NCT00887432

Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation

Randomized Placebo-Controlled, Double-Blind Study of Cholecalciferol Replacement in Patients on Expectant Management for Localized Prostate Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized clinical trial studies how well cholecalciferol supplement works in treating patients with localized prostate cancer undergoing observation. Cholecalciferol may help prostate cancer cells become more like normal cells, and to grow and spread more slowly.

Detailed description

PRIMARY OBJECTIVES: I. To determine the prostate-specific antigen (PSA) response with oral high dose vitamin D3 supplementation (cholecalciferol) in patients with localized, histologically proven adenocarcinoma of the prostate who have not received any treatment for prostate cancer ever and have chosen expectant management. SECONDARY OBJECTIVES: I. To examine the pattern of response of PSA dynamics as well as the absolute change in PSA following vitamin D3 supplementation. II. Assess the toxicity of vitamin D3 supplementation in men with prostate cancer. TERTIARY OBJECTIVES: I. Track occurrence of infections, deep venous thrombosis, vascular events and falls in the study population. II. To evaluate relationship between cytochrome P450 family 24 (CYP24), 27B1, single-nucleotide polymorphism (SNPs) and serum 25(hydroxy \[OH\]) vitamin D response to oral D3 supplementation. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive cholecalciferol orally (PO) once daily (QD) for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm II. ARM II: Patients receive placebo PO QD for 9 months in the absence of disease progression or unacceptable toxicity. After a wash-out period of 3 months, patients cross-over to Arm I. After completion of study treatment, patients are followed up for 30 days.

Conditions

• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Cholecalciferol	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Patient Observation
DRUG	Placebo Administration	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2009-04-08
• Primary completion: 2020-06-08
• Completion: 2020-06-08
• First posted: 2009-04-24
• Last updated: 2021-10-26
• Results posted: 2021-08-10

Locations

1 site across 1 country: United States