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

Prostate Cancer Clinical Trial

Official title:

Vitamin D and Prostate Cancer: A Randomized Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02726113
• Other study ID #: MUSC Pro# 12772
• Status: Completed
• Phase: Phase 2
• Start date: October 2011
• Est. completion date: December 2015

Study information

• Verified date: December 2019
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 19 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• cholecalciferol
softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).

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

Locations

Country	Name	City	State
United States	MUSC (Medical University of South Carolina)	Charleston	South Carolina
United States	Ralph H. Johnson VA Medical Center	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	approximately two months from baseline to date of prostatectomy (exit)
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.	up to 8 months post prostatectomy