Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Rutgers, The State University of New Jersey
With
OBJECTIVES: * Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia. * Determine the toxicity of this drug in these patients. * Determine the effect of this drug on prostate specific antigen in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms. * Arm I: Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses in the absence of unacceptable toxicity. After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol. Patients with no HGPIN or prostate cancer by biopsy are removed from the study. * Arm II: Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I. Patients with no HGPIN or prostate cancer by biopsy are removed from the study. After completion of study treatment, patients are followed annually for 2 years. PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.
Age
18–any
Sex
MALE
Healthy volunteers
Not accepted
