Urine and Blood Markers to Track Treatment in Metastatic Prostate Cancer
Studies urine and blood markers to track hormone therapy in metastatic prostate cancer.
Plain-language title generated from the registry record
Registry title: Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.
Key facts
- Where
- Liverpool, United KingdomSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for men with prostate cancer that has spread. Some have hormone-sensitive disease and are about to start treatment. Others are already on a hormone medicine and their disease is getting worse.
- Age
- 18 years or older
- Sex
- Men only
- Disease stage
- Prostate cancer that has spread (metastatic). Groups 1-3: hormone sensitive disease, any local stage (T1-T4) and any pelvic lymph node involvement (N0-N1). Group 4: the disease is getting worse on PSA, imaging or both.
- Earlier treatment
- Groups 1-3: not yet started abiraterone, apalutamide, darolutamide, enzalutamide or docetaxel, and no more than 3 months of hormone treatment (ADT) at screening. Group 4: currently on abiraterone, apalutamide, darolutamide or enzalutamide. Earlier chemotherapy is allowed but not required. Earlier prostate surgery or radiotherapy is allowed.
- Biomarker or test result
- Prostate cancer confirmed under the microscope, or PSA above 100 with several bone metastases, or an MRI that fits spread cancer. Group 4: PSA rise on 3 checks in a row above the lowest level and above 2ng/ml over 3 months, PSA doubling time under 12 months.
Main reasons for not taking part
- Prostate cancer that has not spread
- More than 3 months of hormone treatment (ADT) at screening
- Groups 1-3: already started abiraterone, apalutamide, darolutamide or enzalutamide
- Groups 1-3: already started docetaxel for hormone-sensitive disease
Read by machine on 9 November 2026.
Where in United Kingdom
- The Clatterbridge Cancer Centre NHS Foundation TrustLiverpool, United KingdomNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Trial code
- NCT07837063
- Record updated
- 23 September 2026
- Original description
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.Read full original descriptionShow less
Monitoring Treatment Response With Urine and Serum Metabolome Markers in Patients Treated With Novel Hormone Therapy and Have Either Hormone Sensitive Metastatic Prostate Cancer or Disease Progression on Treatment.
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.
Inclusion: - 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; Bicalutamide, aLHRH (any type) or LHRH (any type) should be continued throughout the study period; Any medication to treat medical conditions (for example hypertension) at enrolment are allowed and should be continued. These should be recorded on the CRF; If the patient takes any complementary therapies (for example cannabis oil), potential risks and drug interactions should be discussed with the patient. If the patient decides to continue with the medication, they should be recorded on the CRF; Group 1-3:; Metastatic (M1) hormone sensitive prostate cancer (conventional or PSMA PET or MRI imaging); Any pelvic lymph nodes (N0 - N1) and any local disease stage (T1-T4); Group 1:; Visceral (M1b) or lymph node (M1a) metastasis, up to 5 bone metastasis; Treatment decision for darolutamide by clinician Group 2; High volume bone metastasis (>5), other sites are allowed (M1a or 1b); Treatment decision for darolutamide by clinician Group 3; Any metastasis, M1a or 1b); Treatment decision for darolutamide and docetaxel by clinician; Group 4; Metastatic disease progression on PSA, imaging, or both; Currently on abiraterone, apalutamide, darolutamide or enzalutamide; PSA progression is defined as 3 consecutive raises above nadir and > 2ng/ml over a period of 3 months, PSA doubling time <12 months; Imaging can be any of the following: CT scan, NM bone scan, PSMA PET, MRI; Prior chemotherapy for mHSPC or CRPC is acceptable, but not mandatory; Any treatment decision by clinician according to patient fitness, wishes and previous treatment according to standard of care protocols for CRCP is allowed.
Exclusion: - 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.