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

NCT02726113 | Completed Phase 2 Results

• 1 other identifier: MUSC Pro# 12772
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; vitamin D

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants

  up to 8 months post prostatectomy

Study Arms (2)

Intervention: Cholecalciferol

ACTIVE COMPARATOR

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

Drug: cholecalciferol

Placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

cholecalciferol DRUG

softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).

Also known as: vitamin D3

Intervention: Cholecalciferol

placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 19 Years - 90 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of prostate cancer (by prostate biopsy)
• Scheduled to undergo a prostatectomy
• Ability to give his own consent to participate in the study

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (2)

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, 29401, United States

Location

MUSC (Medical University of South Carolina)

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Sebastiano Gattoni-Celli, M.D.; Professor of Radiation Oncology
• Organization: Medical University of South Carolina

gattonis@musc.edu

843-876-5103

Study Officials

• Sebastiano Gattoni-Celli, MD

  MUSC Department of Radiation Oncology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2011
• First Posted: April 1, 2016
• Study Start: October 1, 2011
• Primary Completion: March 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 3, 2019
• Results First Posted: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)