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| ID | Type | Description | Link |
|---|---|---|---|
| 5U54MD010706-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Ralph H. Johnson VA Medical Center | FED |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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Veterans between the ages of 50-75, who are having a prostate biopsy, will be recruited for their permission to collect an extra biopsy core for RNA-sequencing. If the participants' treatment decision is Active Surveillance, they will be enrolled into the intervention phase of the study. They will receive supplementation with Vitamin D3 (4,000 IU) daily with repeat (surveillance) prostate biopsy one year later. At that time an extra prostate sample core will be collected for RNA-sequencing to determine changes over time. Measurements for allostatic load (body stress/inflammatory markers) will also be collected at the time of enrollment and at the repeat prostate biopsy visit.
This is an open-label pilot study. The goal is to investigate the transcription and biological pathways in prostate cancer that are especially relevant to prostate cancer disparities between African American and Caucasian men. Also, to determine any significant differences in the molecular signature that exist in African American and Caucasian men in relation to their Vitamin D levels.
Recruitment will be at the Urology Clinic at the Ralph H. Johnson VA Medical Center in Charleston, SC. Men who are scheduled for a Standard of Care prostate biopsy will be consented for their permission to collect an extra prostate tissue core for RNA-sequencing.
After the pathology report is discussed by their Urologist, and the treatment decision is Active Surveillance, the participant is enrolled into the Intervention Phase. At that time, baseline allostatic load measurements (Blood pressure, pulse, waist/hip ratio, height, and weight for BMI) and bloodwork: (lipid panel, HgbA1c, albumin and creatinine, IL-6, CRP, and DHEA-s (inflammatory markers) plus a Vitamin D level, will be collected. Vitamin D3 soft gels (4,000 IU) daily (six months' supply) will be dispensed. A Social Determinants survey will also be dispensed for subject completion.
At the Urology Standard of Care six-month follow-up appointment, the vitamin D serum level will be collected and the next six months' supply of vitamin D3 will be dispensed.
At the Urology Standard of Care follow-up (repeat at 1 year) surveillance prostate biopsy, an extra prostate tissue core will be collected for RNA-sequencing. The allostatic load measurements and bloodwork will also be obtained.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label | Other | All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Drug | Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation. | RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men. | Scheduled prostate biopsy at baseline and repeat biopsy after 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Median Percentage of Positive Cores at 1-year Post-baseline | During a routine prostate biopsy, 12 core samples are collected: 2 samples from the top right, front and back, 2 from the top left, front and back; 2 from the middle right and 2 from the middle left; 2 from the bottom right and 2 from the bottom left. When the 12 cores are examined under the microscope, the Pathologist identifies which cores contain cancer cells (or are positive for cancer). Therefore, the pathology report will identify the number of positive cores between 0 to 12. Changes to the baseline and repeat prostate biopsy positive core will be analyzed. |
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Inclusion Criteria:
Recruitment:
Enrollment:
Exclusion Criteria:
Individuals having a prostate biopsy are eligible for recruitment.
