Prostate Adenocarcinoma, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage I Prostate Cancer
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGCholecalciferol
Given PO
DRUGGenistein
Given PO
OTHERLaboratory Biomarker Analysis
Correlative studies
OTHERPharmacological Study
Correlative studies
OTHERPlacebo
Given PO
Sponsors
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must have microscopic confirmation of adenocarcinoma of the prostate within three months of randomization; clinical stage T1 and T2 a, b, or c are allowed * Participants' prostate cancer must be confined to the prostate (in the clinical judgment of the treating physician) * Participants must be candidates for prostatectomy * Participants must have Eastern Cooperative Oncology Group (ECOG) performance status =\<1 (Karnofsky \>= 70%) * White blood cell (WBC) within normal limits * Platelets \>= 100 K/uL * Hemoglobin \>= 10 g/dL * Thyroid-stimulating hormone (TSH) =\< 4.20 uIU/mL * Free T4 =\< 12.5 ng/dL * Bilirubin within upper limit of normal * Aspartate aminotransferase (AST) =\< 1.5 x upper limit of normal * Creatinine =\< 2.0 mg/dL * Serum calcium: within institutional normal limits * Participants must agree to stop taking nonsteroidal anti-inflammatory drugs (NSAIDS) during the course of the study, however, low dose aspirin (\< 100 mg/day) will be allowed; no wash out period is required * Participants must be willing to discontinue consuming soy products and ingesting vitamin supplements while participating in this study * The effects of cholecalciferol and genistein on the developing human fetus at the recommended therapeutic doses are unknown; for this reason, participants must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation * Participants must have the ability to understand and sign a consent form indicating the investigational nature of the treatment and its potential risks
Exclusion criteria
* Participants may not have received any prior therapy for prostate cancer including: chemotherapy, hormonal therapy, brachytherapy, or external radiation * Participants may not be receiving concurrent systemic therapy for other cancers * Participants may not be receiving any other investigational agents * Participants may not be taking the following p450 inducers and inhibitors: carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole, phenobarbital, phenytoin, rifabutin, rifampin * Participants who took finasteride or dutasteride within 6 months of the pre-randomization biopsy, are currently taking finasteride or dutasteride, or are planning on taking these agents during study participation * Participants with a history of allergic reactions attributed to genistein or placebo, or compounds of similar chemical or biologic composition * Participants with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Participants requires thyroid replacement therapy; Note: participants with a history of thyroid disease \> 5 years ago, with current normal thyroid function, will be considered eligible * Participant has current, known nephrolithiasis or a history of nephrolithiasis within the past 5 years * Participant has any history of sarcoidosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms | up to Day 35 | This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein |
| Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | up to 35 days | To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PBMC CYP mRNA Expression of CYP24 | Baseline and Up to Day 35 | This is a measure of expression of CYP24 in comparing placebo to Cholecalciferol/genistein. |
| PBMC CYP mRNA Expression of CYP27B1 | Up to Day 35 | This is a measure of expression of CYP27B1 in comparing placebo to Cholecalciferol/genistein. |
| Total PSA in Serum | at Baseline and up to Day 35 | This is a measure of the concentration of PSA in the blood serum at baseline and at the end of study. |
| Serum Calcium Levels at Baseline and Pre-Surgery | Baseline and Day 35 | This is a measurement of calcium in the Blood serum at baseline and at the end of the study. |
| Total IGF-1 in Serum at Baseline and Pre-Surgery | Baseline and up to Day 35 | This is measuring the concentration of the Biomarker IGF-1 in blood serum at Baseline and at the end of the study. |
| Levels of Calcidiol in the Participants Serum | Baseline and up to day 35 | This is measuring the amount of Calcidiol that was found in the participants blood Serum at baseline and end of study |
| Total IGFBP-3 in Serum at Baseline and Pre-Surgery | Baseline and Up to Day 35 | This is measuring the concentration of the Biomarker IGFBP-3 in blood serum at Baseline and at the end of the study. |
| Total PTH in Serum at Baseline and Pre-Surgery | Baseline and Up to Day 35 | This is measuring the concentration of the Biomarker PTH in blood serum at Baseline and at the end of the study |
| Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Up to Day 35 | 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. |
| Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Up to day Day 35 | 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. |
| Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | up to Day 35 | — |
| Total IGF-2 in Serum at Baseline and Pre-Surgery | Baseline and Up to Day 35 | This is measuring the concentration of the Biomarker IGF-2 in blood serum at Baseline and at the end of the study |
