Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •current vitamin D3 supplementation > 2,000 IU daily
- •inability or unwillingness to continue to participate in the study
研究组 & 干预措施
Open label
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
干预措施: cholecalciferol (Drug)
Open label
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
干预措施: Standard of Care Prostate Biopsy - collection of 13th core for RNA-seq (Procedure)
Open label
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
干预措施: Standard of Care Prostate Biopsies at baseline and after one year vitamin D3 supplementation (Procedure)
Open label
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
干预措施: Allostatic Load (Diagnostic Test)
结局指标
主要结局
Percentage of Participants With Change in Transcriptional Profiles After Vitamin D Supplementation.
时间窗: 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.
次要结局
- Identify Changes in Molecular Signature That Exist in AA and Caucasian Men in Relation to Vitamin D Levels(Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits)
- Median Percentage of Positive Cores at 1-year Post-baseline(Scheduled prostate biopsy at baseline and repeat biopsy after 1 year)