Clinical trial NCT05078151: Whole-Body Diffusion-Weighted Magnetic Resonance Imaging (MRI) as a Response Biomarker for Metastatic Prostate Cancer
Official title: 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: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer Metastatic
Keywords: response biomarker
functional imaging
MRI
Lead sponsor: Vall d'Hebron Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Prostate Cancer Foundation
name: Instituto de Salud Carlos III
name: Hospital Vall d'Hebron
name: Fundacio Puigvert
First posted: 2021-10-14
Enrollment: 69
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Changes in diffusion-weighted MRI as response biomarker
timeFrame: 8 weeks after treatment
Secondary outcomes:
measure: Early response biomarker identification
timeFrame: 4 weeks after treatment
measure: Intra-tumor heterogenous response evaluation
timeFrame: 4 and 8 weeks after treatment and at disease progression by standard criteria, on average 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d'Hebron Institute of Oncology
Study officials:
References: