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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Isabel Syndikus
- 전화번호: 07900135641
- 이메일: isabel.syndikus@nhs.net
연구 장소
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Merseyside
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Liverpool, Merseyside, 영국, L7 8YA
- The Clatterbridge Cancer Centre NHS Foundation Trust
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연락하다:
- Isabel Syndikus
- 전화번호: 07900135641
- 이메일: isabel.syndikus@nhs.net
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Men with metastatic prostate cancer.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
|---|
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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). |
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Detect clinically significant differences
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Exploratory Metabolic, clinical and survival outcomes.
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- C1600
- IRAS Number: 358728 (기타 식별자: IRAS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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