| Levels of Calcitriol in Participants Serum | baseline and Up to Day 35 | This is measuring the amount of Calcitriol that was found in the participants blood Serum at baseline and end of study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 8 |
| 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 | 7 |
| Total | 15 |
Baseline characteristics
| Characteristic | Arm II (Placebo) | Arm I (Cholecalciferol, Genistein) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 5 Participants | 11 Participants |
| Age, Continuous | 60.75 years STANDARD_DEVIATION 4.5 | 62.14 years STANDARD_DEVIATION 4.26 | 61.40 years STANDARD_DEVIATION 4.29 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 7 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 7 Participants | 15 Participants |
| Region of Enrollment United States | 8 participants | 7 participants | 15 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 8 | 5 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 7 |
Outcome results
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
Time frame: up to 35 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm II (Placebo) | Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Undetectable | 7 participants |
| Arm II (Placebo) | Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Detectable | 1 participants |
| Arm I (Cholecalciferol, Genistein) | Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Undetectable | 6 participants |
| Arm I (Cholecalciferol, Genistein) | Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms | Detectable | 1 participants |
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
Time frame: up to Day 35
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms | 0.045 ng/mL | Standard Deviation 0.127 |
| Arm I (Cholecalciferol, Genistein) | Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms | 0.057 ng/mL | Standard Deviation 0.15 |
Comparison: Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.p-value: 0.922t-test, 2 sided
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.
Time frame: Up to Day 35
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | p21 (Nucleus) | -0.085 Normalized Optical Density | Standard Deviation 1.07 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | IGF-1 (Cytoplasm) | -0.295 Normalized Optical Density | Standard Deviation 0.607 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | TUNEL Pos (Nucleus) | -0.168 Normalized Optical Density | Standard Deviation 0.842 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | IGF-2 (Cytoplasm) | -0.335 Normalized Optical Density | Standard Deviation 0.763 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | VDR (Cytoplasm) | -0.451 Normalized Optical Density | Standard Deviation 0.41 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Akt (Nucleus) | -0.316 Normalized Optical Density | Standard Deviation 0.618 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Caspase 3 (Cytoplasm) | -0.308 Normalized Optical Density | Standard Deviation 0.659 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | pAkt (Nucleus) | -0.114 Normalized Optical Density | Standard Deviation 0.92 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | PGE2 (Cytoplasm) | -0.161 Normalized Optical Density | Standard Deviation 1.023 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Akt (Cytoplasm) | -0.249 Normalized Optical Density | Standard Deviation 0.766 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | PSMA (Cytoplasm) | 0.025 Normalized Optical Density | Standard Deviation 1.231 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | pAkt (Cytoplasm) | -0.053 Normalized Optical Density | Standard Deviation 1.004 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | AR (Nucleus) | -0.362 Normalized Optical Density | Standard Deviation 0.294 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | pAkt (Cytoplasm) | 0.061 Normalized Optical Density | Standard Deviation 0.991 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | AR (Nucleus) | 0.414 Normalized Optical Density | Standard Deviation 1.301 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | VDR (Cytoplasm) | 0.515 Normalized Optical Density | Standard Deviation 1.179 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | p21 (Nucleus) | 0.097 Normalized Optical Density | Standard Deviation 0.9 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | PGE2 (Cytoplasm) | 0.184 Normalized Optical Density | Standard Deviation 0.934 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | TUNEL Pos (Nucleus) | 0.192 Normalized Optical Density | Standard Deviation 1.122 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Caspase 3 (Cytoplasm) | 0.352 Normalized Optical Density | Standard Deviation 1.178 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | PSMA (Cytoplasm) | -0.029 Normalized Optical Density | Standard Deviation 0.63 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | IGF-1 (Cytoplasm) | 0.337 Normalized Optical Density | Standard Deviation 1.22 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | IGF-2 (Cytoplasm) | 0.383 Normalized Optical Density | Standard Deviation 1.081 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Akt (Nucleus) | 0.361 Normalized Optical Density | Standard Deviation 1.198 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | pAkt (Nucleus) | 0.131 Normalized Optical Density | Standard Deviation 1.068 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Benign Prostate Tissue (BPT) | Akt (Cytoplasm) | 0.284 Normalized Optical Density | Standard Deviation 1.142 |
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.
Time frame: Up to day Day 35
Population: Due to sample in Arm II one participants data was not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | PSMA (Cytoplasm) | -0.210 Normalized Optical Density | Standard Deviation 0.966 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | PGE2 (Cytoplasm) | -0.135 Normalized Optical Density | Standard Deviation 0.969 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | IGF-1 (Cytoplasm) | 0.155 Normalized Optical Density | Standard Deviation 1.027 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | AR (Nucleus) | -0.563 Normalized Optical Density | Standard Deviation 0.481 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | IGF-2 (Cytoplasm) | 0.443 Normalized Optical Density | Standard Deviation 1.102 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Akt (Nucleus) | -0.309 Normalized Optical Density | Standard Deviation 0.903 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | TUNEL Pos (Nucleus) | -0.363 Normalized Optical Density | Standard Deviation 0.664 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | pAkt (Nucleus) | -0.291 Normalized Optical Density | Standard Deviation 0.325 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | p21 (Nucleus) | -0.185 Normalized Optical Density | Standard Deviation 0.489 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Akt (Cytoplasm) | -0.379 Normalized Optical Density | Standard Deviation 0.785 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Caspase 3 (Cytoplasm) | -0.103 Normalized Optical Density | Standard Deviation 0.742 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | pAkt (Cytoplasm) | -0.365 Normalized Optical Density | Standard Deviation 0.377 |
| Arm II (Placebo) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | VDR (Cytoplasm) | -0.281 Normalized Optical Density | Standard Deviation 0.657 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | pAkt (Cytoplasm) | 0.365 Normalized Optical Density | Standard Deviation 1.244 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | AR (Nucleus) | 0.563 Normalized Optical Density | Standard Deviation 1.015 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | VDR (Cytoplasm) | 0.281 Normalized Optical Density | Standard Deviation 1.177 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | p21 (Nucleus) | 0.185 Normalized Optical Density | Standard Deviation 1.296 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | PGE2 (Cytoplasm) | 0.135 Normalized Optical Density | Standard Deviation 1.009 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | TUNEL Pos (Nucleus) | 0.363 Normalized Optical Density | Standard Deviation 1.119 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Caspase 3 (Cytoplasm) | 0.103 Normalized Optical Density | Standard Deviation 1.194 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | PSMA (Cytoplasm) | 0.210 Normalized Optical Density | Standard Deviation 0.982 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | IGF-1 (Cytoplasm) | -0.155 Normalized Optical Density | Standard Deviation 0.943 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Akt (Nucleus) | 0.309 Normalized Optical Density | Standard Deviation 0.981 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | pAkt (Nucleus) | 0.291 Normalized Optical Density | Standard Deviation 1.302 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | Akt (Cytoplasm) | 0.379 Normalized Optical Density | Standard Deviation 1.024 |
| Arm I (Cholecalciferol, Genistein) | Immunohistochemistry Measurements in Prostate Cancer Tissue (PCA) | IGF-2 (Cytoplasm) | -0.443 Normalized Optical Density | Standard Deviation 0.572 |
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
Time frame: Baseline and up to day 35
Population: Due to sample one participant in Arm 1 was not analyzed for this Outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Levels of Calcidiol in the Participants Serum | Baseline | 20.5 ng/mL | Standard Deviation 5.5 |
| Arm II (Placebo) | Levels of Calcidiol in the Participants Serum | Pre-Surgery | 19.2 ng/mL | Standard Deviation 5.1 |
| Arm I (Cholecalciferol, Genistein) | Levels of Calcidiol in the Participants Serum | Baseline | 24.5 ng/mL | Standard Deviation 9.3 |
| Arm I (Cholecalciferol, Genistein) | Levels of Calcidiol in the Participants Serum | Pre-Surgery | 27.3 ng/mL | Standard Deviation 10 |
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.
