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

• Status: Recruiting
• Trial end date: 2022-06-30
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Medical University of South Carolina
• Collaborators: City of Hope Comprehensive Cancer Center; MUSC Psychiatry and Behavioral Sciences; Ralph H. Johnson VA Medical Center
• Treatments: Cholecalciferol; Vitamin D

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