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

NCT05078151 | Unknown

• 1 other identifier: ipromet21
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

response biomarker; functional imaging; MRI

Outcome Measures

Primary Outcomes (1)

• Changes in diffusion-weighted MRI as response biomarker

  Apparent Diffusion Coefficient (ADC) percentage change in responders vs non-responders to systemic treatment in patients with CRPC and bone metastases

  8 weeks after treatment

Secondary Outcomes (2)

• Early response biomarker identification

  4 weeks after treatment

• Intra-tumor heterogenous response evaluation

  4 and 8 weeks after treatment and at disease progression by standard criteria, on average 1 year

Study Arms (1)

Metastatic prostate cancer

OTHER

Patients will receive whole-body MRI with diffusion-weighted imaging at baseline and after 4 and 8 weeks of treatment.

Diagnostic Test: Whole-Body Diffusion Weighted MRI

Interventions

Whole-Body Diffusion Weighted MRI DIAGNOSTIC_TEST

MRI at baseline, after four and eight weeks of treatment and at disease progression or treatment discontinuation.

Metastatic prostate cancer

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vall d'Hebron Institute of Oncology: lead
• Prostate Cancer Foundation: collaborator
• Instituto de Salud Carlos III: collaborator
• Hospital Vall d'Hebron: collaborator
• Fundacio Puigvert: collaborator

Study Sites (1)

Vall d'Hebron Institute of Oncology

Barcelona, 08035, Spain

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 14, 2021
• Study Start: September 1, 2018
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2023
• Last Updated: October 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)