An observational study in Cancer and Urology, sponsored by The Clatterbridge Cancer Centre NHS Foundation Trust. Not yet recruiting at 1 site in United Kingdom. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by The Clatterbridge Cancer Centre NHS Foundation Trust · Observational
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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 40 is below the median of 200 across 2,638 observational studies indexed under Neoplasms.
Browse Neoplasms studies →The Clatterbridge Cancer Centre NHS Foundation Trust is the lead sponsor of 19 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Men with metastatic prostate cancer.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Group 1-3:
Group 1:
Group 4
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Newly diagnosed patients with visceral, with up to five bone metastasis. Treated with hormone therapy and darolutamide.
Newly diagnised patients with high volume bone metastasis, treated with hormone therapy and darolutimide .
Newly diagnosed patients, any site treated with hormone therapy, darolutimide and doctaxel (triple therapy).
Patients with disease progression and on any novel hormone therapy (PSA and/or imaging). Clinical management will be of a discretion of the clinician.
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.
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Sep 2026; primary completion for Sep 2029, 36 months later.
Of 1,098 non-industry observational studies under Neoplasms, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 227. This study's planned 36 months is below that.
Counting every sponsor, half of 1,246 studies reached it within 58 months; a quarter within 24 and three quarters within 210.
Neoplasms covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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The Clatterbridge Cancer Centre NHS Foundation Trust