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. (Metabolome-PC)

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 Overview

• Status: Not yet recruiting
• Conditions: Cancer; Urology

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Isabel Syndikus; Phone Number: 07900135641; Email: isabel.syndikus@nhs.net

Study Locations

• United Kingdom
  • Merseyside
    • Liverpool, Merseyside, United Kingdom, L7 8YA
      • The Clatterbridge Cancer Centre NHS Foundation Trust
      • Contact: Isabel Syndikus; Phone Number: 07900135641; Email: isabel.syndikus@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with metastatic prostate cancer.

Description

Inclusion Criteria:

• - 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 Criteria:

• - 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

Study Plan

How is the study designed?

Design Details

• Observational Models: COHORT
• Time Perspectives: PROSPECTIVE

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Through study completion, average 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Metabolic, clinical and survival outcomes.	Characterisation of UMMs on first, second and further line therapies.	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.	Through study completion, average of 1 year
Metabolite identification	Progressive or response for identification of potential metabolite and metabolic pathway changes.	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.	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.	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)	Through study completion, average 1 year.

Collaborators and Investigators

• Sponsor: The Clatterbridge Cancer Centre NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 3, 2029
• Study Completion (Estimated): September 3, 2030

Study Registration Dates

• First Submitted: September 7, 2026
• First Submitted That Met QC Criteria: September 17, 2026
• First Posted (Actual): September 23, 2026

Study Record Updates

• Last Update Posted (Actual): September 23, 2026
• Last Update Submitted That Met QC Criteria: September 17, 2026
• Last Verified: August 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: C1600; IRAS Number: 358728 (Other Identifier: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No