Expression of Molecular Markers in Circulating Tumor Cells of Metastatic Castration-Resistant Prostate Cancer

Study Overview
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Brief Summary
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As prostate cancer progresses into castration-resistant stage from initial hormone-sensitive status, the biological behavior of tumor cells that dissociated from primary lesions changed. Considered a liquid biopsy, these circulating tumor cells (CTCs) can show how a patient's cancer responded to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of molecular markers in high volume circulating tumor cells in metastatic castration-resistant prostate cancer patients can predict the therapeutic effects and outcomes of these patients.

Official Title
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Development of a Prognostic Model for High Volume Metastatic Castration-Resistant Prostate Cancer Patients by Sequentially Analyzing the Expression of Molecular Markers in Circulating Tumor Cells

Conditions
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Prostate Cancer Metastatic

Intervention / Treatment
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* Other: Blood drawing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male patients 18 yrs and older, and 80 yrs and younger Histologically or cytologically proven prostate adenocarcinoma; Imaging examinations including Emission Computed Tomography (ECT), Positron Emission Tomography (PET) and so on revealed a high-volume disease of patients(A high-volume of disease was defined by the presence of visceral metastases or four or more bone lesions with at least one beyond the vertebral bodies and pelvis) Have been received hormonal therapy and progressed into castration-resistant stage Not yet receiving chemotherapy Patients are willing to participate and can be followed up regularly Exclusion Criteria: Received the treatment of abiraterone acetate previously Patients received chemotherapy previously Combined with other malignant tumor history (in addition to the skin basal cell carcinoma or other tumors that have been cured more than five years).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood drawing|Blood drawing|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival | Overall survival was defined as the period of time from inclusion to death from any cause, or to the last follow up date. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to prostate specific antigen (PSA) progression | time from inclusion to prostate specific antigen (PSA) progression | 2 years | 
| time to radiographic progression | time from inclusion to radiographic progression | 2 years | 
| complete serologic response rate at 3 month and 6 month | prostate specific antigen response rate at 3 month and 6 month | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prognosis, Metastatic Castration-Resistant Prostate Cancer, circulating tumor cells, Liquid biopsy