Prostate CancerPhase 2VitD/RNA-seqNCT04621500
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans
A Phase 2 study testing cholecalciferol and Allostatic Load in people with Prostate Cancer and Vitamin D Deficiency, run by Medical University of South Carolina at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 75 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer, Vitamin D Deficiency, Stress Reaction
- What is being tested?
- cholecalciferol and Allostatic Load
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2019to 4 Feb 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Recruitment:
- scheduled for prostate biopsy
- permission for investigators to follow subject's post biopsy diagnosis, treatment decision and follow-up care (including subsequent prostate biopsies).
- Enrollment:
- diagnosis of prostate cancer
- treatment recommendation or subject decision of Active Surveillance
- agreement to supplement with vitamin D3 4,000 IU daily for approximately one year
- standard of care repeat PSA at six months and surveillance prostate biopsy at one year
Who cannot join
- current vitamin D3 supplementation > 2,000 IU daily
- inability or unwillingness to continue to participate in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Ralph H. Johnson VA Medical Center
Charleston, South Carolina, 29401
About this study
Official title: Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans
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.
Read the detailed description
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.
- Conditions
- Prostate Cancer, Vitamin D Deficiency, Stress Reaction
- Being tested
- cholecalciferol, Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq, Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation, Allostatic Load
- Medical subject headings
- Prostatic Neoplasms, Vitamin D Deficiency, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cholecalciferolDrug
Also called vitamin D3
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-seqProcedure or surgery
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 supplementationProcedure or surgery
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%).
Allostatic LoadDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| Open label | Other | All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Secondary outcomes (2)
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.
Measured: 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
Measured: Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2020
- Study start4 Jun 2019
- Primary completion4 Feb 2022
- Study completion4 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single, open-label group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- Ralph H. Johnson VA Medical Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Chanita Hughes-Halbert, PhD, Study director, MUSC Psychiatry and Behavioral Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04621500
- Sponsor's protocol ID
- 00085140
- Other IDs
- 5U54MD010706-03
- Acronym
- VitD/RNA-seq
- Status last verified
- Jul 2025
- First submitted
- 29 Sep 2020
- Last updated
- 4 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans
- ClinicalTrials.gov ID
- NCT04621500
- Acronym / sponsor ID
- VitD/RNA-seq / 00085140
- Conditions
- Prostate Cancer, Vitamin D Deficiency, Stress Reaction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- Ralph H. Johnson VA Medical Center, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 4 Jun 2019 (actual)
- Primary completion
- 4 Feb 2022 (actual)
- Study completion
- 4 Feb 2022 (actual)
- First posted
- 9 Nov 2020 (actual)
- Results
- Posted 4 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single, open-label group
| Arm | Type | Receives |
|---|---|---|
| Open label | Other | 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 LoadAll enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- scheduled for prostate biopsy
- permission for investigators to follow subject's post biopsy diagnosis, treatment decision and follow-up care (including subsequent prostate biopsies).
- diagnosis of prostate cancer
- treatment recommendation or subject decision of Active Surveillance
- agreement to supplement with vitamin D3 4,000 IU daily for approximately one year
Key exclusion criteria (2 listed)
- current vitamin D3 supplementation > 2,000 IU daily
- inability or unwillingness to continue to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cholecalciferolAlso: vitamin D3Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year | Drug | Open label |
| Standard of Care Prostate Biopsy - collection of 13th core for RNA-seqRNA-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 | Procedure or surgery | Open label |
| Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementationPathology 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%). | Procedure or surgery | Open label |
| Allostatic LoadDiagnostic 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 | Diagnostic test | Open label |
Primary outcome
Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation.
Time frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
2 secondary outcomes
Median Percentage of Positive Cores at 1-year Post-baseline
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
Time frame: Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Prostate Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
Active, not recruitingObservational study
MRI Fusion Biopsy vs. Micro-Ultrasound Guided Biopsy
Prostate Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chanita Hughes-Halbert, PhD study director
MUSC Psychiatry and Behavioral Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing cholecalciferol and Allostatic Load in people with Prostate Cancer and Vitamin D Deficiency, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation. (time frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2025.