Status and phase
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About
To determine if dexamethasone or dexamethasone plus metronidazole restore sensitivity to abiraterone for the treatment of metastatic prostate cancer.
Enrollment
Sex
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Volunteers
Inclusion criteria
Exclusion criteria
Active infection or other medical condition that would make dexamethasone use contraindicated
Any chronic medical condition requiring a higher systemic dose of corticosteroid
Pathological finding consistent with small cell carcinoma of the prostate
Has imminent or established spinal cord compression based on clinical findings and/or MRI.
Chronic liver disease with Child-Pugh class C cirrhosis (see calculator in protocol)
Bilirubin >3x ULN or AST and ALT >5x ULN
Congenital prolonged QTc syndrome or QTc > 500 msec (non-paced rhythm)
History of pituitary or adrenal dysfunction
Uncontrolled diabetes (Hemoglobin A1c > 10%) or increasing doses of insulin within the past 4 weeks due to poorly controlled glucoses.
Administration of an investigational therapeutic or invasive surgical procedure (not including surgical castration) within 30 days of Cycle 1 Day 1 or currently enrolled in an investigational drug study
Any other serious illness or medical condition that would, in the opinion of the investigator, make this protocol unreasonably hazardous, including, but not limited to:
On antibacterial therapy within 30 days prior to administration of study treatment.
Any condition or situation which, in the opinion of the investigator, would put the subject at risk, or interfere with the subject's participation in this study.
Primary purpose
Allocation
Interventional model
Masking
58 participants in 2 patient groups
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Central trial contact
Irina Rifkind, RN; Sin Chan
Data sourced from clinicaltrials.gov
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