Vitamin D Supplementation in Veterans With Early-Stage Prostate Cancer

NCT00953225 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CLIN-004-09SMUSC IRB HR#19344
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

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.

Conditions

Prostate Cancer

Keywords

prostate cancer; vitamin D

Outcome Measures

Primary Outcomes (1)

• PSA Slope (Trajectory) or the Change in PSA Level Over Time

  Change in PSA (ng/mL) from baseline to 1 year visit, which include the baseline through 1 year follow-up.

  1 year (visits # 1-8)

Secondary Outcomes (1)

• Number of Positive Biopsy Cores (Out of Twelve) Compared to the Corresponding Values Assessed Before Enrollment

  1 year

Study Arms (2)

Vitamin D3

EXPERIMENTAL

4,000 IU vitamin D3 daily for one year

Drug: vitamin D3

Placebo

PLACEBO COMPARATOR

Placebo daily for one year

Drug: Placebo daily for one year

Interventions

vitamin D3 DRUG

4,000 IU daily for one year

Vitamin D3

Placebo daily for one year DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 19 Years - 85 Years
• Gender Eligibility Details: diagnosis of early-stage prostate cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Medical University of South Carolina: collaborator

Study Sites (2)

Ralph H. Johnson VA Medical Center, Charleston, SC

Charleston, South Carolina, 29401-5799, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Results Point of Contact

• Title: Sebastiano Gattoni-Celli, M.D.
• Organization: Ralph H. Johnson VA Medical Center

gatttonis@musc.edu

843-876-5103

Study Officials

• Sebastiano Gattoni-Celli, MD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2009
• First Posted: August 6, 2009
• Study Start: January 7, 2010
• Primary Completion: December 15, 2013
• Study Completion: October 30, 2014
• Last Updated: October 9, 2017
• Results First Posted: April 6, 2015

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)