Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer (vit D & PCa)

• ClinicalTrials.gov Identifier: NCT00953225
• Recruitment Status: Completed
• First Posted: August 6, 2009
• Results First Posted: April 6, 2015
• Last Update Posted: October 9, 2017
• Sponsor: VA Office of Research and Development
• Collaborator: Medical University of South Carolina
• Information provided by (Responsible Party): VA Office of Research and Development

Study Description

Brief Summary:

Vitamin D promotes the differentiation of prostate cancer cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical prostate cancer to clinical disease. The investigators propose to conduct a clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with low-risk, early-stage prostate cancer, who elect to have their disease monitored through active surveillance. The successful completion of this proposed clinical study will allow us to determine whether correcting vitamin D deficiency in Veterans diagnosed with early-stage prostate cancer will prevent progression of their disease and improve their prognosis.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Drug: vitamin D3; Drug: Placebo daily for one year	Phase 2

Detailed Description:

Vitamin D promotes the differentiation of prostate cancer (PCa) cells, maintains the differentiated phenotype of prostate epithelial cells, and can induce prostate cancer cell death, raising the possibility that vitamin D deficiency over time promotes the progression of subclinical PCa to clinical disease. These considerations support the use of vitamin D3 as a chemopreventive agent.

We hypothesize that a daily dose of vitamin D3 (4,000 IU) taken for one year by Veterans diagnosed with low-risk, early-stage PCa, who are eligible for active surveillance will: a) result in a measurable decrease of serum PSA levels in a significant number of enrolled subjects, and b) be associated with a stabilization or improvement of their PCa pathology, as assessed through histological examination of prostate tissue biopsy specimens (Gleason score and percent of positive biopsies) obtained at the end of the study, as part of their standard medical care for active surveillance.

This VA Merit application proposes to conduct a randomized, placebo-controlled clinical study aimed at measuring the efficacy of vitamin D3 (4000IU/day) supplementation in Veterans diagnosed with early-stage prostate cancer, who elect to have their disease monitored through active surveillance (before considering definitive therapy). The main objectives of this proposed clinical study are as follows:

1. To determine whether a daily supplement of 4,000 IU of vitamin D3 taken for twelve months will result in a measurable and significant decrease of serum PSA levels in Veterans diagnosed with low-risk, early stage PCa (Gleason score 6, PSA 10, clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.
2. To determine in enrolled Veterans the pathology status of their PCa by analyzing prostate tissue biopsy specimens at the end of the study (Gleason score and percentage of positive biopsies), and by comparing them with those obtained before enrollment in this study, as part of their standard medical care.

The implementation of these proposed studies will allow us to assess whether vitamin D3 supplementation can be utilized as a chemopreventive regimen in Veterans diagnosed with low-risk, early stage PCa, and provide a useful addition to active surveillance.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 83 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer
• Actual Study Start Date: January 7, 2010
• Actual Primary Completion Date: December 15, 2013
• Actual Study Completion Date: October 30, 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: Vitamin D3; 4,000 IU vitamin D3 daily for one year	Drug: vitamin D3; 4,000 IU daily for one year
Placebo Comparator: Placebo; Placebo daily for one year	Drug: Placebo daily for one year; Placebo

Outcome Measures

Primary Outcome Measures :

1. PSA Slope (Trajectory) or the Change in PSA Level Over Time [ Time Frame: 1 year (visits # 1-8) ]
   Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.

Secondary Outcome Measures :

1. Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment [ Time Frame: 1 year ]
   Change in the number of positive cores per subject from the pre-study prostate biopsy to the repeat prostate biopsy following study participation.

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Gender Eligibility Description: diagnosis of early-stage prostate cancer
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male Veterans (> 18 years of age) recently diagnosed with low-risk PCa (histologically documented adenocarcinoma of the prostate)
• A serum PSA value of up to 10.0 ng/ml, and a Gleason score of six or less (three or less in either architectural pattern)

• For the purpose of eligibility, these additional criteria will be verified: *serum creatinine 2.0 mg/dL

  • serum phosphate (measured as phosphorus) > 2.3 and < 4.8 mg/dL
  • serum calcium > 8.5 and < 10.5 mg/dL

Exclusion Criteria:

• Subjects with any concurrent malignancy, except non-melanoma skin cancer
• Subjects with a history of sarcoidosis
• Subjects with a history of high-dose (1,000 IU per day) vitamin D supplementation
• Subjects with a history of hypercalcemia
• Subjects who use lithium as a medication

Contacts and Locations

Locations

United States, South Carolina

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, United States, 29401-5799

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

VA Office of Research and Development

Medical University of South Carolina

Investigators

• Principal Investigator: Sebastiano Gattoni-Celli, MD; Ralph H. Johnson VA Medical Center, Charleston, SC

More Information

• Responsible Party: VA Office of Research and Development
• ClinicalTrials.gov Identifier: NCT00953225
• Other Study ID Numbers: CLIN-004-09S; MUSC IRB HR#19344 ( Other Identifier: MUSC IRB )
• First Posted: August 6, 2009
• Results First Posted: April 6, 2015
• Last Update Posted: October 9, 2017
• Last Verified: September 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:

prostate cancer; vitamin D

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vitamin D; Vitamins; Prostatic Diseases; Cholecalciferol; Micronutrients; Nutrients; Growth Substances; Physiological Effects of Drugs; Bone Density Conservation Agents; Calcium-Regulating Hormones and Agents