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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00953225
First received: August 4, 2009
Last updated: June 4, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Prostate Cancer
Drug: vitamin D3
Drug: Placebo daily for one year
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • PSA slope (trajectory) or the change in PSA level over time [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of positive biopsy cores (out of twelve) compared to the corresponding values assessed before enrollment [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: January 2010
Estimated Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
4,000 IU vitamin D3 daily for one year
Drug: vitamin D3
4,000 IU daily for one year
Placebo Comparator: Arm 2
Placebo daily for one year
Drug: Placebo daily for one year
Placebo

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.

  Eligibility

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Male
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00953225

Locations
United States, South Carolina
Ralph H Johnson VA Medical Center, Charleston
Charleston, South Carolina, United States, 29401-5799
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
Principal Investigator: Sebastiano Gattoni-Celli, MD Ralph H Johnson VA Medical Center, Charleston
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00953225     History of Changes
Other Study ID Numbers: CLIN-004-09S, MUSC IRB HR#19344
Study First Received: August 4, 2009
Last Updated: June 4, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Department of Veterans Affairs:
prostate cancer
vitamin D

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 22, 2014