Prostate Cancer Clinical Trial

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

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 wil 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) will also be collected at the time of enrollment and at the repeat prostate biopsy visit.

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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) 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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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

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT04621500

Recruitment Status:

Active, not recruiting

Sponsor:

Medical University of South Carolina

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There is 1 Location for this study

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Ralph H. Johnson VA Medical Center
Charleston South Carolina, 29401, United States

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 2

Estimated Enrollment:

60

Study ID:

NCT04621500

Recruitment Status:

Active, not recruiting

Sponsor:


Medical University of South Carolina

How clear is this clinincal trial information?

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