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

NCT ID: NCT01993160

Last Updated: 2017-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Fluorocholine (18F-FCH) Injection

Intervention Type: DRUG

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 scan

Intervention Type: RADIATION

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

Whole body MRI

Intervention Type: RADIATION

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

Interventions

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)

Intervention Type: DRUG

PET scan

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

Intervention Type: RADIATION

Whole body MRI

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

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Prostate Cancer Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ur Metser, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Princess Margaret Cancer Centre, University Health Network, 610 University Ave.

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

18F-FCH-PET/MR

Identifier Type: -

Identifier Source: org_study_id