Phase 2 Trial of Genistein in Men With Circulating Prostate Cancer Cells
PRIMARY OBJECTIVES:
I. Determine whether genistein treatment will decrease the number of circulating prostate
cells (CPCs) in the peripheral blood as measured by qRT-PCR for PSA performed on RNA
extracted from peripheral blood mononuclear cells (PBMNCs).
SECONDARY OBJECTIVES:
I. Determine the natural history of circulating prostate cells (CPCs) in a cohort of
subjects prior to and post radical prostatectomy.
II. Compare the measurement of PSA between three separate methods: in CPCs by qRT-PCR, in
serum by the standard clinical chemistry assay (i.e., ELISA), and in plasma and serum by the
nano-PSA assay.
III. Measure the effect of genistein on gene and protein expression in prostate tissue by
qRT-PCR and immunohistochemistry, respectively, for the following genes and their respective
protein products: HSP27, MMP-2, ALK-2, BASP1, and HCF2.
OUTLINE:
Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral genistein once daily for 3 months beginning at least 1 month
prior to radical prostatectomy.
ARM II: Patients receive oral placebo once daily for 3 months beginning at least 1 month
prior to radical prostatectomy.
All patients undergo radical prostatectomy at least 2 weeks, but not more than 3 months
following the start of therapy.
After completion of study treatment, patients are followed at 1, 6, and 12 months.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Determine whether genistein will decrease number of circulating prostate cells (CPCs) in the blood as determined by qRT-PCR for PSA on RNA extracted from PBMNCs
Blood will be collected to analyze the number of CPC's at screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery.
At screening, after 1-month of treatment, at surgery and at 1 and 12 months after surgery
No
William Catalona
Principal Investigator
Northwestern University
United States: Institutional Review Board
NCI 09U2
NCT01126879
May 2010
May 2015
Name | Location |
---|---|
Northwestern University | Chicago, Illinois 60611 |