Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2025-12-24 @ 9:25 PM
NCT ID:
NCT00887432
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT00887432
Study Brief:
Protocol Section:
NCT00887432