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.
Przegląd badań
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Isabel Syndikus
- Numer telefonu: 07900135641
- E-mail: isabel.syndikus@nhs.net
Lokalizacje studiów
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Merseyside
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Liverpool, Merseyside, Zjednoczone Królestwo, L7 8YA
- The Clatterbridge Cancer Centre NHS Foundation Trust
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Kontakt:
- Isabel Syndikus
- Numer telefonu: 07900135641
- E-mail: isabel.syndikus@nhs.net
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-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
Men with metastatic prostate cancer.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: COHORT
- Perspektywy czasowe: PROSPECTIVE
Kohorty i interwencje
Grupa / Kohorta |
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Group 1-
Newly diagnosed patients with visceral, with up to five bone metastasis. Treated with hormone therapy and darolutamide. |
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Group 2-
Newly diagnised patients with high volume bone metastasis, treated with hormone therapy and darolutimide . |
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Group 3-
Newly diagnosed patients, any site treated with hormone therapy, darolutimide and doctaxel (triple therapy). |
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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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Detect clinically significant differences
Ramy czasowe: Through study completion, average 1 year.
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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.
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Exploratory Metabolic, clinical and survival outcomes.
Ramy czasowe: Through study completion, average 1 year.
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Characterisation of UMMs on first, second and further line therapies. |
Through study completion, average 1 year.
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Targeted mining of data
Ramy czasowe: Through study completion, average of 1 year
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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
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Metabolite identification
Ramy czasowe: Through study completion, average 1 year
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Progressive or response for identification of potential metabolite and metabolic pathway changes. |
Through study completion, average 1 year
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Correlation of profiles
Ramy czasowe: Through study completion, average 1 year.
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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.
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Detection of early metabolite changes
Ramy czasowe: Through study completion, 1 year average.
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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.
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Biochemical free survival
Ramy czasowe: Through study completion, average 1 year.
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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.
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Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- C1600
- IRAS Number: 358728 (Inny identyfikator: IRAS)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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