Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Drug: cholecalciferol; Other: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02726113

MUSC Pro# 12772

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Male

Ages: 19 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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50 participants in 2 patient groups, including a placebo group

Intervention: Cholecalciferol

Active Comparator group

Description:

vitamin D3 (cholecalciferol) supplementation at 4000 IU daily for approximately two months prior to surgery (prostatectomy).

Treatment:

Drug: cholecalciferol

Placebo

Placebo Comparator group

Description:

softgel (containing no active ingredient) daily for approximately two months prior to surgery (prostatectomy).

Treatment:

Other: placebo