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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention: Cholecalciferol | Active Comparator | vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy). |
|
| Placebo | Placebo Comparator | softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cholecalciferol | Drug | softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | approximately two months from baseline to date of prostatectomy (exit) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sebastiano Gattoni-Celli, MD | MUSC Department of Radiation Oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ralph H. Johnson VA Medical Center | Charleston | South Carolina | 29401 | United States | ||
| MUSC (Medical University of South Carolina) |
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Overall Study
Subjects with diagnosed prostate cancer, who were scheduled for prostatectomy, were randomized into D3 supplementation vs Placebo groups prior to surgey
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy). |
| FG001 | Placebo | softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Total Enrollment |
|
| |||||||||||||||||||||
| Genomic Analysis |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy). |
| BG001 | Placebo | softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | 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 | Posted | Mean | Full Range | ng/ml | approximately two months from baseline to date of prostatectomy (exit) |
|
two months, or the period of each subject's participation
Each participant was questionned by a study team member whether he had experienced any adverse or unanticipated events from time of enrollment to just prior to his prostatectomy. Each participant's health record was reviewed from date of enrollment to date of prostatectomy (exit).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sebastiano Gattoni-Celli, M.D.; Professor of Radiation Oncology | Medical University of South Carolina | 843-876-5103 | gattonis@musc.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D002782 | Cholestenes |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
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| placebo | Other | softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy). |
|
| up to 8 months post prostatectomy |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| Withdrawal by Subject |
|
| Insurance non-coverage for surgery |
|
| NOT COMPLETED |
|
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Control | Placebo softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy). |
|
|
| 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. | All study participants completed genomic analysis | Posted | Number | differentially expressed transcripts | up to 8 months post prostatectomy | Total transcripts | Total transcripts |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| EG001 | Placebo | softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy). | 0 | 22 | 0 | 22 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D011083 |
| Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |