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A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992016
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : June 4, 2018
Last Update Posted : December 3, 2018
Sponsor:
Information provided by (Responsible Party):
University of Colorado, Denver

Tracking Information
First Submitted Date  ICMJE November 12, 2013
First Posted Date  ICMJE November 25, 2013
Results First Submitted Date  ICMJE April 11, 2018
Results First Posted Date  ICMJE June 4, 2018
Last Update Posted Date December 3, 2018
Actual Study Start Date  ICMJE April 7, 2014
Actual Primary Completion Date October 8, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2018)
Number of Participants With Increase in SUV Uptake [ Time Frame: Within 1 week after completion of ranolazine treatment ]
Number of participants who had increased SUV uptake, as defined by any of the following:
  1. SUVmax increase of 30% with a 2 unit absolute change.
  2. SUVmean increase of 30% with a 0.75 unit absolute change.
  3. SUVmean increase of 20% with a 1 unit absolute change.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Rate of successful enhancement of FDG-PET imaging [ Time Frame: Within 1 week after completion of ranolazine treatment ]
The proportion of success and its exact 90% confidence limits will be reported for each of the two arms.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
  • Quantitative change in FDG-PET imaging [ Time Frame: Within 1 week after completion of ranolazine treatment ]
    T-test or logistic regression will be used to assess if there is any difference in tumor size between the enhanced and not enhanced imagining. Logistic regression will be used to evaluate if tumor size is associated with the outcome. Effect size (from t-test) and odds ratio (from logistic regression) will be reported. Successful enhancement rate for each tumor location will be summarized.
  • Rate of successful enhancement of FDG-PET imaging [ Time Frame: Within 1 week after completion of ranolazine treatment ]
    The proportion of success and its exact 90% confidence limits will be reported for each of the two arms.
  • Quantitative change in PET imaging signal [ Time Frame: Within 1 week after completion of ranolazine treatment ]
    The proportion of success and its exact 90% confidence limits will be reported for each of the two arms.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine
Official Title  ICMJE A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine
Brief Summary 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Adenocarcinoma of the Prostate
  • Bone Metastases
  • Soft Tissue Metastases
  • Stage IIA Prostate Cancer
  • Stage IIB Prostate Cancer
  • Stage III Prostate Cancer
  • Stage IV Prostate Cancer
Intervention  ICMJE Drug: Ranolazine
1000mg given orally twice daily for 1 day (2 doses).
Other Name: Ranexa
Study Arms  ICMJE
  • Experimental: Arm I (localized prostate cancer)
    Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. Patients may then undergo robotic or open radical prostatectomy.
    Intervention: Drug: Ranolazine
  • Experimental: Arm II (metastatic prostate cancer)
    Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.
    Intervention: Drug: Ranolazine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 7, 2016)
11
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
40
Actual Study Completion Date  ICMJE April 11, 2018
Actual Primary Completion Date October 8, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  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 prostate cancer.
  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 patient.
  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.

Exclusion Criteria:

  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:

    1. strong cytochrome P450, family 3, subfamily A (CYP3A) inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, nelfinavir, ritonavir, indinavir, saquinavir),
    2. moderate CYP3A inhibitors (e.g. diltiazem, verapamil, erythromycin, fluconazole, grapefruit juice or grapefruit-containing products),
    3. CYP3A inducers (e.g. rifampin, rifabutin, rifapentine, phenobarbital, phenytoin, carbamazepine, St. John's wort),
    4. CYP3A substrates with a narrow therapeutic range (e.g. cyclosporine, tacrolimus, sirolimus),
    5. P-gp inhibitors or substrates (e.g. cyclosporine, digoxin),
    6. polypeptide 6 (CYP2D6) substrates (e.g. tricyclic antidepressants and antipsychotics),or
    7. simvastatin at doses > 20 mg/day.
  5. Have corrected QT interval (QTc)> 450 msec (male) or > 470 msec (female) on 12-lead electrocardiogram.
  6. Poorly controlled diabetes, hemoglobin A1c (Hgb A1C) >9 or random blood glucose >250mg/dL.
  7. Active or symptomatic viral hepatitis or chronic liver disease.
  8. Clinically significant heart disease as evidenced by:

    1. myocardial infarction, or
    2. arterial thrombotic events in the past 6 months,
    3. severe or unstable angina, or
    4. New York Heart Association Class III-IV heart disease or
    5. 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01992016
Other Study ID Numbers  ICMJE 13-1908.cc
NCI-2013-02000 ( Other Identifier: National Cancer Institute )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Colorado, Denver
Study Sponsor  ICMJE University of Colorado, Denver
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Elaine Lam, MD University of Colorado, Denver
PRS Account University of Colorado, Denver
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP