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NCT Number: NCT04621500

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

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Key information

Conditions

Prostate Cancer Avitaminosis Deficiency Diseases Fractures, Bone Fractures, Stress Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional and Metabolic Diseases Prostatic Diseases Prostatic Neoplasms Stress Reaction Urogenital Diseases Urogenital Neoplasms Vitamin D Deficiency Wounds and Injuries

Age range

50 year–75 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cholecalciferol

Drug

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

Other names: vitamin D3

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%).

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Median Percentage of Positive Cores at 1-year Post-baseline

    Time frame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year

    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.

  2. 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

    RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Ralph H. Johnson VA Medical Center

Registry information

Official study title

Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans

Acronym: VitD/RNA-seq

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 9, 2020
Registry last updated
Jul 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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