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| Name | Affiliation | Role |
|---|---|---|
| Chanita Hughes-Halbert, PhD | MUSC Psychiatry and Behavioral Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States |
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Patients were recruited in the urology clinic at the Ralph H. Johnson VAMC. All patients who were eligible for active surveillance for prostate cancer were offered enrollment and were followed at the same location. They were recruited from 6/4/19 until 2/4/22
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| ID | Title | Description |
|---|---|---|
| FG000 | Open Label | All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq: RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation: Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 20, 2022 |
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Single, open-label group
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| Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq | Procedure | RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men and (b) compare Allostatic Load results to determine stress response and (c) identify changes in the molecular signature in relation to vitamin D levels |
|
| Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation | Procedure | Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%). |
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| Allostatic Load | Diagnostic Test | Diagnostic Test: Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation Allostatic Load measurements to determine body stress compared at baseline and after one year of vitamin D3 supplementation. Also compared with RNA-seq results to determine stress response. Other Names: Bloodwork for HgbA1c, lipid profile, creatinine, albumin and vitamin D levels. Body measurements: Ht. Wt, BMI, waist and hip measurements for waist/hip ratio. Measurements of systolic and diastolic blood pressure and heart rate |
|
| Scheduled prostate biopsy at baseline and repeat biopsy after 1 year |
| Identify Changes in Molecular Signature That Exist in AA and Caucasian Men in Relation to Vitamin D Levels | RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response | Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Open Label | All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq: RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men and (b) compare Allostatic Load results to determine stress response and (c) identify changes in the molecular signature in relation to vitamin D levels Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation: Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%). |
| Units | Counts |
|---|---|
| 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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| Sex: Female, Male | All males | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Age (years) | Median | Inter-Quartile Range | years |
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| Body Mass Index (BMI) | Measured in kilograms per meters squared | Median | Full Range | Measured in kilograms per meters squared |
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| Vitamin D (ng/ml) | Measured in nanograms per milliliter | Median | Full Range | nanograms per milliliter |
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| Total cholesterol (mg/dl) | Measured in milligrams per deciliter | Median | Full Range | milligrams per deciliter |
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| HbA1c level% | Median | Full Range | Percentage |
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| psa (mcg/l) | Measured in micrograms per liter | Median | Full Range | micrograms per liter |
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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 | Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation. | RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men. | We analyzed all subjects and compared initial biopsy results and RNA sequencing information at baseline and after supplemental vitamin D3 one year later. We looked at modifications of signaling pathways from baseline and after treatment and also compared African-Americans vs. Caucasions | Posted | Number | percentage of subjects | Scheduled prostate biopsy at baseline and repeat biopsy after 1 year |
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| Secondary | Median Percentage of Positive Cores at 1-year Post-baseline | During a routine prostate biopsy, 12 core samples are collected: 2 samples from the top right, front and back, 2 from the top left, front and back; 2 from the middle right and 2 from the middle left; 2 from the bottom right and 2 from the bottom left. When the 12 cores are examined under the microscope, the Pathologist identifies which cores contain cancer cells (or are positive for cancer). Therefore, the pathology report will identify the number of positive cores between 0 to 12. Changes to the baseline and repeat prostate biopsy positive core will be analyzed. | Posted | Median | Full Range | percentage of positive cores | Scheduled prostate biopsy at baseline and repeat biopsy after 1 year |
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| Secondary | Identify Changes in Molecular Signature That Exist in AA and Caucasian Men in Relation to Vitamin D Levels | RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response | Number of positive cores per patient on a standard prostate biopsy involving systematic sampling of the prostate. | Posted | Mean | 99% Confidence Interval | number of positive cores | Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits |
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throughout the study, up to 2 years and 8 months
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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 | Open Label | All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. cholecalciferol: Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq: RNA-seq analysis will be used to (a) identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men and (b) compare Allostatic Load results to determine stress response and (c) identify changes in the molecular signature in relation to vitamin D levels Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation: Pathology results of the prostate biopsies will be analyzed for changes in the (a) Gleason Score (b) the number of positive cores (0 to 12) and (c) the highest percentage of positive core involvement (0 to 100%). | 0 | 60 | 0 | 60 | 0 | 60 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen J. Savage, MD | Medical University of South Carolina | 18437925787 | savages@musc.edu |
| Mar 17, 2024 |
| Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 20, 2022 | Dec 15, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014808 | Vitamin D Deficiency |
| D015775 | Fractures, Stress |
| 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 |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| D000081246 | RNA-Seq |
| D052636 | Allostasis |
| 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 |
| D020869 | Gene Expression Profiling |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
| D059014 | High-Throughput Nucleotide Sequencing |
| D017421 | Sequence Analysis |
| D017423 | Sequence Analysis, RNA |
| D000222 | Adaptation, Physiological |
| D000220 | Adaptation, Biological |
| D001686 | Biological Phenomena |
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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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