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Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer
RATIONALE: Calcitriol, a form of vitamin D, may be able to prevent or slow the growth of prostate cancer cells. PURPOSE: Phase II trial to study the effectiveness of calcitriol in treating patients who have a rising PSA level following previous 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 month. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Age
18 - 120 years
Sex
MALE
Healthy Volunteers
No
OHSU Knight Cancer Institute
Portland, Oregon, United States
Start Date
February 1, 1999
Primary Completion Date
March 1, 2003
Completion Date
March 1, 2003
Last Updated
April 28, 2017
25
ACTUAL participants
calcitriol
DIETARY_SUPPLEMENT
Lead Sponsor
OHSU Knight Cancer Institute
NCT04550494
NCT05691465
Data Source & Attribution
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