Prostate CancerNCT01993160
18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer
A study testing Fluorocholine (18F-FCH) Injection, PET scan and Whole body MRI in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging patients with high risk prostate cancer. Study Hypothesis: FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Fluorocholine (18F-FCH) Injection, PET scan and Whole body MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Histologic diagnosis of carcinoma of prostate
- High risk disease: defined as Gleason ≥8, or T3 disease, or PSA >20ng/mL
- No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy).
- Ability to provide written informed consent to participate in the study
Who cannot join
- Prior surgery or radiation therapy for prostate cancer
- Prior or ongoing hormone or other systemic therapy for prostate cancer
- Inability to lie supine for 90 minutes
- Any contraindication to MR as per Joint Department of Medical Imaging policies.
- Impaired kidney function with glomerular filtration rate < 30ml/min
- Previous anaphylactic reaction to gadolinium or other contraindications to MR.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
Toronto, Ontario, M5G 2M9
About this study
Official title: 18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach
This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging patients with high risk prostate cancer.
Study Hypothesis:
FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging.
Read the detailed description
Up to 60% of patients treated with radical prostatectomy or external beam radiotherapy for prostate cancer will have biochemical failure at 5 years. This may be due to several reasons, including presence of sub-clinical metastases at time of local therapy.
Currently, patients with high risk prostate cancer are staged by MRI of the prostate (to assess local extent of disease), CT of the abdomen(to detect spread to lymph nodes) and bone scan (to assess for spread to bones). However, these standard imaging exams do not always identify all sites of disease. Recent research has suggested that performing positron emission tomography (PET) scanning with a tracer called fluorocholine (FCH) improves identification of lymph node and bone metastases in prostate cancer, resulting in more accurate diagnosis.
The main goal of this study is to find out whether staging high risk prostate cancer patients with FCH PET-CT and MRI of the whole body will improve detection of primary tumors and metastases compared to current standard imaging exams. Improved staging of patients with prostate cancer may impact patient care as it will help to select more appropriate therapy.
In this study, participants will undergo either combined PET/MRI or PET-CT and MRI after standard evaluations. The accuracy of each staging approach (standard vs. PET and MRI) will be evaluated. In addition, we will incorporate novel methods for data interpretation by creating imaging maps combining data from PET and MRI (termed "Multiparametric maps"). The goal of this novel approach is to find out whether mapping 2 or more characteristics of a tumor at the same time will improve tumor detection and accuracy of diagnosis.
About 40 men from the Princess Margaret Hospital will take part in this study. The study should take about 2 years to complete enrollment and the results should be known within 36 months of completion of enrollment.
- Conditions
- Prostate Cancer
- Being tested
- Fluorocholine (18F-FCH) Injection, PET scan, Whole body MRI
- Keywords
- Fluorocholine (FCH), Positron emission tomography (PET), Magnetic resonance imaging (MRI)
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorocholine (18F-FCH) InjectionDrug
Before the PET-CT scan, the tracer (fluorocholine/FCH) will be injected into a vein in your arm just before the scan. This is the agent we are investigating in this study (not part of the standard procedure)
PET scanRadiation
A whole body PET scan will be performed, integrated with either whole body low dose CT or whole body MRI
Whole body MRIRadiation
A whole body MRI scan will be performed. This may be integrated with PET scan or performed separately.
| Study group | Role | What they receive |
|---|---|---|
| 18F-FCH PET MR | Experimental | Integrated whole body PET-MR or PET-CT and separate whole body MRI with use of 18F-FCH as the molecular probe Receives: Drug: Fluorocholine (18F-FCH) Injection; Radiation: PET scan; Radiation: Whole body MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of prostate cancer foci detected with FCH PET/MR compared to MR alone.