Time frame: baseline and Up to Day 35
Population: Due to sample one participant in Arm 1 was not analyzed for this Outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Levels of Calcitriol in Participants Serum | Baseline | 0.5 ng/mL | Standard Deviation 0.1 |
| Arm II (Placebo) | Levels of Calcitriol in Participants Serum | Pre-Surgery | 0.5 ng/mL | Standard Deviation 0.7 |
| Arm I (Cholecalciferol, Genistein) | Levels of Calcitriol in Participants Serum | Baseline | 0.5 ng/mL | Standard Deviation 0.2 |
| Arm I (Cholecalciferol, Genistein) | Levels of Calcitriol in Participants Serum | Pre-Surgery | 0.1 ng/mL | Standard Deviation 0.4 |
Secondary
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
Population: Due to sample two participant in Arm I and 2 participants in Arm II were not analyzed for this Outcome.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | PBMC CYP mRNA Expression of CYP24 | 3.054 Ratio to Baseline | Standard Deviation 3.997 |
| Arm I (Cholecalciferol, Genistein) | PBMC CYP mRNA Expression of CYP24 | 2.202 Ratio to Baseline | Standard Deviation 4.071 |
Secondary
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
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Arm II (Placebo) | PBMC CYP mRNA Expression of CYP27B1 | 1.656 Ratio to Baseline | Standard Deviation 2.628 |
| Arm I (Cholecalciferol, Genistein) | PBMC CYP mRNA Expression of CYP27B1 | 2.389 Ratio to Baseline | Standard Deviation 3.511 |
Secondary
Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene)
Time frame: up to Day 35
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2762939- C/G | 37.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2296241- A/A | 37.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2762939- G/G | 62.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2248359- C/T | 37.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs927650- C/C | 0 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2209314- T/T | 62.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs927650- C/T | 50 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2248359- T/T | 25 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs927650- T/T | 50 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2296241- A/G | 35.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs703842- A/A | 50 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2209314- T/C | 37.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs703842- A/G | 37.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2296241- G/G | 25 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs703842- G/G | 12.5 percentage of participants |
| Arm II (Placebo) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2248359- C/C | 37.5 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs703842- G/G | 14.29 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2296241- A/A | 14.29 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2209314- T/C | 42.86 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2209314- T/T | 57.14 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2248359- C/C | 42.86 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2248359- C/T | 57.14 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2296241- A/G | 71.43 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2296241- G/G | 14.29 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2762939- C/G | 28.57 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2762939- G/G | 71.43 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs927650- C/C | 71.43 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs927650- C/T | 14.29 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs927650- T/T | 14.29 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs703842- A/A | 14.29 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs703842- A/G | 71.43 percentage of participants |
| Arm I (Cholecalciferol, Genistein) | Percent of Participants With CYP24 and CYP27B1 SNPs (DNA From Paxgene) | rs2248359- T/T | 0 percentage of participants |
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.
Time frame: Baseline and Day 35
Population: Due to sample one participant in Arm I was not analyzed for this Outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Serum Calcium Levels at Baseline and Pre-Surgery | Baseline | 10.5 ng/mL (absolute change) | Standard Deviation 0.4 |
| Arm II (Placebo) | Serum Calcium Levels at Baseline and Pre-Surgery | Day 35 | 10.8 ng/mL (absolute change) | Standard Deviation 0.9 |
| Arm I (Cholecalciferol, Genistein) | Serum Calcium Levels at Baseline and Pre-Surgery | Baseline | 11.3 ng/mL (absolute change) | Standard Deviation 1.8 |
| Arm I (Cholecalciferol, Genistein) | Serum Calcium Levels at Baseline and Pre-Surgery | Day 35 | 10.9 ng/mL (absolute change) | Standard Deviation 0.9 |
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.
