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18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer

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. Identifier: NCT01993160
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : January 13, 2017
Prostate Cancer Canada
Information provided by (Responsible Party):
University Health Network, Toronto

Brief 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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: Fluorocholine (18F-FCH) Injection Radiation: PET scan Radiation: Whole body MRI Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach
Study Start Date : December 2013
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 18F-FCH PET MR
Integrated whole body PET-MR or PET-CT and separate whole body MRI with use of 18F-FCH as the molecular probe
Drug: Fluorocholine (18F-FCH) Injection
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)

Radiation: PET scan
A whole body PET scan will be performed, integrated with either whole body low dose CT or whole body MRI

Radiation: Whole body MRI
A whole body MRI scan will be performed. This may be integrated with PET scan or performed separately.

Primary Outcome Measures :
  1. Number of prostate cancer foci detected with FCH PET/MR compared to MR alone. [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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). [ Time Frame: 2 years ]

Other Outcome Measures:
  1. Overall accuracy of multiparametric mapping of choline metabolism with various MR parameters in staging of patients with high risk prostate cancer as compared to conventional imaging strategies. [ Time Frame: 2 years ]
  2. Relationship of choline kinase activity in the primary tumor (as expressed by FCH uptake) to presence of hypoxia and expression of GLUT-1 transporter proteins in pathology specimens. [ Time Frame: 2 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01993160

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Canada, Ontario
Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Prostate Cancer Canada
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Principal Investigator: Ur Metser, MD University Health Network, Toronto
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Responsible Party: University Health Network, Toronto Identifier: NCT01993160    
Other Study ID Numbers: 18F-FCH-PET/MR
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: January 13, 2017
Last Verified: January 2017
Keywords provided by University Health Network, Toronto:
Fluorocholine (FCH)
Positron emission tomography (PET)
Magnetic resonance imaging (MRI)
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases