Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 19 - 90 |
| Updated: | 4/21/2016 |
| Start Date: | October 2011 |
| End Date: | December 2015 |
Vitamin D and Prostate Cancer: A Randomized Clinical Study
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.
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.
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.
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
We found this trial at
2
sites
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