Prostate Cancer
Conditions
Keywords
prostate cancer, vitamin D
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.
Interventions
DRUGcholecalciferol
softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).
OTHERplacebo
softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy).
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
19 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | approximately two months from baseline to date of prostatectomy (exit) | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants | up to 8 months post prostatectomy | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects with diagnosed prostate cancer, who were scheduled for prostatectomy, were randomized into D3 supplementation vs Placebo groups prior to surgey
Pre-assignment details
Overall Study
Participants by arm
| Arm | Count |
|---|---|
| Intervention vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy). | 28 |
| Placebo softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy). | 22 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Genomic Analysis | Insurance non-coverage for surgery | 1 | 1 |
| Genomic Analysis | Protocol Violation | 1 | 0 |
| Genomic Analysis | Withdrawal by Subject | 2 | 1 |
| Total Enrollment | Insurance non-coverage for surgery | 1 | 1 |
| Total Enrollment | Physician Decision | 0 | 1 |
| Total Enrollment | Protocol Violation | 1 | 0 |
| Total Enrollment | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Intervention | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 5 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 17 Participants | 34 Participants |
| Race/Ethnicity, Customized African American | 10 participants | 10 participants | 20 participants |
| Race/Ethnicity, Customized Caucasian/Non-Hispanic | 18 participants | 12 participants | 30 participants |
| Region of Enrollment United States | 28 participants | 22 participants | 50 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 28 Participants | 22 Participants | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 28 | 0 / 22 |
| serious Total, serious adverse events | 0 / 28 | 0 / 22 |
Outcome results
Primary
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).
Time frame: approximately two months from baseline to date of prostatectomy (exit)
Population: 27 participants, who had genomic analysis (RNA sequencing), were evlauated for their serum level of D3 at baseline and exit. Intervention: 9 Caucasian/5 AA and Control: 8 Caucasian/5 AA
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Baseline Caucasian | 29.8 ng/ml |
| Intervention | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Exit Caucasian | 46.94 ng/ml |
| Intervention | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Baseline AA | 21.66 ng/ml |
| Intervention | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Exit AA | 48.84 ng/ml |
| Control | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Exit AA | 24.88 ng/ml |
| Control | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Baseline Caucasian | 34.8 ng/ml |
| Control | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Baseline AA | 26.06 ng/ml |
| Control | Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo). | Exit Caucasian | 29.6 ng/ml |
Secondary
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.
Time frame: up to 8 months post prostatectomy
Population: All study participants completed genomic analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention | Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants | 346 differentially expressed transcripts |