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Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial (VD3PCa)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01759771
Recruitment Status : Completed
First Posted : January 3, 2013
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Medical University of South Carolina
Information provided by (Responsible Party):
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE December 27, 2012
First Posted Date  ICMJE January 3, 2013
Last Update Posted Date June 25, 2020
Actual Study Start Date  ICMJE January 3, 2013
Actual Primary Completion Date October 18, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2016)
Pathology Status [ Time Frame: one year ]
pathology status will be measured by the change in Gleason score and the number of positive cores in prostate needle biopsy specimens between baseline and the repeat standard of care prostate biopsy at the end of the study.
Original Primary Outcome Measures  ICMJE
 (submitted: December 27, 2012)
Pathology Status [ Time Frame: one year ]
pathology status will be measured by the change in Gleason score and the number of positive cores in prostate needle biopsy specimens between baseline and the end of the study.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2012)
  • Number of Veteran subjects who will undergo additional treatment [ Time Frame: more than one year ]
    To determine whether vitamin D3 supplementation, compared to placebo, will result in a significant decrease in the number of Veteran subjects who will undergo additional treatment (prostatectomy or radiation therapy), following the outcome of repeat biopsy.
  • PSA and serum Vitamin D [ Time Frame: One year ]
    To analyze changes in the serum levels of cholecalciferol, 25(OH)D, 1,25(OH)2D, and prostate-specific antigen (PSA) at baseline and at the end of the study, and to estimate the associations between changes in these measures and pathology outcomes (Gleason score and number of positive cores).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial
Official Title  ICMJE Vitamin D3 Supplementation for Low-Risk Prostate Cancer: A Randomized Trial
Brief Summary Vitamin D promotes the differentiation of prostate cancer cells and maintains the differentiated phenotype of prostate epithelial cells. The results of the investigators' clinical studies indicate that vitamin D3 supplementation results in a decrease of positive cancer cores at repeat biopsy in subjects with low-risk prostate cancer. The investigators hypothesize that Veterans who have early-stage prostate cancer and who take vitamin D3 at 4000 international units per day (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing definitive treatment (prostatectomy or radiation therapy), compared to Veteran subjects taking placebo (control group).
Detailed Description

The central hypothesis of this grant application is that vitamin D3 (cholecalciferol) supplementation will benefit Veteran subjects diagnosed with early-stage, low-risk prostate cancer, who elect to have their disease monitored through active surveillance. Specifically, the investigators hypothesize that Veterans who take vitamin D3 at a daily dose of 4000 international units (IU) for a minimum of one year (intervention group) will show an improvement in the number of positive cores and in Gleason score at repeat biopsy, and a decreased likelihood of undergoing additional treatment (hormone therapy, prostatectomy or radiation therapy), compared to Veterans taking placebo (control group).

To test this hypothesis, the investigators propose the following Specific Aims:

  1. To determine whether vitamin D3 (4,000 IU per day FOR AT LEAST ONE YEAR) will result in a significant improvement of the pathology status at repeat biopsy in Veteran subjects taking vitamin D3, compared to Veteran subjects taking placebo. This hypothesis will be tested through a randomized clinical trial, which will enroll 136 Veteran subjects (68 participants per arm), diagnosed with early-stage prostate cancer (Gleason score 6, PSA 10, clinical stage T1C or T2a). The pathology status will be measured by the change in Gleason score and the number of positive cores in prostate needle biopsy specimens between baseline and the end of the study. Pre- and post-study biopsies will be performed as part of the standard medical care for diagnosis and active surveillance.
  2. To determine whether vitamin D3 supplementation, compared to placebo, will result in a significant decrease in the number of Veteran subjects who will undergo additional treatment (hormone therapy, prostatectomy or radiation therapy), following the outcome of repeat biopsy.
  3. To analyze changes in the serum levels of cholecalciferol, 25(OH)D, 1,25(OH)2D, and prostate-specific antigen (PSA) at baseline and at the end of the study, and to estimate the associations between changes in these measures and pathology outcomes (Gleason score and number of positive cores).
  4. To compare the expression of molecular biomarkers, which are prognostically relevant to prostate cancer progression, in pre- and post- treatment biopsy tissue specimens. Paraffin-embedded sections will be processed to assess by immunohistochemical techniques the expression of the following biomarkers: Vitamin D Receptor (VDR), P21, Tumor Growth Factor (TGF ), Cyclooxygenase 2 (COX-2), and NF B. All of these protein products impact growth control and chronic inflammation in prostate cancer progression and are specifically affected by Vitamin D status.

Implementation of the proposed studies would demonstrate that Vitamin D3 supplementation provides a welcome addition to active surveillance, since patients who respond to Vitamin D3 supplementation (as indicated by a decrease in score or number of positive cores at repeat biopsy) can safely continue active surveillance and would not need definitive treatment. In turn, this would result in a decreased likelihood of overtreatment. On the other hand, subjects who progress after Vitamin D3 supplementation, as indicated by an increase in Gleason score or number of positive cores at repeat biopsy, may have more aggressive disease and may need to consider definitive treatment. Therefore, both groups of patients (responders as well as non-responders) would benefit from Vitamin D3 supplementation, an intervention strategy that is extremely cost-effective and easy to implement.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: Vitamin D3
    4,000 IU of VD3 for at least one year
  • Drug: Placebo
    Placebo for at least one year
Study Arms  ICMJE
  • Experimental: Arm 1
    4,000 IU of VD3 for one year
    Intervention: Drug: Vitamin D3
  • Placebo Comparator: Arm 2
    placebo for one year
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 23, 2020)
130
Original Estimated Enrollment  ICMJE
 (submitted: December 27, 2012)
136
Actual Study Completion Date  ICMJE May 11, 2020
Actual Primary Completion Date October 18, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male 19 - 90 years old - Low-grade prostate cancer
  • Clinical Stage T1C or T2a
  • Serum PSA < 10.0 ng/ml
  • Gleason Score < or = to 6 (either architectural pattern < or = to 3)
  • Decision to monitor prostate cancer in Active Surveillance
  • Serum creatinine < 2.0 mg/dL
  • Serum phosphorus > 2.3 and < 4.8 mg/dL
  • Serum calcium > 8.5 and < 10.5 mg/dL
  • Must be capable of giving consent to participate in the study

Exclusion Criteria:

  • Any concurrent malignancy, except non-melanoma skin cancer
  • History of sarcoidosis
  • History of Primary Hyperparathyroidism
  • History of hypercalcemia
  • Vitamin D supplementation > 2,000 IU daily
  • Lithium medication
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Diagnosis of Early-stage Prostate Cancer
Ages  ICMJE 19 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01759771
Other Study ID Numbers  ICMJE CLIN-007-12S
Pro00019745 ( Other Identifier: Medical University of South Carolina IRB )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party VA Office of Research and Development
Study Sponsor  ICMJE VA Office of Research and Development
Collaborators  ICMJE Medical University of South Carolina
Investigators  ICMJE
Principal Investigator: Sebastiano Gattoni-Celli, MD Ralph H. Johnson VA Medical Center, Charleston, SC
PRS Account VA Office of Research and Development
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP