Status:
COMPLETED
Cholecalciferol Supplement in Treating Patients With Localized Prostate Cancer Undergoing Observation
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostate Adenocarcinoma
Eligibility:
MALE
18+ years
Phase:
NA
Brief 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 ce...
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 ade...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 8 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 8 2020
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT00887432
Start Date
April 8 2009
End Date
June 8 2020
Last Update
October 26 2021
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263