Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
OBJECTIVES: I. Determine the response to pulse calcitriol in patients with previously
treated adenocarcinoma of the prostate with rising PSA levels. II. Assess the impact of this
regimen on the slope of the PSA rise in these patients. III. Determine the qualitative and
quantitative toxic effects of this regimen in these patients. IV. Assess the impact of this
regimen on the quality of life of these patients.
OUTLINE: All patients remain on a reduced calcium diet for the duration of the study. Twelve
hours prior to treatment, patients begin drinking 4-6 glasses of extra fluid for 3 days.
Patients receive oral calcitriol over 4 hours weekly. Treatment continues in the absence of
disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every
4 weeks during treatment, and at the end of the study. Patients are followed for at least 1
PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Tomasz Beer, MD
OHSU Knight Cancer Institute
United States: Federal Government
|OHSU Knight Cancer Institute||Portland, Oregon 97239|