Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans

NCT ID: NCT04621500

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-04
• Study Completion Date: 2022-02-04

Brief 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. 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.

Conditions

Prostate Cancer; Vitamin D Deficiency; Stress Reaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Open label

All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.

Group Type: OTHER

cholecalciferol

Intervention Type: DRUG

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

Intervention Type: 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

Intervention Type: 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%).

Allostatic Load

Intervention Type: 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

Interventions

cholecalciferol

Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year

Intervention Type: DRUG

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

Intervention Type: PROCEDURE

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%).

Intervention Type: PROCEDURE

Allostatic Load

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

vitamin D3

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• current vitamin D3 supplementation > 2,000 IU daily
• inability or unwillingness to continue to participate in the study

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ralph H. Johnson VA Medical Center

FED

Sponsor Role: collaborator

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Chanita Hughes-Halbert, PhD

Role: STUDY_DIRECTOR

MUSC Psychiatry and Behavioral Sciences

Locations

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5U54MD010706-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

00085140

Identifier Type: -

Identifier Source: org_study_id