Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cholecalciferol
placebo
Sponsored by
About this trial
This is an interventional basic science trial for Prostate Cancer focused on measuring prostate cancer, vitamin D
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of prostate cancer (by prostate biopsy)
- Scheduled to undergo a prostatectomy
- Ability to give his own consent to participate in the study
Exclusion Criteria:
- Serum 25(OH)D level less than 8ng/ml or greater than 50 ng/ml
- Vitamin D3 supplementation greater than or equal to 1000 IU daily
Sites / Locations
- Ralph H. Johnson VA Medical Center
- MUSC (Medical University of South Carolina)
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Intervention: Cholecalciferol
Placebo
Arm Description
vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
Outcomes
Primary Outcome Measures
Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
Baseline vitamin D3 levels will be obtained at enrollment and approximately two months later during the surgical procedure (prostatectomy). These D3 levels will be evaluated for the 27 participants who had genomic analysis and compared by race (Caucasian and AA).
Secondary Outcome Measures
Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants
The intent of this outcome measure was to identify the number of gene transcripts found to be differentially expressed (where a difference or change has occurred) in both AA and EA subjects upon vitamin D supplementation. The transcripts differentially expressed were compared to the transcripts in the "Placebo" Arm/Group.
Full Information
NCT ID
NCT02726113
First Posted
December 6, 2011
Last Updated
December 2, 2019
Sponsor
Medical University of South Carolina
1. Study Identification
Unique Protocol Identification Number
NCT02726113
Brief Title
Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
Official Title
Vitamin D and Prostate Cancer: A Randomized Clinical Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of South Carolina
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study population will be 80 adult men who have been diagnosed with prostate cancer who are scheduled to have their prostate surgically removed at either the Medical University of South Carolina (MUSC) or the Ralph H. Johnson VAMC, both located in Charleston, SC. The men will be randomized into two groups: one group will take vitamin D3 supplementation and the other will take a placebo. Blood levels of vitamin D3 will be obtained at the beginning of the study and again after two months, just prior to the surgical procedure (prostatectomy). Prostate tissue will be obtained from the surgical procedure and studied for the effect of vitamin D on the prostate cancer cells.
Detailed Description
This study will enroll 80 (40 per study arm) subjects (>18 years of age), recently diagnosed with prostate cancer (histologically documented adenocarcinoma of the prostate), who are scheduled to undergo prostatectomy.
Eligible subjects will be recruited in the Urology Clinic at MUSC or Ralph H. Johnson VAMC. All subjects will be refered to the study by their Urologist. At the baseline visit, consent will be obtained before any study procedures are initiated. A blood sample will be obtained for 25(OH)D3 analysis. Subjects will be randomized to either the intervention group (vitamin D3 4000 IU daily) or the placebo group and take the study medication for approximately two months before their scheduled prostatectomy. The final study visit is the day of surgery. A blood sample for 25(OH)D3 analysis will be obtained. Prostate tissue will be collected from the Pathologist for (a) genomics (RNA sequencing) analysis; (b) proteomics (proteins, glycons and lipids) analysis and (c) Vitamin D Receptor (VDR) by immunohistochemistry.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer, vitamin D
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention: Cholecalciferol
Arm Type
Active Comparator
Arm Description
vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).
Intervention Type
Drug
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
vitamin D3
Intervention Description
softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy).
Primary Outcome Measure Information:
Title
Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
Description
Baseline vitamin D3 levels will be obtained at enrollment and approximately two months later during the surgical procedure (prostatectomy). These D3 levels will be evaluated for the 27 participants who had genomic analysis and compared by race (Caucasian and AA).
Time Frame
approximately two months from baseline to date of prostatectomy (exit)
Secondary Outcome Measure Information:
Title
Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants
Description
The intent of this outcome measure was to identify the number of gene transcripts found to be differentially expressed (where a difference or change has occurred) in both AA and EA subjects upon vitamin D supplementation. The transcripts differentially expressed were compared to the transcripts in the "Placebo" Arm/Group.
Time Frame
up to 8 months post prostatectomy
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of prostate cancer (by prostate biopsy)
Scheduled to undergo a prostatectomy
Ability to give his own consent to participate in the study
Exclusion Criteria:
Serum 25(OH)D level less than 8ng/ml or greater than 50 ng/ml
Vitamin D3 supplementation greater than or equal to 1000 IU daily
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastiano Gattoni-Celli, MD
Organizational Affiliation
MUSC Department of Radiation Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ralph H. Johnson VA Medical Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29401
Country
United States
Facility Name
MUSC (Medical University of South Carolina)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
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