80% of patients with newly diagnosed metastatic hormone sensitive prostate cancer have bone metastases. There are mutations that are described with early disease progression when on hormone therapy for prostate cancer. In the NHS setting it is difficult to detect and monitor the patients. There are biochemical changes in the body that are associated with bone metastasis which can be detected in bodily fluids such as urine. Metabolites are substances involved in metabolism (= the chemical processes in the body needed for life. They are usually small molecules. Metabolomics is a way of studying the 'metabolome' which is the entire complement of small molecules present within the body. The metabolites are very sensitve to environmental or other changes and these can be markers for change caused by prostate cancer metastasis. Therefore the urinary metabolome is is potentially a very good indicator of change caused by cancer and hormone treatment. Accurate and specific urine tests would be a way to allow better monitoring of patients. This study aims to investigate the changes of specific bone urinary metabolome markers (UMMs) and untargeted urine profiles to detect the response and progression of patients with prostate cancer (PC). We propose that UMMs are simpler, less difficult for patients and more sensitive and specific compared to conventional imaging and routine blood tests, the current gold standard.
Study Type
OBSERVATIONAL
Enrollment
40
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, United Kingdom
Detect clinically significant differences
To characterise the UMMs of PC patients with or without high volume bone metastases and detect clinically significant differences between response and progression during 12 months
Time frame: Through study completion, average 1 year.
Exploratory Metabolic, clinical and survival outcomes.
Characterisation of UMMs on first, second and further line therapies.
Time frame: Through study completion, average 1 year.
Targeted mining of data
Targeted and un-targeted mining of data for a panel for newly identified markers of bone collagen breakdown.
Time frame: Through study completion, average of 1 year
Metabolite identification
Progressive or response for identification of potential metabolite and metabolic pathway changes.
Time frame: Through study completion, average 1 year
Correlation of profiles
Correlation of the UMM profiles with PSA, alkaline phosphates, clinical data and the volume of disease on CT scan.
Time frame: Through study completion, average 1 year.
Detection of early metabolite changes
Detection of early metabolite changes, associated with bone metastasis, some patients in group 1 will develop bone metastasis. We aim to capture early metabolite changes, that mark this initial progression.
Time frame: Through study completion, 1 year average.
Biochemical free survival
Biochemical progression free survival, defined as per PCWG3 definition (increase in PSA greater than 25% and \> 2 ng/mL above nadir, confirmed by 2 time points at least 3 weeks apart (ie, a confirmed rising trend)
Time frame: Through study completion, average 1 year.
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