Time frame: Baseline and up to Day 35
Population: Due to sample one participant in Arm I was not analyzed for this Outcome.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Total IGF-1 in Serum at Baseline and Pre-Surgery | Baseline | 64.2 ng/mL | Standard Deviation 11.5 |
| Arm II (Placebo) | Total IGF-1 in Serum at Baseline and Pre-Surgery | Day 35 | 60.6 ng/mL | Standard Deviation 17.9 |
| Arm I (Cholecalciferol, Genistein) | Total IGF-1 in Serum at Baseline and Pre-Surgery | Baseline | 66.3 ng/mL | Standard Deviation 12.8 |
| Arm I (Cholecalciferol, Genistein) | Total IGF-1 in Serum at Baseline and Pre-Surgery | Day 35 | 74.6 ng/mL | Standard Deviation 14 |
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
Time frame: Baseline and Up to Day 35
Population: Due to sample one participant in Arm 1 was not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Total IGF-2 in Serum at Baseline and Pre-Surgery | Baseline | 770.4 ng/mL | Standard Deviation 333.4 |
| Arm II (Placebo) | Total IGF-2 in Serum at Baseline and Pre-Surgery | Pre-Surgery | 605.0 ng/mL | Standard Deviation 175.4 |
| Arm I (Cholecalciferol, Genistein) | Total IGF-2 in Serum at Baseline and Pre-Surgery | Pre-Surgery | 858.8 ng/mL | Standard Deviation 112.7 |
| Arm I (Cholecalciferol, Genistein) | Total IGF-2 in Serum at Baseline and Pre-Surgery | Baseline | 805.9 ng/mL | Standard Deviation 193.5 |
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.
Time frame: Baseline and Up to Day 35
Population: Due to sample one participant from Arm 1 was not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Total IGFBP-3 in Serum at Baseline and Pre-Surgery | Day 35 | 1667.5 ng/mL | Standard Deviation 788.9 |
| Arm II (Placebo) | Total IGFBP-3 in Serum at Baseline and Pre-Surgery | Baseline | 1838.9 ng/mL | Standard Deviation 887.3 |
| Arm I (Cholecalciferol, Genistein) | Total IGFBP-3 in Serum at Baseline and Pre-Surgery | Day 35 | 1843.4 ng/mL | Standard Deviation 443.3 |
| Arm I (Cholecalciferol, Genistein) | Total IGFBP-3 in Serum at Baseline and Pre-Surgery | Baseline | 2004.5 ng/mL | Standard Deviation 309.8 |
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.
Time frame: at Baseline and up to Day 35
Population: Due to sample one participant in Arm I was not analyzed for this Outcome.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Total PSA in Serum | Baseline | 8.7 ng/mL | Standard Deviation 7.3 |
| Arm II (Placebo) | Total PSA in Serum | Day 35 | 8.3 ng/mL | Standard Deviation 6.7 |
| Arm I (Cholecalciferol, Genistein) | Total PSA in Serum | Baseline | 6.3 ng/mL | Standard Deviation 1.7 |
| Arm I (Cholecalciferol, Genistein) | Total PSA in Serum | Day 35 | 5.8 ng/mL | Standard Deviation 2.1 |
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
Time frame: Baseline and Up to Day 35
Population: Due to sample one participant in Arm I was not analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm II (Placebo) | Total PTH in Serum at Baseline and Pre-Surgery | Baseline | 143.4 ng/mL | Standard Deviation 26.5 |
| Arm II (Placebo) | Total PTH in Serum at Baseline and Pre-Surgery | Pre-Surgery | 151.1 ng/mL | Standard Deviation 25.8 |
| Arm I (Cholecalciferol, Genistein) | Total PTH in Serum at Baseline and Pre-Surgery | Baseline | 144.8 ng/mL | Standard Deviation 37.8 |
| Arm I (Cholecalciferol, Genistein) | Total PTH in Serum at Baseline and Pre-Surgery | Pre-Surgery | 136.5 ng/mL | Standard Deviation 72.9 |