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)

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.

Study Overview

• Status: Terminated
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: [F-18]-FCH; Radiation: PET scan; Radiation: MRI scan

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8V 5C2
      • Juravinski Cancer Centre
    • London, Ontario, Canada, N6A 4L6
      • London Regional Cancer Program
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• 18 years of age or older
• Patient with CRPC and experiencing disease progression as defined by PCWG2
• ECOG 0-2
• Must continue gonadal castrative therapy
• Has completed antiandrogen withdrawal ≥ 6 weeks prior to registration
• Metastatic disease documented by imaging
• Patient is planned for treatment with docetaxel or abiraterone
• If treated with bisphosphonates or denosumab, has been on these for ≥ 6 weeks.
• Must provide written informed consent

Exclusion Criteria:

• Prior history of invasive malignant disease unless disease free for at least 5 years, with the exception of non-melanoma skin cancer
• Planned for any concurrent anticancer treatment oher than docetaxel or abiraterone
• Prior radiotherapy or surgery within 4 weeks of start of docetaxel or abiraterone
• Inability to comply with the imaging requirements (eg. inability to lie supine for one hour)
• Allergy to MRI contrast agent or PET tracer to be used as part of the imaging
• Sickle cell disease or other hemoglobinopathies
• Insufficient renal function (eGFR ≤ 30 mL/min)
• Known residual bladder volume > 150 cc
• Hip prosthesis or intrabdominal vascular grafting
• Contraindication to CT contrast
• Contraindication to MRI as per institutional policy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Other: [F-18]-FCH; Before the PET/MRI or PET/CT scan, patients will receive an [F-18]-Fluorocholine injection in the arm.; Other Names: [F-18]-Fluorocholine Injection; Radiation: PET scan; 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; Radiation: MRI scan; 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
Other: Abiraterone; 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.	Other: [F-18]-FCH; Before the PET/MRI or PET/CT scan, patients will receive an [F-18]-Fluorocholine injection in the arm.; Other Names: [F-18]-Fluorocholine Injection; Radiation: PET scan; 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; Radiation: MRI scan; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of lesions detected with 18F-FCH PET/MRI compared to conventional imaging	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of concordant lesions identified on identified on 18F-FCH PET, conventional imaging and MRI		3 years
Concordance between number Circulating Tumor Cells (CTCs) and Cancer Microparticles (CMPs) and number of lesions detected by PET/MRI and conventional imaging	At both baseline and after 12 weeks of treatment	3 years
Change in number and size of lesions after 12 weeks of treatment	As detected by 18F-FCH PET/MRI and change in CTC and CMP values	3 years
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 progression free survival	6 years
Overall 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	6 years

Other Outcome Measures

Outcome Measure	Time Frame
Percentage of change in clinical management based on results of 18F-FCH PET/MRI and CTC results	3 years
Concordance of identified lesions on hybrid PET/CT + fused MRI vs hybrid PET/MRI	3 years
Concordance between CTC values on a new microfluidics-based CTC assay and the FDA/Health Canada approved CellSearch CTC assay (clinical gold standard)	3 years

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute
• Collaborators: OICR
• Investigators: Principal Investigator: Eric Winquist, MD, London Health Sciences Centre

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 22, 2014
• First Posted (Estimate): April 23, 2014

Study Record Updates

• Last Update Posted (Actual): May 7, 2019
• Last Update Submitted That Met QC Criteria: May 3, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Keywords: Positron Emission Tomography (PET); Magnetic Resonance Imaging (MRI); Fluorocholine (FCH)
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PET CRPC