Vitamin D3 Supplementation in Participants Diagnosed With Early-Stage Prostate Cancer Who Decide to Undergo Active Surveillance Treatment Regimen. (D3/PCa)

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 2

Conditions: Prostate Cancer

Treatments: Dietary Supplement: cholecalciferol

Study type: Interventional

Funder types: Other

Identifiers

NCT01045109

MUSC HR# 17398 (Other Identifier)

CTO# 101121 (Other Identifier)

MUSC CTRC #790 (Other Identifier)

CTRF #P-06-068

Details and patient eligibility

About

This clinical trial is aimed at measuring the effect of vitamin D3 supplementation on serum prostate-specific antigen (PSA) levels in patients diagnosed with early stage, low-grade, low-risk prostate cancer (Gleason score less than/equal to 6; PSA less than/equal to 10; clinical stage T1C or T2a), who elect to have their disease monitored through active surveillance for at least one year.

Enrollment: 52 patients

Sex: Male

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

open-label vitamin D3

Experimental group

Description:

One arm: open-label receiving vitamin D3 4,000 IU daily

Treatment:

Dietary Supplement: cholecalciferol

Dietary Supplement: cholecalciferol