Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
NCT ID: NCT00887432
Last Updated: 2021-10-26
Study Results
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View full resultsBasic Information
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COMPLETED
NA
132 participants
INTERVENTIONAL
2009-04-08
2020-06-08
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Arm I (cholecalciferol and placebo)
Patients receive cholecalciferol 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 II.
Cholecalciferol
Given PO
Laboratory Biomarker Analysis
Correlative studies
Patient Observation
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (placebo and cholecalciferol)
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.
Cholecalciferol
Given PO
Laboratory Biomarker Analysis
Correlative studies
Patient Observation
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Cholecalciferol
Given PO
Laboratory Biomarker Analysis
Correlative studies
Patient Observation
Placebo Administration
Given PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Willingness to comply with study guidelines
* Willingness and ability to consent
* 25(OH) D3 level less than 40 ng/ml within 3 months of initiation of study; most recent 25 hydroxy D level within last 3 month would be used
Exclusion Criteria
* Creatinine \> 2.0 mg/dL
* Corrected serum calcium level of \> 10.5 mg/dL (serum corrected calcium = serum calcium + 0.8\[4-serum albumin\])
* Most recent PSA value more than 18 months ago
* Prior or current therapy for prostate cancer
* Documented history of nephrolithiasis within the past 5 years
* Patients receiving finasteride (Proscar) or dutasteride (Avodart) or men who have received either agent within 90 days of entry are ineligible
* Patients cannot take any additional vitamin D supplementation during study treatment; patients taking \> 2000 IU per day prior to treatment will be ineligible
18 Years
MALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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James Mohler
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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NCI-2009-01530
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 128308
Identifier Type: OTHER
Identifier Source: secondary_id
I 128308
Identifier Type: -
Identifier Source: org_study_id