Vitamin D in Treating Patients With Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: cholecalciferol

• Registration Number: NCT00524680
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

RATIONALE: Vitamin D may be effective in treating patients with prostate cancer.

PURPOSE: This randomized phase II trial is studying how well 4 different doses of vitamin D works in treating patients with prostate cancer.

Detailed Description

OBJECTIVES:

Primary

* To examine the pattern of response of serum 25(OH) D3 levels following cholecalciferol (vitamin D3) supplementation at four different oral doses in patients with prostate cancer.

Secondary

* To examine the pattern of response of parathormone (PTH) following vitamin D3 supplementation in these patients.

* To assess the toxicity of vitamin D3 supplementation in men with prostate cancer.

Tertiary

* To track occurrence of infections, deep vein thrombosis, vascular events, and falls in these patients.

OUTLINE: Patients are randomized to 1 of 4 treatment arms.

* Arm I: Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.

* Arm II: Patients receive 6,000 IU of vitamin D3 once daily.

* Arm III: Patients receive 8,000 IU of vitamin D3 once daily.

* Arm IV: Patients receive 10,000 IU of vitamin D3 once daily. Treatment in all arms continues for 6 months in the absence of disease progression or unacceptable toxicity.

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-08-31
• Study First Submitted QC: 2007-08-31
• Study First Posted: 2007-09-03
• Primary Completion: 2011-05
• Study Completion: 2013-03
• Results First Submitted: 2015-03-17
• Status Verified: 2015-09
• Results First Submitted QC: 2015-09-30
• Last Update Submitted: 2015-09-30
• Results First Posted: 2015-11-01
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 148

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm III	cholecalciferol	Patients receive 8,000 IU of vitamin D3 once daily.
Arm IV	cholecalciferol	Patients receive 10,000 IU of vitamin D3 once daily.
Arm I	cholecalciferol	Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.
Arm II	cholecalciferol	Patients receive 6,000 IU of vitamin D3 once daily.

Primary Outcome Measures

Name	Time	Method
Pattern of Response of Serum 25(OH) D3 Levels	Baseline, at 1, 3, 6 months	Change from Baseline in Serum 25(OH) D3 Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.

Secondary Outcome Measures

Name	Time	Method
Toxicity	Baseline, at 1, 3 and 6 months	Number of treated patients that had serious adverse events.
Pattern of Response of Parathormone	Baseline, at 1, 3, 6 months	Change from Baseline in PTH Levels at 1, 3, and 6 Months at dose levels 4000, 6000, 8000 and 10000 IU. Statistical analysis was done using one sample t-test.
Occurrence of Infections, Deep Vein Thrombosis, Vascular Events, and Falls	Baseline, at 1, 3 ,6 months	Number of participant with occurrence of infections, deep venous thrombosis, vascular events and falls

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States