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

October 13, 2021 updated by: Vall d'Hebron Institute of Oncology

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Vall d'Hebron Institute of Oncology
        • Contact:
          • Raquel Perez-Lopez, MD, PhD
          • Phone Number: 8682 +34 932543450
          • Email: rperez@vhio.net
        • Sub-Investigator:
          • Joan Carles, MD
        • Sub-Investigator:
          • Joaquin Mateo, MD, PhD
        • Sub-Investigator:
          • Rafael Morales, MD
        • Sub-Investigator:
          • Cristina Suarez, MD
        • Sub-Investigator:
          • Alonso Garcia, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Metastatic prostate cancer
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
MRI at baseline, after four and eight weeks of treatment and at disease progression or treatment discontinuation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 weeks after treatment
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.
4 and 8 weeks after treatment and at disease progression by standard criteria, on average 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vall d'Hebron Institute of Oncology

Collaborators

Prostate Cancer Foundation
Instituto de Salud Carlos III
Hospital Vall d'Hebron
Fundacio Puigvert

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

September 1, 2022

Study Completion (Anticipated)

September 1, 2023

Study Registration Dates

First Submitted

September 28, 2021

First Submitted That Met QC Criteria

October 13, 2021

First Posted (Actual)

October 14, 2021

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ipromet21

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer Metastatic

Clinical Trials on Whole-Body Diffusion Weighted MRI

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe