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.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Detect clinically significant differences
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •- 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.
- •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)
- •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
- •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.
排除标准
- •- 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
研究组 & 干预措施
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.
Group 1-
Newly diagnosed patients with visceral, with up to five bone metastasis. Treated with hormone therapy and darolutamide.
结局指标
主要结局
Detect clinically significant differences
时间窗: 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
次要结局
- Exploratory Metabolic, clinical and survival outcomes.(Through study completion, average 1 year.)
- Targeted mining of data(Through study completion, average of 1 year)
- Metabolite identification(Through study completion, average 1 year)
- Correlation of profiles(Through study completion, average 1 year.)
- Detection of early metabolite changes(Through study completion, 1 year average.)
- Biochemical free survival(Through study completion, average 1 year.)