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

NCT01759771 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: CLIN-007-12SPro00019745
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 2

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 1,25 dihydroxyvitamin D3 (VD3) 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).

Conditions

Prostate Cancer

Keywords

Prostate Cancer; Vitamin D3; Active surveillance

Outcome Measures

Primary Outcomes (1)

• Pathology Status

  pathology status will be measured by 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.

  one year

Secondary Outcomes (2)

• Number of Veteran Subjects Who Will Undergo Additional Treatment

  2 years

• PSA and Serum Vitamin D

  One year

Study Arms (2)

Arm 1

EXPERIMENTAL

4,000 IU of VD3 for one year

Drug: Vitamin D3

Arm 2

PLACEBO COMPARATOR

placebo for one year

Drug: Placebo

Interventions

Vitamin D3 DRUG

4,000 IU of VD3 for at least one year

Arm 1

Placebo DRUG

Placebo for at least one year

Arm 2

Eligibility Criteria

• Age: 19 Years - 90 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 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

You may not qualify if:

• 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

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

Limitations and Caveats

The study is limited by the potential challenges associated with needle biopsy as opposed to full pathologic specimens.

Results Point of Contact

• Title: Stephen J. Savage, MD, Chief Section of Urology
• Organization: Ralph H. Johnson Veterans Affairs Medical Center

savages@musc.edu

843 789 7330

Study Officials

• Sebastiano Gattoni-Celli, MD

  Ralph H. Johnson VA Medical Center, Charleston, SC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: December 27, 2012
• First Posted: January 3, 2013
• Study Start: January 3, 2013
• Primary Completion: October 18, 2018
• Study Completion: May 11, 2020
• Last Updated: March 18, 2024
• Results First Posted: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)