Clinical trial NCT01993160: 18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer
Official title: 18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Fluorocholine (FCH)
Positron emission tomography (PET)
Magnetic resonance imaging (MRI)
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Canada
First posted: 2013-11-25
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of prostate cancer foci detected with FCH PET/MR compared to MR alone.
timeFrame: 2 years
Secondary outcomes:
measure: 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).
timeFrame: 2 years
Other outcomes:
measure: 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.
timeFrame: 2 years
measure: 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.
timeFrame: 2 years
Locations:
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre, University Health Network, 610 University Ave.
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Ur Metser, MD
role: PRINCIPAL_INVESTIGATOR
References: