Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans (VitD/RNA-seq)
Primary Purpose
Prostate Cancer, Vitamin D Deficiency, Stress Reaction
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer
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
Sites / Locations
- Ralph H. Johnson VA Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Open label
Arm Description
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
Outcomes
Primary Outcome Measures
Change in transcriptional profiles after vitamin D supplementation.
RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
Secondary Outcome Measures
Histopathology changes in the Gleason Score on repeat biopsy findings after vitamin D supplementation
The first reported finding in the pathology report is the Gleason Score. When the prostate sample is examined under the microscope, the Pathologist determines which type of cell is the most common and which type is the second most common. Each of these cell types is given a score from 1 to 5. Higher numbers mean more abnormal, aggressive cancer cells. Because the two most common types of cancer cells are identified, the Gleason Score is a combination of these two cell types. For example, the first most common cell type is a 3 and the second is reported as a 4, then the Gleason Score is 3+4, or 7.
Changes to the baseline and repeat prostate biopsy Gleason Score will be analyzed.
Histopathology changes in the number of positive cores on repeat biopsy findings after vitamin D supplementation.
During a routine prostate biopsy, 12 core samples are collected: 2 samples from the top right, front and back, 2 from the top left, front and back; 2 from the middle right and 2 from the middle left; 2 from the bottom right and 2 from the bottom left. When the 12 cores are examined under the microscope, the Pathologist identifies which cores contain cancer cells (or are positive for cancer).
Therefore, the pathology report will identify the number of positive cores between 0 to 12.
Changes to the baseline and repeat prostate biopsy positive core will be analyzed.
Histopathology changes in the highest percentage of core involvement on repeat biopsy findings after vitamin D supplementation.
When the Pathologist examines the 12 core samples from the prostate biopsy, the percentage of cancer cells that are in each core is also identified. This can be from 0 to 100 percent involvement.
To facilitate the evaluation of the 12 percentages reported for the 12 cores in the pathology report, the Urology standard is to prioritize and assess the highest percentage of core involvement.
Changes to the baseline and repeat biopsy highest percentage core involvement will be analyzed.
Identify changes in molecular signature that exist in AA and Caucasian men in relation to vitamin D levels
RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response
Full Information
NCT ID
NCT04621500
First Posted
September 29, 2020
Last Updated
January 31, 2023
Sponsor
Medical University of South Carolina
Collaborators
Ralph H. Johnson VA Medical Center, National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT04621500
Brief Title
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans
Acronym
VitD/RNA-seq
Official Title
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Including Diversity and Stress Determinants, Among Veterans
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 4, 2019 (Actual)
Primary Completion Date
February 4, 2022 (Actual)
Study Completion Date
February 4, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina
Collaborators
Ralph H. Johnson VA Medical Center, National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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 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.
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) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Vitamin D Deficiency, Stress Reaction
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single, open-label group
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Open label
Arm Type
Other
Arm Description
All enrolled subjects will receive vitamin D3 at 4,000 IU daily for approximately one year.
Intervention Type
Drug
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vitamin D3
Intervention Description
Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year
Primary Outcome Measure Information:
Title
Change in transcriptional profiles after vitamin D supplementation.
Description
RNA-sequencing analysis will be utilized to identify changes in transcriptional profiles and biological pathways in the prostate between African American and Caucasian men.
Time Frame
Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Secondary Outcome Measure Information:
Title
Histopathology changes in the Gleason Score on repeat biopsy findings after vitamin D supplementation
Description
The first reported finding in the pathology report is the Gleason Score. When the prostate sample is examined under the microscope, the Pathologist determines which type of cell is the most common and which type is the second most common. Each of these cell types is given a score from 1 to 5. Higher numbers mean more abnormal, aggressive cancer cells. Because the two most common types of cancer cells are identified, the Gleason Score is a combination of these two cell types. For example, the first most common cell type is a 3 and the second is reported as a 4, then the Gleason Score is 3+4, or 7.
Changes to the baseline and repeat prostate biopsy Gleason Score will be analyzed.
Time Frame
Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Title
Histopathology changes in the number of positive cores on repeat biopsy findings after vitamin D supplementation.
Description
During a routine prostate biopsy, 12 core samples are collected: 2 samples from the top right, front and back, 2 from the top left, front and back; 2 from the middle right and 2 from the middle left; 2 from the bottom right and 2 from the bottom left. When the 12 cores are examined under the microscope, the Pathologist identifies which cores contain cancer cells (or are positive for cancer).
Therefore, the pathology report will identify the number of positive cores between 0 to 12.
Changes to the baseline and repeat prostate biopsy positive core will be analyzed.
Time Frame
Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Title
Histopathology changes in the highest percentage of core involvement on repeat biopsy findings after vitamin D supplementation.
Description
When the Pathologist examines the 12 core samples from the prostate biopsy, the percentage of cancer cells that are in each core is also identified. This can be from 0 to 100 percent involvement.
To facilitate the evaluation of the 12 percentages reported for the 12 cores in the pathology report, the Urology standard is to prioritize and assess the highest percentage of core involvement.
Changes to the baseline and repeat biopsy highest percentage core involvement will be analyzed.
Time Frame
Scheduled prostate biopsy at baseline and repeat biopsy after 1 year
Title
Identify changes in molecular signature that exist in AA and Caucasian men in relation to vitamin D levels
Description
RNA-seq analyses of prostate tissue plus allostatic load measurements to determine stress response
Time Frame
Scheduled prostate biopsies at baseline and after one year vit D supplementation plus allostatic load measurements at baseline and one yeat visits
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Individuals having a prostate biopsy are eligible for recruitment.
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chanita Hughes-Halbert, PhD
Organizational Affiliation
MUSC Psychiatry and Behavioral Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D Supplementation in RNA-seq Profiles of Single-core Prostate Samples, Among Veterans
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