. Lee Moffitt Cancer Center

Dr. Kumar summarized the primary objective of this study is to assess the effect of supplementing patients with clinically localized prostate cancer, in the presurgical period prior to radical prostatectomy, with varying doses of isoflavones or lycopene on intermediate endpoint biomarkers (IEBs) of prostate cancer risk compared to a control group receiving no supplementation.

The IEBs are: 1) biochemical (serum levels of free and total testosterone, estradiol, and PSA); 2) proliferation (proliferating cell nuclear antigen, Ki-67 from prostate tissue); and 3) genetic/regulatory (apoptosis).

The secondary objectives are to: 1) assess the association between changes in plasma levels of isoflavones and lycopene with changes in the biochemical, proliferation, and genetic/regulator markers; and 2) test the hypothesis that men with the greatest increase in plasma levels of circulating isoflavones and lycopene will demonstrate the greatest reduction in IEBs of prostate cancer risk.

This is a controlled, randomized pilot study; the cohort is prostate cancer patients in the presurgical phase; the duration of intervention is from 4 to 6 wk; and the agents are isoflavones in 40, 60, and 80 mg doses and lycopene in 15, 30, and 45 mg doses. Sixty-seven subjects are participating in the pilot trial.

There are no results at this time.

2/05 NIH Meeting


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padSession IV: Lycopene for Androgen-Independent Prostate Ca
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February 2005 NIH
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padSession IV: Current NCI Clinical Lycopene Studies
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February 2005 NIH
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padSession IV: Intermed Endpoint Biomarkers & Lycopene in Men
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February 2005 NIH
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padSession IV: Changes in Molecular/Cell Morphology in Men
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February 2005 NIH
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padSession IV: Biomarkers for Predicting Response to Tomatoes
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February 2005 NIH
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padSession IV: Modifying Biomarkers of Oxidative Damage/DNA Repair
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February 2005 NIH
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padGroup Discussion IV: Defining Research Gaps/Setting Priorities
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February 2005 NIH
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