Clinical trial NCT02121600: 18F-FCH PET/MRI to Assess Tumor Response in Castration Resistant Prostate Cancer
Official title: Assessment of CRPC Response Through Comprehensive Characterization Using Novel Biomarkers (PET CRPC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Prostate Cancer
Keywords: Fluorocholine (FCH)
Positron Emission Tomography (PET)
Magnetic Resonance Imaging (MRI)
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Ontario Institute for Cancer Research
First posted: 2014-04-23
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of lesions detected with 18F-FCH PET/MRI compared to conventional imaging
timeFrame: 3 years
Secondary outcomes:
measure: Number of concordant lesions identified on identified on 18F-FCH PET, conventional imaging and MRI
timeFrame: 3 years
measure: Concordance between number Circulating Tumor Cells (CTCs) and Cancer Microparticles (CMPs) and number of lesions detected by PET/MRI and conventional imaging
timeFrame: 3 years
measure: Change in number and size of lesions after 12 weeks of treatment
timeFrame: 3 years
measure: Progression Free Survival
timeFrame: 6 years
measure: Overall Survival
timeFrame: 6 years
Other outcomes:
measure: Percentage of change in clinical management based on results of 18F-FCH PET/MRI and CTC results
timeFrame: 3 years
measure: Concordance of identified lesions on hybrid PET/CT + fused MRI vs hybrid PET/MRI
timeFrame: 3 years
measure: Concordance between CTC values on a new microfluidics-based CTC assay and the FDA/Health Canada approved CellSearch CTC assay (clinical gold standard)
timeFrame: 3 years
Locations:
city: Hamilton
country: Canada
facility: Juravinski Cancer Centre
state: Ontario
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Eric Winquist, MD
role: PRINCIPAL_INVESTIGATOR
References: