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This pilot clinical trial studies fludeoxyglucose F18 (FDG)-positron emission tomography (PET) in imaging patients with prostate cancer treated with ranolazine. Diagnostic procedures, such as FDG-PET, may help find prostate cancer and find out how far the disease has spread. Giving ranolazine may enhance FDG-PET imaging by increasing the amount of glucose available for uptake by the scan.
Full description
PET scans have traditionally not been very good at detecting prostate cancers. This is because prostate cancer cells do not take up glucose well so the signals are very weak. The ability of PET imaging to detect cancers requires that the cancer cells take up glucose into the cells. Different methods are being tested to see if we can improve the detection of prostate cancers using PET scans.
Ranolazine is a drug that is already approved by the FDA for treatment of chronic chest pain in people with heart disease. Ranolazine has been studied in the laboratories at the University of Colorado Denver, Anschutz Medical Campus. Ranolazine has been added to prostate cancer cells and grown in petri dishes and in animals in the laboratory. It has been shown to increase the glucose uptake of prostate cancer cells. The goal of this study is to see if patients taking ranolazine will have better PET imaging of their prostate cancers.
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Inclusion criteria
Exclusion criteria
Have small cell carcinoma or neuroendocrine component >50%.
Have a history of gastrointestinal disorders (medical disorders or extensive surgery) that may interfere with the absorption of ranolazine.
Documented hypersensitivity to any component of ranolazine (Ranexa®) pills.
Need for medications that are:
Have corrected QT interval (QTc)> 450 msec (male) or > 470 msec (female) on 12-lead electrocardiogram.
Poorly controlled diabetes, hemoglobin A1c (Hgb A1C) >9 or random blood glucose >250mg/dL.
Active or symptomatic viral hepatitis or chronic liver disease.
Clinically significant heart disease as evidenced by:
Active infection requiring antibiotics.
Major surgery or radiation treatment within 3 months.
Cytotoxic chemotherapy within 4 weeks.
Immunotherapy within 6 months.
Any prior therapy with Radium-223, Samarium, or Strontium.
Arm 1 patients may not have received any prior luteinizing-hormone-releasing hormone (LHRH) agonists/antagonists, anti-androgens, or chemotherapy for their prostate cancer. 5-alpha reductase inhibitors (finasteride, dutasteride) may be allowed.
Have any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
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11 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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