D Vitamin in Treating Patients with Early Stage Prostate Cancer

PRIMARY OBJECTIVES:

I. To determine whether vitamin D3 (4,000 IU per day for at least one year) will result in a significant improvement of the pathology status at repeat biopsy in veteran subjects taking vitamin D3, compared to veteran subjects taking placebo.

II. To determine whether vitamin D3 supplementation, compared to placebo, will result in a significant decrease in the number of veteran subjects who will undergo additional treatment (hormone therapy, prostatectomy, or radiation therapy), following the outcome of repeat biopsy.

III. To analyze changes in the serum levels of cholecalciferol, 25(OH)D, 1,25(OH)2D, and prostate-specific antigen (PSA) at baseline and at the end of the study, and to estimate the associations between changes in these measures and pathology outcomes (Gleason score and number of positive cores).

IV. To compare the expression of molecular biomarkers, which are prognostically relevant to prostate cancer progression, in pre- and post-treatment biopsy tissue specimens.

V. To determine psychological and physiological stress response for patients involved in prostate cancer screening and treatment options by administering a survey about the patients’ prostate biopsy decision making experience and obtaining measurements (Allostatic load parameters) of stress response at the beginning and end of the study visits.

OUTLINE: Patients are randomized into 1 of 2 arms.

ARM I: Patients receive D vitamin orally (PO) once daily (QD) for at least 1 year in the absence of disease progression or unaccepted toxicity.

ARM II: Patients receive placebo PO QD for at least 1 year in the absence of disease progression or unaccepted toxicity.

After completion of study treatment, patients are followed up within 16 weeks.