Calcitriol in Treating Patients With a Rising PSA Level Following Treatment for Prostate Cancer
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|ClinicalTrials.gov Identifier: NCT00004043|
Recruitment Status : Completed
First Posted : June 17, 2004
Last Update Posted : April 28, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Dietary Supplement: calcitriol||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Pulse Calcitriol in Patients With Rising PSA After Definitive Treatment for Prostate Cancer|
|Study Start Date :||February 1999|
|Actual Primary Completion Date :||March 2003|
|Actual Study Completion Date :||March 2003|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004043
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Study Chair:||Tomasz Beer, MD||OHSU Knight Cancer Institute|