Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer

Study Overview
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Brief Summary
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The aim of this study is to provide clinical evidence to determine if Whole Body Magnetic Resonance Imaging (WBMRI) with a novel technique called diffusion-weighted imaging (DWI) can improve current treatment for APC patients, allowing for early identification of disease progression or treatment response, hence facilitating clinical decision-making and leading to improvement in patient care. The IDT study includes two retrospective analyses and a single centre prospective observational study for APC patients.

Detailed Description
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Metastatic Advanced Prostate Cancer occurs when cancer spreads from the prostate to other parts of the body (bones, lymph nodes or other organs), with bones being the commonest site of spread in prostate cancer. These cancer growths are called metastases. APC metastases are diverse (heterogeneous) in their growth pattern, such that not all metastases will respond to the same treatment.

Official Title
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Improving Diagnosis and Treatment of Metastatic Advanced Prostate Cancer Through Better Imaging With Whole-Body Magnetic Resonance Imaging With Diffusion Weighted Imaging

Conditions
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Advanced Prostate Carcinoma

Intervention / Treatment
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* Diagnostic Test: Post-treatment CT-guided bone marrow biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Retrospective study A Baseline WBMRI scans in metastatic APC patients acquired up to 8 weeks prior to the initiation of a new line of therapy. Retrospective study B Paired WBMRI scans in metastatic APC patients at baseline within 8 weeks prior to treatment and at 12 ± 3 weeks after systemic treatment Prospective study C Written informed consent. Age ≥18 years. Advanced prostate cancer patients with indication for systemic anti-cancer therapy to be enrolled in a clinical study. Participants must have a baseline WBMRI and CT-guided bone marrow biopsy. Exclusion Criteria: Prospective Study C Patient is claustrophobic. Contraindications to MRI examination (e.g., cardiac pacemakers, cochlear implants).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Post-treatment CT-guided bone marrow biopsy|At post-treatment, 12 +/- 3 weeks after initiating treatment, patients will undergo a CT guided bone marrow biopsy of the same lesion as baseline.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective analysis: WBMRI parameters | Prognostic association of derived pre-treatment WBMRI parameters, total disease volume (tDV) and apparent diffusion coefficient (ADC) for prediction of overall survival. | Month 1-26 | 
| Retrospective analysis: Diagnostic performance of MET-RADS-P | Accuracy of MET-RADS-P to assess response to systemic treatment. | Month 1-26 | 
| Single centre prospective observational imaging study | Pairwise correlations of percentage of ADC change with: Tumour regression grading according to the international system of Salzer-Kuntschnik Changes in biopsy tumour content and tumour/necrosis ratio Fat fraction percentage with bone marrow adipose tissue/fibrosis reported by histopathology analysis. | Month 6-38 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retrospective analysis: WBMRI parameters | Prognostic association of baseline tDV and ADC for prediction of radiographic Progression Free Survival (rPFS) using Prostate Cancer Working Group 3 criteria (PCWG3) and Skeletal Related Events (SREs). | Month 1-26 | 
| Retrospective analysis: Diagnostic performance of MET-RADS-P | Inter-observer agreement - determine prognostic association of MET-RADS-P response for prediction of overall survival. | Month 1-26 | 
| Single centre prospective observational imaging study | Fraction of bone biopsies with sufficient tumour yield for genomic sequencing. | Month 6-38 |