Prostate cancer is a common occurrence in the aging population, with one in ten men destined to develop the disease. 40% of patients with prostate cancer experience a recurrence after definitive treatment. This study addresses the as-yet unresolved problem of the optimal management of early recurrence as manifested by increase in the accepted marker for this disease, PSA. Vitamin D, an agent with cell-differentiating properties, has been shown to inhibit angiogenesis and cause differentiation of prostate cancer cells in the laboratory and to affect PSA favorably in clinical studies of patients with advanced prostate cancer. This study will assess the effects of vitamin D in patients with sub-clinical biochemical relapses of prostate cancer as indicated by rising PSA but low tumor burdens, with the potential for developing an approach to this problem that will delay or prevent progression.

Condition	Treatment or Intervention	Phase
Prostate Cancer	Drug: calcifidiol	Phase II

Genders Eligible for Study:  Male

Criteria

Patients will be males with three successive rises in PSA after achieving a nadir post-definitive therapy. The following criteria must be met: pathologically confirmed prostate cancer, completion of definitive treatment in the form of local external beam radiation or definitive surgery and three successive rises in PSA with no clinical evidence of disease.

Florida
      VAMC Miami, FL, Miami,  Florida,  33125,  United States; Recruiting

Study chairs or principal investigators

Guy Howard, Ph.D
Gary Schwartz, Ph.D, MPH
James Schlesselman, Ph.D

Study ID Numbers:  ONCO-09-99S
Record last reviewed:  June 2001
Record first received:  July 3, 2001
ClinicalTrials.gov Identifier:  NCT00018538
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-16