Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer

Study Overview
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Brief Summary
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As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a liquid biopsy, these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.

Official Title
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Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells

Conditions
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Prostate Cancer

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),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis; Not yet receiving hormonal therapy; Not yet receiving chemotherapy previously; Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously; Patients are willing to participate and can be followed up regularly； Exclusion Criteria: Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously; Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion; 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single arm<br> | Other: Blood drawing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to castration-resistant prostate cancer |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to radiographic progression |  | 3 years | 
| time to prostate specific antigen (PSA) progression |  | 3 years | 
| time to prostate specific antigen (PSA) nadir |  | 2 years | 
| complete serologic response rate at 6 month and 12 month |  | 1 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metastatic Hormone-Sensitive Prostate Cancer；circulating tumor cells；Prognosis；Liquid biopsy