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


Condition: Prostate Adenocarcinoma

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT00887432

Sponsor: Roswell Park Cancer Institute

Eligibility:

  • Age: minimum 18 Years maximum N/A
  • Gender: Male

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

View trial on ClinicalTrials.gov