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Vitamin D and Prostate Cancer


Phase 2
18 Years
90 Years
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Vitamin D and Prostate Cancer


Inclusion Criteria:



- lowgrade prostate cancer

- serum PSA less than/equal to 10 ng/ml

- Gleason score less than/equal to 6

- referred from their treating physician with treatment plan of active surveillance for
one year

- serum creatinine less than/equal to 2.0 mg/dL

- serum phosphate (measured as phosphorus)greater than 2.3 and less than 4.8 mg/dL

- serum calcium greater than 8.5 and less than 10.5 mg/dL

Exclusion Criteria:

- concurrent malignancy, except non-melanoma skin cancer

- history of sarcoidosis

- history of high dose (greater than 1,000 IU daily) vitamin D3 supplementation

- history of hypercalcemia

- treatment with lithium medication

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Effect of vitamin D3 supplementation on prostate specific antigen levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer.

Outcome Time Frame:

48 weeks

Safety Issue:

Yes

Principal Investigator

Sebastiano Gattoni-Celli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

MUSC Department of Radiation Oncology

Authority:

United States: Food and Drug Administration

Study ID:

CTRF #P-06-068

NCT ID:

NCT01045109

Start Date:

October 2007

Completion Date:

July 2011

Related Keywords:

  • Prostate Cancer
  • prostate
  • cancer
  • vitamin D3
  • early stage
  • active surveillance
  • Prostatic Neoplasms

Name

Location
Medical University of South Carolina Charleston, South Carolina  29425-0721