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

Medical University of South Carolina (MUSC)

Status and phase

Completed

Phase 2

Conditions

Stress Reaction

Vitamin D Deficiency

Prostate Cancer

Treatments

Diagnostic Test: Allostatic Load Measurements at baseline and after one year vitamin D3 supplementation

Procedure: Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation

Procedure: Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq

Drug: cholecalciferol

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

NIH

Identifiers

NCT04621500

00085140

5U54MD010706-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

Male

Ages

50 to 75 years old

Volunteers

Accepts Healthy Volunteers

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