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.
Přehled studie
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Isabel Syndikus
- Telefonní číslo: 07900135641
- E-mail: isabel.syndikus@nhs.net
Studijní místa
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Merseyside
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Liverpool, Merseyside, Spojené království, L7 8YA
- The Clatterbridge Cancer Centre NHS Foundation Trust
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Kontakt:
- Isabel Syndikus
- Telefonní číslo: 07900135641
- E-mail: isabel.syndikus@nhs.net
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Men with metastatic prostate cancer.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / 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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Detect clinically significant differences
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Exploratory Metabolic, clinical and survival outcomes.
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- C1600
- IRAS Number: 358728 (Jiný identifikátor: IRAS)
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