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

NCT01992016 | Completed Results DMC

• 2 other identifiers: 13-1908.ccNCI-2013-02000
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Prostate cancer; F18 FDG-PET; Imaging; Ranolazine; Bone metastases; Soft tissue metastases

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Increase in SUV Uptake

  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.

  Within 1 week after completion of ranolazine treatment

Study Arms (2)

Arm I (localized prostate cancer)

EXPERIMENTAL

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.

Drug: Ranolazine

Arm II (metastatic prostate cancer)

EXPERIMENTAL

Patients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment.

Drug: Ranolazine

Interventions

Ranolazine DRUG

1000mg given orally twice daily for 1 day (2 doses).

Also known as: Ranexa

Arm I (localized prostate cancer); Arm II (metastatic prostate cancer)

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent has been obtained.
• Adults over 18 years of age.
• Histological or cytologically confirmed prostate adenocarcinoma.
• 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.
• 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.
• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Fasting blood glucose ≤ 120 mg/dL.
• Adequate renal function (Creatinine ≤ 1.5 X ULN)
• 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.
• Must be able to take oral medication without crushing, dissolving or chewing tablets.
• Written authorization for use and release of health and research study information has been obtained.
• 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.

You may not qualify if:

• 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:
• 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.
• 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:

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Cancer Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Ranolazine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Elaine Lam, MD
• Organization: University of Colorado Cancer Center

elaine.lam@ucdenver.edu

7208480273

Study Officials

• Elaine Lam, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 25, 2013
• Study Start: April 7, 2014
• Primary Completion: October 8, 2016
• Study Completion: April 11, 2018
• Last Updated: December 3, 2018
• Results First Posted: June 4, 2018

Record last verified: 2018-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)