This randomized phase II trial studies cholecalciferol and genistein compared to placebo in treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow the growth of cancer cells and may be an effective treatment for prostate cancer.
PRIMARY OBJECTIVES: I. To determine differences in prostate tissue steady state concentrations of calcitriol in participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which provides 600 mg of genistein) and those receiving placebo. SECONDARY OBJECTIVES: I. To determine the effect of each intervention arm and resulting prostate tissue levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily (QD) on days 1-21 or 1-28. Patients then undergo prostatectomy. ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
15
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Maryland, United States
Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms
This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein
Time frame: up to Day 35
Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms
To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein
Time frame: up to 35 days
Levels of Calcidiol in the Participants Serum
This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study
Time frame: Baseline and up to day 35
Levels of Calcitriol in Participants Serum
This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.
Time frame: baseline and Up to Day 35
PBMC CYP mRNA Expression of CYP24
This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein.
Time frame: Baseline and Up to Day 35
PBMC CYP mRNA Expression of CYP27B1
This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein.
Time frame: Up to Day 35
Total PSA in Serum
This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study.
Time frame: at Baseline and up to Day 35
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Correlative studies
Given PO
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States
University of Rochester
Rochester, New York, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology San Antonio Research PA
San Antonio, Texas, United States
...and 1 more locations
Serum Calcium Levels at Baseline and Pre-Surgery
This is a measurement of calcium in the Blood serum at baseline and at the end of the study.
Time frame: Baseline and Day 35
Total IGF-1 in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study.
Time frame: Baseline and up to Day 35
Total IGF-2 in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study
Time frame: Baseline and Up to Day 35
Total IGFBP-3 in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study.
Time frame: Baseline and Up to Day 35
Total PTH in Serum at Baseline and Pre-Surgery
This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study
Time frame: Baseline and Up to Day 35
Immunohistochemistry Measurements in Benign Prostate Tissue (BPT)
The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm) This is to serve as normalized control data to determine expression of protein. The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer). This Optical Density is based on fluorescence.
Time frame: Up to Day 35
Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA)
The Immunohistochemistry measurement for: AR (Nucleus), VDR (Cytoplasm), p21 (Nucleus), PGE2 (Cytoplasm), TUNEL Pos (Nucleus), Caspase 3 (Cytoplasm), PSMA (Cytoplasm), IGF-1 and IGF-2 (Cytoplasm), Akt (Nucleus and Cytoplasm), and pAkt (nucleus and Cytoplasm) This is to serve as normalized case data to determine expression of protein. The normalized optical densities were measured as optical density per unit area by densitometric scanning using Vectra imaging system (Perkin Elmer). This Optical Density is based on fluorescence.
Time frame: Up to day Day 35
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
Time frame: up to Day 35