Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer

Overview

The skeleton is the most frequent organ of distal metastases in prostate cancer, often representing the only site of metastatic disease. Still, assessment of response and progression to therapies in bone metastases remains a major unmet need, to aid treatment switch decisions, detecting primary/secondary resistance and to optimize drug development. The currently used standard imaging techniques, computed tomography (CT) and bone scintigraphy (BS), do not depict the true extent of bone metastases and are suboptimal in capturing biological changes occurring in response to treatment. This results in treatment switch decisions too often being based on PSA changes, which is neither a surrogate of survival, nor an optimal response biomarker.Diffusion-weighted imaging (DWI) is a functional magnetic resonance imaging (MRI) technique that studies the movement of water molecules within a tissue and provides valuable information about the tissue microstructure and cellularity. Whole body MRI with DWI is highly accurate for bone metastases detection, outperforming the standard CT and BS and other imaging techniques when assessing bone metastases. The investigators hypothesise that DWI changes are a response biomarker in bone metastases from metastatic castration resistant prostate cancer (mCRPC); these DWI changes can be detected as early as after 4 weeks of systemic treatment.

Full Title of Study: “A Study to Clinically Qualify Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) in Patients With Metastatic Castration Resistant Prostate Carcinoma With Bone Metastases”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: September 1, 2022

Interventions

  • Diagnostic Test: Whole-Body Diffusion Weighted MRI
    • MRI at baseline, after four and eight weeks of treatment and at disease progression or treatment discontinuation.

Arms, Groups and Cohorts

  • Other: Metastatic prostate cancer
    • Patients will receive whole-body MRI with diffusion-weighted imaging at baseline and after 4 and 8 weeks of treatment.

Clinical Trial Outcome Measures

Primary Measures

  • Changes in diffusion-weighted MRI as response biomarker
    • Time Frame: 8 weeks after treatment
    • Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases

Secondary Measures

  • Early response biomarker identification
    • Time Frame: 4 weeks after treatment
    • Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases
  • Intra-tumor heterogenous response evaluation
    • Time Frame: 4 and 8 weeks after treatment and at disease progression by standard criteria, on average 1 year
    • To use diffusion-weighted MRI for identifying anatomic regions of subclonal resistance to systemic treatment and study tumour evolution.

Participating in This Clinical Trial

Inclusion Criteria

  • Men 18 or over years old. – Patients with castration resistant prostate cancer. – Evidence of bone metastases by any imaging technique. – Patients due to start treatment with abiraterone or enzalutamide. In the exploratory cohorts, we will include patients due to start treatment with other systemic therapies for advanced prostate cancer (A-taxanes, B-radiopharmaceuticals, C-other therapies). – Written (signed and dated) informed consent. Exclusion Criteria:

  • Contraindications to MRI. – Inability of patient to tolerate whole body MRI (e.g. claustrophobia). – Patients who have received radiotherapy within the last three months and with no bone metastases outside the radiotherapy field.

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vall d’Hebron Institute of Oncology
  • Collaborator
    • Prostate Cancer Foundation
  • Provider of Information About this Clinical Study
    • Sponsor

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