Clinical trial NCT04621500: Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans
Official title: Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Vitamin D Deficiency
Stress Reaction
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Ralph H. Johnson VA Medical Center
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2020-11-09
Enrollment: 36
Sex: MALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single, open-label group
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Detailed 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.

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

Primary outcomes:
measure: Change in transcriptional profiles after vitamin D supplementation.
timeFrame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Secondary outcomes:
measure: Histopathology changes in the Gleason Score on repeat biopsy findings after vitamin D supplementation
timeFrame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
measure: Histopathology changes in the number of positive cores on repeat biopsy findings after vitamin D supplementation.
timeFrame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
measure: Histopathology changes in the highest percentage of core involvement on repeat biopsy findings after vitamin D supplementation.
timeFrame: Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
measure: Identify changes in molecular signature that exist in AA and Caucasian men in relation to vitamin D levels
timeFrame: Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
Study officials:
affiliation: MUSC Psychiatry and Behavioral Sciences
name: Chanita Hughes-Halbert, PhD
role: STUDY_DIRECTOR
References: