CancerMetabolome-PCNCT07837063
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.
An observational study of Cancer and Urology, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2026to 3 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men with metastatic prostate cancer.
Who may be able to join
- - 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.
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- 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, L7 8YA
Isabel Syndikus, 07900135641, isabel.syndikus@nhs.net
About this study
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.
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- | Newly diagnosed patients with visceral, with up to five bone metastasis. Treated with hormone therapy and darolutamide. | |
| Group 2- | Newly diagnised patients with high volume bone metastasis, treated with hormone therapy and darolutimide . | |
| Group 3- | Newly diagnosed patients, any site treated with hormone therapy, darolutimide and doctaxel (triple therapy). | |
| Group 4- | Patients with disease progression and on any novel hormone therapy (PSA and/or imaging). Clinical management will be of a discretion of the clinician. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, average 1 year.
Secondary outcomes (6)
Exploratory Metabolic, clinical and survival outcomes.
Characterisation of UMMs on first, second and further line therapies.
Measured: 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.
Measured: Through study completion, average of 1 year
Metabolite identification
Progressive or response for identification of potential metabolite and metabolic pathway changes.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Through study completion, average 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startSep 2026 (estimated)
- Primary completion3 Sep 2029 (estimated)
- Study completion3 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837063
- Sponsor's protocol ID
- C1600
- Other IDs
- IRAS Number: 358728
- Acronym
- Metabolome-PC
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07837063
- Acronym / sponsor ID
- Metabolome-PC / C1600
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- The Clatterbridge Cancer Centre NHS Foundation TrustUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- 3 Sep 2029 (estimated)
- Study completion
- 3 Sep 2030 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1- | – | –Newly diagnosed patients with visceral, with up to five bone metastasis. Treated with hormone therapy and darolutamide. |
| Group 2- | – | –Newly diagnised patients with high volume bone metastasis, treated with hormone therapy and darolutimide . |
| Group 3- | – | –Newly diagnosed patients, any site treated with hormone therapy, darolutimide and doctaxel (triple therapy). |
| Group 4- | – | –Patients with disease progression and on any novel hormone therapy (PSA and/or imaging). Clinical management will be of a discretion of the clinician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men with metastatic prostate cancer.
Key inclusion criteria (24 listed)
- - 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.
Key exclusion criteria (4 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Detect clinically significant differences
Time frame: Through study completion, average 1 year.
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
6 secondary outcomes
Exploratory Metabolic, clinical and survival outcomes.
Time frame: Through study completion, average 1 year.
Targeted mining of data
Time frame: Through study completion, average of 1 year
Metabolite identification
Time frame: Through study completion, average 1 year
Correlation of profiles
Time frame: Through study completion, average 1 year.
Detection of early metabolite changes
Time frame: Through study completion, 1 year average.
Biochemical free survival
Time frame: Through study completion, average 1 year.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Urology, run by The Clatterbridge Cancer Centre NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Isabel Syndikus (07900135641, isabel.syndikus@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Detect clinically significant differences (time frame: Through study completion, average 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.