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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00451 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| UWI09-14-01 | |||
| CDR0000698228 | |||
| CO-10805 | |||
| CO 10805 | Other Identifier | University of Wisconsin Hospital and Clinics | |
| UWI09-14-01 | Other Identifier | DCP | |
| N01CN35153 | U.S. NIH Grant/Contract | View source | |
| P30CA014520 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (cholecalciferol, genistein) | Experimental | Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cholecalciferol | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | up to 35 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline and up to day 35 |
| Levels of Calcitriol in Participants Serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Jarrard | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham Cancer Center | Birmingham | Alabama | 35233 | United States | ||
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm II (Placebo) | Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO |
| FG001 | Arm I (Cholecalciferol, Genistein) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Genistein | Drug | Given PO |
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| Laboratory Biomarker Analysis | Other | Correlative studies |
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| Pharmacological Study | Other | Correlative studies |
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| Placebo | Other | Given PO |
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This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study.
| 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. | 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. | 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. | at Baseline and up to Day 35 |
| 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. | 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. | 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 | 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. | 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 | 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. | 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. | Up to day Day 35 |
| Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | up to Day 35 |
| Baltimore |
| Maryland |
| 21231 |
| United States |
| Johns Hopkins University/Sidney Kimmel Cancer Center | Baltimore | Maryland | 21287 | United States |
| Lahey Hospital and Medical Center | Burlington | Massachusetts | 01805 | United States |
| Minneapolis Veterans Medical Center | Minneapolis | Minnesota | 55417 | United States |
| University of Minnesota Medical Center-Fairview | Minneapolis | Minnesota | 55455 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Carolina Urologic Research Center | Myrtle Beach | South Carolina | 29572 | United States |
| Urology San Antonio Research PA | San Antonio | Texas | 78229 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Cholecalciferol: Given PO Genistein: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm II (Placebo) | Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO |
| BG001 | Arm I (Cholecalciferol, Genistein) | Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Cholecalciferol: Given PO Genistein: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | ng/mL | up to Day 35 |
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| Secondary | 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 | Due to sample one participant in Arm 1 was not analyzed for this Outcome. | Posted | Mean | Standard Deviation | ng/mL | Baseline and up to day 35 |
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| Primary | 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 | Posted | Number | participants | up to 35 days |
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| Secondary | 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. | Due to sample one participant in Arm 1 was not analyzed for this Outcome. | Posted | Mean | Standard Deviation | ng/mL | baseline and Up to Day 35 |
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| Secondary | PBMC CYP mRNA Expression of CYP24 | This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein. | Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome. | Posted | Geometric Mean | Standard Deviation | Ratio to Baseline | Baseline and Up to Day 35 |
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| Secondary | PBMC CYP mRNA Expression of CYP27B1 | This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein. | Posted | Geometric Mean | Standard Deviation | Ratio to Baseline | Up to Day 35 |
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| Secondary | 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. | Due to sample one participant in Arm I was not analyzed for this Outcome. | Posted | Median | Standard Deviation | ng/mL | at Baseline and up to Day 35 |
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| Secondary | 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. | Due to sample one participant in Arm I was not analyzed for this Outcome. | Posted | Mean | Standard Deviation | ng/mL (absolute change) | Baseline and Day 35 |
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| Secondary | 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. | Due to sample one participant in Arm I was not analyzed for this Outcome. | Posted | Mean | Standard Deviation | ng/mL | Baseline and up to Day 35 |
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| Secondary | 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 | Due to sample one participant in Arm 1 was not analyzed. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Up to Day 35 |
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| Secondary | 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. | Due to sample one participant from Arm 1 was not analyzed. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Up to Day 35 |
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| Secondary | 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 | Due to sample one participant in Arm I was not analyzed. | Posted | Mean | Standard Deviation | ng/mL | Baseline and Up to Day 35 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Normalized Optical Density | Up to Day 35 |
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| Secondary | 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. | Due to sample in Arm II one participants data was not analyzed. | Posted | Mean | Standard Deviation | Normalized Optical Density | Up to day Day 35 |
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| Secondary | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | Posted | Number | percentage of participants | up to Day 35 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm II (Placebo) | Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies Placebo: Given PO | 0 | 8 | 4 | 8 | ||
| EG001 | Arm I (Cholecalciferol, Genistein) | Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy. Cholecalciferol: Given PO Genistein: Given PO Laboratory Biomarker Analysis: Correlative studies Pharmacological Study: Correlative studies | 0 | 7 | 5 | 7 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperthyriodism | Endocrine disorders | CTCAE (4.0) | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| fatigue | General disorders | CTCAE (4.0) | Systematic Assessment |
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| pain | General disorders | CTCAE (4.0) | Systematic Assessment |
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| sinusitis | Infections and infestations | CTCAE (4.0) | Systematic Assessment |
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| blood bilirubin increased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| increased serum chloride | Investigations | CTCAE (4.0) | Systematic Assessment |
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| platelet count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| hypophosphatemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
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| sinus pain | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| allergic rhinitis | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| calcified lung nodule-right ct scan | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
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| hypertension | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Howard H. Bailey | University of Wisconsin | 608-263-8624 | hhbailey@wisc.edu |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D019833 | Genistein |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D007529 | Isoflavones |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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