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

NCT ID: NCT02726113

Last Updated: 2019-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-12-31

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.

Detailed 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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

Intervention: Cholecalciferol

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

Group Type: ACTIVE_COMPARATOR

cholecalciferol

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: OTHER

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

Interventions

cholecalciferol

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

Intervention Type: DRUG

placebo

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

Intervention Type: OTHER

Other Intervention Names

vitamin D3

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sebastiano Gattoni-Celli, MD

Role: PRINCIPAL_INVESTIGATOR

MUSC Department of Radiation Oncology

Locations

Ralph H. Johnson VA Medical Center

Charleston, South Carolina, United States

MUSC (Medical University of South Carolina)

Charleston, South Carolina, United States

Countries

United States

Other Identifiers

MUSC Pro# 12772

Identifier Type: -

Identifier Source: org_study_id