Measured: 2 years
Secondary outcomes (1)
Detection rate of lymph node and distant metastases in patients with high risk prostate cancer as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
Measured: 2 years
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 startDec 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Prostate Cancer Canada
- Responsible party
- Sponsor
- Investigators
- Ur Metser, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993160
- Sponsor's protocol ID
- 18F-FCH-PET/MR
- Status last verified
- Jan 2017
- First submitted
- 25 Oct 2013
- Last updated
- 13 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach
- ClinicalTrials.gov ID
- NCT01993160
- Acronym / sponsor ID
- 18F-FCH-PET/MR
- Conditions
- Prostate Cancer
- Keywords
- Fluorocholine (FCH), Positron emission tomography (PET), Magnetic resonance imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Prostate Cancer Canada
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single centre, single arm feasibility study of 18FCH PET-MR imaging for staging patients with high risk prostate cancer.
Study Hypothesis:
FCH-PET/MR will enable more accurate staging of patients with high risk prostate cancer as compared to conventional imaging.
Detailed description
Up to 60% of patients treated with radical prostatectomy or external beam radiotherapy for prostate cancer will have biochemical failure at 5 years. This may be due to several reasons, including presence of sub-clinical metastases at time of local therapy.
Currently, patients with high risk prostate cancer are staged by MRI of the prostate (to assess local extent of disease), CT of the abdomen(to detect spread to lymph nodes) and bone scan (to assess for spread to bones). However, these standard imaging exams do not always identify all sites of disease. Recent research has suggested that performing positron emission tomography (PET) scanning with a tracer called fluorocholine (FCH) improves identification of lymph node and bone metastases in prostate cancer, resulting in more accurate diagnosis.
The main goal of this study is to find out whether staging high risk prostate cancer patients with FCH PET-CT and MRI of the whole body will improve detection of primary tumors and metastases compared to current standard imaging exams. Improved staging of patients with prostate cancer may impact patient care as it will help to select more appropriate therapy.
In this study, participants will undergo either combined PET/MRI or PET-CT and MRI after standard evaluations. The accuracy of each staging approach (standard vs. PET and MRI) will be evaluated. In addition, we will incorporate novel methods for data interpretation by creating imaging maps combining data from PET and MRI (termed "Multiparametric maps"). The goal of this novel approach is to find out whether mapping 2 or more characteristics of a tumor at the same time will improve tumor detection and accuracy of diagnosis.
About 40 men from the Princess Margaret Hospital will take part in this study. The study should take about 2 years to complete enrollment and the results should be known within 36 months of completion of enrollment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FCH PET MR | Experimental | Drug: Fluorocholine (18F-FCH) Injection, Radiation: PET scan, Radiation: Whole body MRIIntegrated whole body PET-MR or PET-CT and separate whole body MRI with use of 18F-FCH as the molecular probe |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Histologic diagnosis of carcinoma of prostate
- High risk disease: defined as Gleason ≥8, or T3 disease, or PSA >20ng/mL
- No prior therapy for prostate cancer (surgery, radiation therapy, hormone therapy, chemotherapy).
- Ability to provide written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Prior surgery or radiation therapy for prostate cancer
- Prior or ongoing hormone or other systemic therapy for prostate cancer
- Inability to lie supine for 90 minutes
- Any contraindication to MR as per Joint Department of Medical Imaging policies.
- Impaired kidney function with glomerular filtration rate < 30ml/min
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 |
|---|---|---|
| Fluorocholine (18F-FCH) InjectionBefore the PET-CT scan, the tracer (fluorocholine/FCH) will be injected into a vein in your arm just before the scan. This is the agent we are investigating in this study (not part of the standard procedure) | Drug | 18F-FCH PET MR |
| PET scanA whole body PET scan will be performed, integrated with either whole body low dose CT or whole body MRI | Radiation | 18F-FCH PET MR |
| Whole body MRIA whole body MRI scan will be performed. This may be integrated with PET scan or performed separately. | Radiation | 18F-FCH PET MR |
Primary outcome
Number of prostate cancer foci detected with FCH PET/MR compared to MR alone.
Time frame: 2 years
1 secondary outcome
Detection rate of lymph node and distant metastases in patients with high risk prostate cancer as compared to conventional imaging strategies (CT abdomen and bone scintigraphy).
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2017.
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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.
Ur Metser, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluorocholine (18F-FCH) Injection, PET scan and Whole body MRI in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 6 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 13 Jan 2017. 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 prostate cancer foci detected with FCH PET/MR compared to MR alone. (time frame: 2 years). 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 13 Jan 2017.