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

Summary

Participation Requirements

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...

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) plus a vitamin D level, will be collected. Vitamin D3 softgels (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 a 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. A single blood vial will also be collected for ancestry markers.

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