Vitamin D in Treating Patients With Prostate Cancer

Phase 2

Completed

• Conditions: Prostate Cancer

• 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

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