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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
Buffalo, New York, United States, 14263
- Roswell Park Cancer Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Any patient with clinically localized, histologically proven adenocarcinoma of prostate who has not received any treatment for prostate cancer ever and has chosen active surveillance; treatment for prostate cancer is defined as prostatectomy, androgen deprivation, brachytherapy or a full course of external beam irradiation
- 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:
- History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Given PO
Other Names:
Other Names:
|
|
Experimental: 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.
|
Correlative studies
Ancillary studies
Other Names:
Ancillary studies
Given PO
Given PO
Other Names:
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PSA Response
Time Frame: 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment
|
Difference in the mean change in PSA on vitamin D (9 month period: pre-Vitamin D to 9 months after start of vitamin D) versus on placebo (9 month period: pre-Placebo to 9 months after starting placebo). Compared using a paired t-test. |
9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Slope of PSA Concentration Over Time
Time Frame: 9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment
|
The PSA levels were modeled as a function of treatment, time, their interaction, sequence, and a random subject effect using a linear mixed model.
From this model, the subject specific PSA slope was obtained for each subject under each condition (vitamin D versus placebo).
The PSA slopes were then compared between treatment conditions using linear mixed model to account for treatment arm and repeated measures.
|
9 month period: pre-Vitamin D/pre-placebo to 9 months after start of vitamin D/ placebo, up to 30 days after completion of study treatment -Up to 30 days after completion of study treatment
|
|
Toxicity as Assessed by National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
Time Frame: Up to 30 days after completion of study treatment (up to 22 months from start of study).
|
Summarizing the maximum observed treatment related adverse event.
Summarize by arm and grade using frequencies and relative frequencies..
|
Up to 30 days after completion of study treatment (up to 22 months from start of study).
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: James Mohler, Roswell Park Cancer Institute
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I 128308 (Other Identifier: Roswell Park Cancer Institute)
- P30CA016056 (U.S. NIH Grant/Contract)
- NCI-2009-01530 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
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