Elaine Lam, MD, University of Colorado, Denver
A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine
Adenocarcinoma of the Prostate
Soft Tissue Metastases
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Stage III Prostate Cancer
Stage IV Prostate Cancer
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.
Ages Eligible: 19 Years
Accepts Healthy Volunteers:
1. Written informed consent has been obtained.
2. Adults over 18 years of age.
3. Histological or cytologically confirmed prostate adenocarcinoma.
4. Arm 1 patients must have treatment-naïve, Gleason ≥ 7 prostate cancer based on
transrectal ultrasound (TRUS) biopsy, have localized disease, and have decided to
undergo radical prostatectomy (open or robotic) as definitive treatment for their
5. Arm 2 patients must have lymph node, soft tissue, bone, or visceral metastatic
disease measuring ≥ 1 cm (lytic component if bone), documented by either CT or MRI
imaging within 6 weeks of signing consent. Arm 2 patients may have hormone-sensitive
or castrate-resistant disease and may be receiving treatment with hormonal therapies.
6. For Arm 1 patients, the time from the TRUS prostate biopsy to the planned first study
PET scan must be ≥ 1 month. For patients who have undergone prior prostate mapping
biopsy, the time from the mapping biopsy to the planned first study PET scan must be
≥ 2 months.
7. For Arm 1 patients, participation in this study, in the opinion of the treating
physicians, will not introduce delays in surgery that would adversely affect the
8. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
9. Fasting blood glucose ≤ 120 mg/dL.
10. Adequate renal function (Creatinine ≤ 1.5 X ULN)
11. Adequate hepatic function (bilirubin < 1.5 X upper limit of normal (ULN), alanine
aminotransferase (ALT) < 1.5 X ULN, aspartate aminotransferase (AST) < 1.5 X ULN, and
albumin ≥ 3 g/dL. For patients with known bone metastases, alkaline phosphatase < 5
X ULN is acceptable.
12. Must be able to take oral medication without crushing, dissolving or chewing tablets.
13. Written authorization for use and release of health and research study information
has been obtained.
14. Patients who have partners of childbearing potential must be willing to use a method
of birth control with adequate barrier protection during the study and for 1 week
after the last dose of ranolazine.
1. Have small cell carcinoma or neuroendocrine component >50%.
2. Have a history of gastrointestinal disorders (medical disorders or extensive surgery)
that may interfere with the absorption of ranolazine.
3. Documented hypersensitivity to any component of ranolazine (Ranexa®) pills.
4. Need for medications that are strong cytochrome P450, family 3, subfamily A (CYP3A)
inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir,
ritonavir, indinavir, saquinavir), moderate CYP3A inhibitors (e.g. diltiazem,
verapamil, erythromycin, fluconazole, grapefruit juice or grapefruit-containing
products), CYP3A inducers (e.g. rifampin, rifabutin, rifapentine, phenobarbital,
phenytoin, carbamazepine, St. John's wort), CYP3A substrates with a narrow
therapeutic range (e.g. cyclosporine, tacrolimus, sirolimus), P-gp inhibitors or
substrates (e.g. cyclosporine, digoxin), polypeptide 6 (CYP2D6) substrates (e.g.
tricyclic antidepressants and antipsychotics),or simvastatin at doses > 20 mg/day.
5. Have corrected QT interval (QTc)> 450 msec (male) or > 470 msec (female) on 12-lead
6. Poorly controlled diabetes, hemoglobin A1c (Hgb A1C) >9 or random blood glucose
7. Active or symptomatic viral hepatitis or chronic liver disease.
8. Clinically significant heart disease as evidenced by myocardial infarction, or
arterial thrombotic events in the past 6 months, severe or unstable angina, or New
York Heart Association Class III-IV heart disease or cardiac ejection fraction
measurement of <50%.
9. Active infection requiring antibiotics.
10. Major surgery or radiation treatment within 3 months.
11. Cytotoxic chemotherapy within 4 weeks.
12. Immunotherapy within 6 months.
13. Any prior therapy with Radium-223, Samarium, or Strontium.
14. 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.
15. 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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Information obtained from ClinicalTrials.gov, on
7/31/2015. For additional information about
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