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

NCT05078151 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2021-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Prostate Cancer Metastatic

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.

Sponsors & Collaborators

  • Prostate Cancer Foundation

    collaborator OTHER

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Fundacio Puigvert

    collaborator OTHER

  • Vall d'Hebron Institute of Oncology

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-09-01
Primary Completion
2022-09-01
Completion
2023-09-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05078151 on ClinicalTrials.gov