A Phase 2 interventional study of cholecalciferol and Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq in Prostate Cancer, Vitamin D Deficiency and Stress Reaction, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to male participants aged 50 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-07-04.
Sponsored by Medical University of South Carolina · Phase 2, Interventional, and Basic science
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 60 is close to the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
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Recruitment:
Enrollment:
Exclusion Criteria:
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
Drug: cholecalciferol · Procedure: Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq · Procedure: Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation · Diagnostic Test: Allostatic Load
Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year
Also known as: vitamin D3
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
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%).
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
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.
Time frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
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.
Time frame: 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
Time frame: Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits
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
| Milestone | Open Label |
|---|---|
| Started | 60 |
| Completed | 60 |
| Not completed | 0 |
RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
| percentage of subjects | Open Label |
|---|---|
| Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation. | 100 |
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.
| percentage of positive cores | Open Label |
|---|---|
| Median Percentage of Positive Cores at 1-year Post-baseline | 0.5 (0 to 5) |
RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response
| number of positive cores | Open Label |
|---|---|
| Identify Changes in Molecular Signature That Exist in AA and Caucasian Men in Relation to Vitamin D Levels | 17.4 (16.336 to 18.464) |
Collected over throughout the study, up to 2 years and 8 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Open Label | 0/60 (0%) | 0/60 (0%) | 0/60 (0%) |
| Age, Categorical(Participants) | Open Label |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 29 |
| >=65 years | 31 |
| Sex: Female, Male(Participants) | Open Label |
|---|---|
| Female | 0 |
| Male | 60 |
| Race (NIH/OMB)(Participants) | Open Label |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 33 |
| White | 27 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Open Label |
|---|---|
| United States | 60 |
| Age (years)(years) | Open Label |
|---|---|
| Median | 65 (46 to 76) |
| Body Mass Index (BMI)(Measured in kilograms per meters squared) | Open Label |
|---|---|
| Median | 29.2 (17.8 to 52.1) |
| Vitamin D (ng/ml)(nanograms per milliliter) | Open Label |
|---|---|
| Median | 28 (4.8 to 68.6) |
| Total cholesterol (mg/dl)(milligrams per deciliter) | Open Label |
|---|---|
| Median | 189 (85 to 271) |
2 further baseline measures are reported on the registry.
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