Vitamin D Effects on Prostate Pathology

There is much interest in understanding the role that vitamin D3 (cholecalciferol) plays in various cancers, and in the prognosis of various cancers once they are discovered. The purpose of this study is to examine the effects of vitamin D on prostate cancer-associated lesions and on vitamin D metabolites in prostate tissue. We will give vitamin D3 to men when they are scheduled to have their prostate removed because of cancer. The men will take vitamin D at one of 3 doses for 4-6 weeks, until the surgery is performed. We will compare the prostate tissue taken from the men receiving the higher doses of vitamin D to tissue from men assigned to the lower doses. We expect to find that the prostate removed at surgery from men who received the high-dose vitamin D treatment will appear more normal, and less cancer like. In addition, we will measure vitamin D metabolites in the prostate to confirm that these did accumulate in the prostate to bring about the effects observed.

Sex

Male

Minimum age

30 Years

Maximum age

85 Years

Inclusion Criteria:

* Diagnosis of a Gleason score 6 or 7 adenocarcinoma of the prostate biopsy
* Patient has elected to have a radical prostatectomy
* Patient is determined fit for surgery
* Normal renal and hepatic function
* Normal serum and urine calcium values
* Normal serum phosphate values
* Normal serum parathyroid hormone values
* Signed written informed consent

Exclusion Criteria:

* Prior use of neoadjuvant androgen deprivation therapy
* Prior use of 5 alpha reductase inhibitors (finasteride or dutasteride) in last 12 months
* Previous or concomitant anti-cancer therapy (chemotherapy, radiotherapy)
* Gleason score 8-10 adenocarcinoma as a biopsy diagnosis
* History of hypercalcemia/hypercalciuria
* History of renal disease
* History of sarcoidosis
* Vitamin D (cholecalciferol) supplement \> 1000 IU/day
* Inability to comply with a study protocol