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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older, men only
Conditions the study is for: Cancer, Urology
How many people: 40 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2026to 3 Sep 2030
Phase: Observational

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.

Isabel Syndikus contact

07900135641

isabel.syndikus@nhs.net

United Kingdom1 site

The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, L7 8YA
Isabel Syndikus, 07900135641, isabel.syndikus@nhs.net

Other trials in United Kingdom

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.

Conditions: Cancer, Urology
Medical subject headings: Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07837063
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.

Sep 20263 Sep 2030

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)

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