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Integrated whole body PET-MR or PET-CT and separate whole body MRI with use of 18F-FCH as the molecular probe

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)

Fluorocholine (18F-FCH) Injection

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

PET scan

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

Whole body MRI

Ur Metser, MD

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.

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.

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

18F-FCH-PET/MR in Staging of High-Risk Prostate Cancer: A Multiparametric Approach

Prostate Cancer Canada

University Health Network, Toronto

Antineoplastic Agents

All Drugs and Chemicals

Docetaxel

Patients who will be receiving Docetaxel as cancer treatment will be assigned to Arm 1. All patients in this cohort will have a \[F-18\]-FCH PET scan with full body MRI scan

Patients who will be receiving Abiraterone as cancer treatment will be assigned to Arm 2. All patients in this cohort will have a \[F-18\]-FCH PET scan with full body MRI scan.

Before the PET/MRI or PET/CT scan, patients will receive an \[F-18\]-Fluorocholine injection in the arm.

[F-18]-FCH

A whole body PET scan will be performed, combined with either whole body MRI or CT scan. This will be performed at baseline and after 12 weeks of treatment

Whole body MRI scan will be performed. This may be combined with PET scan or may be performed separately. MRI scan will be done at baseline and after 12 weeks of treatment

MRI scan

Eric Winquist, MD

Evaluate the ability of 18F-FCH PET/MRI scan to detect pre-treatment tumor burden and assess response to treatment in men with castration resistant prostate cancer (CRPC).

It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack thereof) earlier in the treatment period, providing a better guide for treating men with CRPC.

Castrate resistant prostate cancer (CRPC) occurs when prostate cancer no longer responds to androgen deprivation therapy. Eventually all men diagnosed with CRPC will succumb to their disease. While many new therapies have been introduced, there are limitations in assessing treatment response and physicians are faced with a challenge when creating a management strategy for men with CRPC.

Most men present with bone metastases, and accurate quantification of disease burden can be difficult due to the nature of conventional scans such as CT and bone scan. In addition, the standard blood PSA measurement does not always reflect a clinical response, or may lag to show this response. There is a clear need for better imaging and blood biomarkers to measure disease in men with CRPC.

This study will explore the benefit of a 18F-FCH Hybrid PET/MRI scan, Cancer Microparticle (CMP) and Circulating Tumor Cell (CTC) measurements compared to standard imaging and PSA levels.

In this study, patients will receive a 18F-FCH PET/MRI or 18F-FCH PET/CT scan + whole body MRI at baseline and after 12 weeks of treatment. Serial CMP and CTC blood samples will be taken at 5 study timepoints.

66 patients will be enrolled at 3 cancer centres in Ontario. Patients will be divided into 2 cohorts based on the type of treatment they will receive: Docetaxel or Abiraterone.

It is hypothesized that these novel biomarkers will better identify evaluable lesions prior to therapy and identify response to treatment (or lack thereof) earlier in the treatment period thus providing a better guide for treating men with CRPC.

18F-FCH PET/MRI to Assess Tumor Response in Castration Resistant Prostate Cancer

Assessment of CRPC Response Through Comprehensive Characterization Using Novel Biomarkers (PET CRPC)

At both baseline and after 12 weeks of treatment

As detected by 18F-FCH PET/MRI and change in CTC and CMP values

Changes in lesion parameters on PET and MRI and changes in serial CTC and CMP levels will be assessed to see if they are predictive of progression free survival

Changes in lesion parameters on PET and MRI and changes in serial CTC and CMP levels will be assessed to see if they are predictive of overall survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
18F-FCH (Fluorocholine)-PET/MR in Staging of High-Risk Prostate Cancer	NCT01993160	Prostate Cancer	Fluorocholine (... PET scan Whole body MRI	18 Years - 99 Years	University Health Network, Toronto
18F-FCH PET/MRI to Assess Tumor Response in Castration Resistant Prostate Cancer	NCT02121600	Prostate Cancer	[F-18]-FCH PET scan MRI scan	18 Years -	Lawson Health Research Institute

Spots Global Cancer Trial Database for fluorocholine (fch)