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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)

17 settembre 2026 aggiornato da: The Clatterbridge Cancer Centre NHS Foundation Trust

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Tipo di studio

Osservativo

Iscrizione (Stimato)

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Nome: Isabel Syndikus
Numero di telefono: 07900135641
Email: isabel.syndikus@nhs.net

Luoghi di studio

Regno Unito
- Merseyside
  - Liverpool, Merseyside, Regno Unito, L7 8YA
    - The Clatterbridge Cancer Centre NHS Foundation Trust
    - Contatto:
      
      Isabel Syndikus
      
      Numero di telefono: 07900135641
      
      Email: isabel.syndikus@nhs.net

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

Sessi ammissibili allo studio

Maschio

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

Men with metastatic prostate cancer.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Modelli osservazionali: COHORT
Prospettive temporali: PROSPECTIVE

Numero di gruppi/coorti

Coorti e interventi

Gruppo / Coorte
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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Detect clinically significant differences Lasso di tempo: 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	Through study completion, average 1 year.

Misure di risultato secondarie

Misura del risultato	Misura Descrizione	Lasso di tempo
Exploratory Metabolic, clinical and survival outcomes. Lasso di tempo: Through study completion, average 1 year.	Characterisation of UMMs on first, second and further line therapies.	Through study completion, average 1 year.
Targeted mining of data Lasso di tempo: Through study completion, average of 1 year	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 Lasso di tempo: Through study completion, average 1 year	Progressive or response for identification of potential metabolite and metabolic pathway changes.	Through study completion, average 1 year
Correlation of profiles Lasso di tempo: Through study completion, average 1 year.	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 Lasso di tempo: Through study completion, 1 year average.	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 Lasso di tempo: Through study completion, average 1 year.	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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Clatterbridge Cancer Centre NHS Foundation Trust

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

3 settembre 2029

Completamento dello studio (Stimato)

3 settembre 2030

Date di iscrizione allo studio

Primo inviato

7 settembre 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 settembre 2026

Primo Inserito (Effettivo)

23 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)