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

• ClinicalTrials.gov Identifier: NCT02121600
• Recruitment Status: Terminated
• First Posted: April 23, 2014
• Last Update Posted: May 7, 2019
• Sponsor: Lawson Health Research Institute
• Collaborator: OICR
• Information provided by (Responsible Party): Lawson Health Research Institute

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Prostate Cancer	Other: [F-18]-FCH; Radiation: PET scan; Radiation: MRI scan	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 5 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Assessment of CRPC Response Through Comprehensive Characterization Using Novel Biomarkers (PET CRPC)
• Study Start Date: September 2014
• Actual Primary Completion Date: December 2017
• Actual Study Completion Date: March 2018

Arms and Interventions

Arm	Intervention/treatment
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 Name: [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
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 Name: [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

Outcome Measures

Primary Outcome Measures :

1. Number of lesions detected with 18F-FCH PET/MRI compared to conventional imaging [ Time Frame: 3 years ]

Secondary Outcome Measures :

1. Number of concordant lesions identified on identified on 18F-FCH PET, conventional imaging and MRI [ Time Frame: 3 years ]
2. Concordance between number Circulating Tumor Cells (CTCs) and Cancer Microparticles (CMPs) and number of lesions detected by PET/MRI and conventional imaging [ Time Frame: 3 years ]
   At both baseline and after 12 weeks of treatment
3. Change in number and size of lesions after 12 weeks of treatment [ Time Frame: 3 years ]
   As detected by 18F-FCH PET/MRI and change in CTC and CMP values
4. Progression Free Survival [ Time Frame: 6 years ]
   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
5. Overall Survival [ Time Frame: 6 years ]
   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

Other Outcome Measures:

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

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

Canada, Ontario

Juravinski Cancer Centre

Hamilton, Ontario, Canada, L8V 5C2

London Regional Cancer Program

London, Ontario, Canada, N6A 4L6

Princess Margaret Cancer Centre

Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

Lawson Health Research Institute

OICR

Investigators

• Principal Investigator: Eric Winquist, MD; London Health Sciences Centre

More Information

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT02121600
• Other Study ID Numbers: PET CRPC
• First Posted: April 23, 2014
• Last Update Posted: May 7, 2019
• Last Verified: May 2019

Keywords provided by Lawson Health Research Institute:

Fluorocholine (FCH); Positron Emission Tomography (PET); Magnetic Resonance Imaging (MRI)

Additional relevant MeSH terms:

Prostatic Neoplasms; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases