Whole Body Magnetic Resonance Imaging Study
Whole Body Magnetic Resonance Imaging Study
In prostate cancer bone is the most common site for cancer spread, causing pain, fractures,
 nerve compression and death.

 New therapies are available for treating bone disease from cancer and this means that by
 maintaining patients on drugs that are effective and switching patients to other drugs when
 current treatment becomes ineffective, patients can be maintained 'better for longer'.
 However, to do this, it is necessary to accurately tell whether a given treatment is working
 or not.

 In this study, the investigators will perform whole body MRI scans, which include a special
 scan called diffusion-weighted MRI (DWI MRI) that can provide more information about the
 participants extent of disease. The investigators aim to show that this test is better than
 the standard tests of CT and bone scan currently used in the NHS to monitor bone disease. The
 information from this study will be used to test a special software so that the test may more
 widely benefit patients across the NHS in the future.
In patients with prostate cancer the current methods to assess treatment response of bone
 disease such as computer tomography (CT) and bone scan (BS)are unreliable, insensitive to
 bone disease and have limited criteria to assess disease response confined to bones. Blood
 tests are inaccurate although some newer tests (e.g. circulating tumour cells tests) show
 promise but are still under investigation and nuclear medicine investigations such as PET/CT
 imaging have higher sensitivity, meaning they can detect more sites of disease who are indeed
 disease than CT or BS but they are more costly and less widely available compared with MRI
 within the NHS.

 For this study the Whole body MRI (WB-MRI) includes a measurement called diffusion-weighted
 imaging (DWI) which is relatively new and has a high sensitivity for bone metastases. This
 technique can be used to measure total bone disease volume (TDV) and the disease apparent
 diffusion coefficient (ADC) which reflects the tumour tissue cell density. Previous studies
 have shown good reproducibility of both these measurements and a significant increase in the
 mean tumour ADC is observed in patients who are responding to effective treatment.

 However WB-MRI application across the NHS is ad-hoc, CT and BS techniques are entrenched
 within clinical practice despite their known limitations. Another factor that limits wider
 adoption of WB-MRI is the lack of sophisticated analysis software to enable disease across
 the body to be quickly evaluated.

 This multi-centre imaging study will provide the opportunity to evaluate the performance of
 WB-MRI with a novel software diagnostics for evaluating the treatment response of advanced
 prostate cancer patients.

 This prototype can used to evaluate WB-MRI data from different scanners and address a current
 major unmet need for the treatment and follow-up of patients with bone disease from cancers,
 so that the test may more widely benefit patients across the NHS in the future.
Inclusion Criteria:

 1. Written informed consent

 2. Age ≥18 years

 3. Patients with APC with predominantly bone disease confirmed by bone scan (within 6
 weeks) or CT (within 6 weeks), of starting treatment (Cycle 1 Day 1). Patients with
 local recurrence and bone metastases with an associated soft tissue component, will be
 allowed into the trial. Pelvic lymphadenopathy <1.5cm in short axis is not an
 exclusion.

 4. Systemic therapy indicated for disease progression, as clinically indicated.

 Exclusion Criteria:

 1. Patient is claustrophobic.

 2. Contraindications to MRI examination (e.g. cardiac pacemakers, cochlear implants).

 3. Measurable soft tissue or lymph node metastases or any metastatic disease outside the
 bone that is RECIST measurable will be an exclusion (unless it is pelvic nodal disease
 <1.5cm in short axis). Bone metastases with associated soft tissue components will
 also not be an exclusion.