Clinical trial NCT02726113: Vitamin D and Prostate Cancer: A Clinical Study Enrolling Subjects Undergoing Prostatectomy
Official title: Vitamin D and Prostate Cancer: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostate Cancer
Keywords: prostate cancer
vitamin D
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2016-04-01
Enrollment: 50
Sex: MALE
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Changes in Serum Levels of Vitamin D [25(OH)D3] in Subjects in the Supplementation Group and Those in the Control Group (Placebo).
timeFrame: approximately two months from baseline to date of prostatectomy (exit)
Secondary outcomes:
measure: Number of Gene Transcripts Identified Regulated by Vitamin D Supplementation in Both AA and European American Participants
timeFrame: up to 8 months post prostatectomy
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Ralph H. Johnson VA Medical Center
state: South Carolina
city: Charleston
country: United States
facility: MUSC (Medical University of South Carolina)
state: South Carolina
Study officials:
affiliation: MUSC Department of Radiation Oncology
name: Sebastiano Gattoni-Celli, MD
role: PRINCIPAL_INVESTIGATOR
References: