Adenocarcinoma of the ProstateNCT01992016
A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine
A study testing Ranolazine in people with Adenocarcinoma of the Prostate and Bone Metastases, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older, men only
- Conditions the study is for
- Adenocarcinoma of the Prostate, Bone Metastases, Soft Tissue Metastases
- What is being tested?
- Ranolazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2014to 11 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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),
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- 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:
- 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%.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Cancer Center
Aurora, Colorado, 80045
About this study
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.
Read the 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.
- Conditions
- Adenocarcinoma of the Prostate, Bone Metastases, Soft Tissue Metastases, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Being tested
- Ranolazine
- Keywords
- Prostate cancer, F18 FDG-PET, Imaging, Ranolazine, Bone metastases, Soft tissue metastases
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RanolazineDrug
Also called Ranexa
1000mg given orally twice daily for 1 day (2 doses).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Ranolazine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Increase in SUV Uptake
Number of participants who had increased SUV uptake, as defined by any of the following:
- SUVmax increase of 30% with a 2 unit absolute change.
- SUVmean increase of 30% with a 0.75 unit absolute change.
- SUVmean increase of 20% with a 1 unit absolute change.
Measured: Within 1 week after completion of ranolazine treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study start7 Apr 2014
- Primary completion8 Oct 2016
- Study completion11 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adenocarcinoma of the ProstateStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elaine Lam, MD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992016
- Sponsor's protocol ID
- 13-1908.cc
- Other IDs
- NCI-2013-02000
- Status last verified
- Nov 2018
- First submitted
- 12 Nov 2013
- Last updated
- 3 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Enhance F18 FDG-PET Imaging of Prostate Cancers With the Metabolic Inhibitor Ranolazine
- ClinicalTrials.gov ID
- NCT01992016
- Acronym / sponsor ID
- 13-1908.cc
- Conditions
- Adenocarcinoma of the Prostate, Bone Metastases, Soft Tissue Metastases, Stage IIA Prostate Cancer, Stage IIB Prostate Cancer, Stage III Prostate Cancer
- Keywords
- Prostate cancer, F18 FDG-PET, Imaging, Ranolazine, Bone metastases, Soft tissue metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 7 Apr 2014 (actual)
- Primary completion
- 8 Oct 2016 (actual)
- Study completion
- 11 Apr 2018 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Posted 4 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (localized prostate cancer) | Experimental | Drug: RanolazinePatients 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. |
| Arm II (metastatic prostate cancer) | Experimental | Drug: RanolazinePatients receive ranolazine PO BID for 1 day. Patients undergo FDG-PET/CT scan at baseline and after ranolazine treatment. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (27 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RanolazineAlso: Ranexa1000mg given orally twice daily for 1 day (2 doses). | Drug | Arm I (localized prostate cancer), Arm II (metastatic prostate cancer) |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elaine Lam, MD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ranolazine in people with Adenocarcinoma of the Prostate and Bone Metastases, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Increase in SUV Uptake (time frame: Within 1 week after completion of ranolazine treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2018.