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

NCT02121600 | Terminated DMC

• 1 other identifier: PET CRPC
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Number of lesions detected with 18F-FCH PET/MRI compared to conventional imaging

  3 years

Secondary Outcomes (5)

• 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

  3 years

• Change in number and size of lesions after 12 weeks of treatment

  3 years

• Progression Free Survival

  6 years

• Overall Survival

  6 years

Other Outcomes (3)

• 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

Study Arms (2)

Docetaxel

OTHER

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; Radiation: PET scan; Radiation: MRI scan

Abiraterone

OTHER

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; Radiation: PET scan; Radiation: MRI scan

Interventions

[F-18]-FCH OTHER

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

Also known as: [F-18]-Fluorocholine Injection

Abiraterone; Docetaxel

PET scan RADIATION

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

Abiraterone; Docetaxel

MRI scan RADIATION

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; Docetaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Ontario Institute for Cancer Research: collaborator

Study Sites (3)

Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 4L6, Canada

Location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Eric Winquist, MD

  London Health Sciences Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: April 23, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: May 7, 2019

Record last verified: 2019-05

Locations

CA (3)