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.
- Male 18 years of age or older
Diagnosis of metastatic adenocarcinoma of the prostate (either histologically confirmed or PSA >100 and multiple bone metastasis and or abnormal MRI prostate compatible with metastatic prostate cancer)
Previous radical prostatectomy or radical radiotherapy is allowed
Bisphosphonate therapy (any type) is allowed but needs to be continued throughout the time on study
- Non-metastatic prostate cancer (i.e. patients with only prostate and regional lymph node involvement are not eligible).
Patients who have been >3 months on ADT (aLHRH (any type) or LHRH (any type) ) at screening are not eligible
Group 1-3 already commenced abiraterone, apalutamide, darolutamide or enzalutamide
Group 1-3 already commenced docetaxel for mHSPC
Men with metastatic prostate cancer.
Cohort
Prospective
Not listed
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
Exploratory Metabolic, clinical and survival outcomes.
Characterisation of UMMs on first, second and further line therapies.
Targeted mining of data
Targeted and un-targeted mining of data for a panel for newly identified markers of bone collagen breakdown.
Metabolite identification
Progressive or response for identification of potential metabolite and metabolic pathway changes.
Correlation of profiles
Correlation of the UMM profiles with PSA, alkaline phosphates, clinical data and the volume of disease on CT scan.
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This trial is not recruiting at the moment. You can still explore other options:
