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

• Conditions: Prostate Cancer
• Interventions: Other: Blood drawing

• Registration Number: NCT02723526
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study Start: 2016-03
• Study First Submitted: 2016-03-26
• Study First Submitted QC: 2016-03-26
• Study First Posted: 2016-03-30
• Last Update Submitted: 2016-03-30
• Last Update Posted: 2016-03-31
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

Inclusion Criteria

1. Male patients;
2. 18 yrs and older, and 80 yrs and younger;
3. Histologically or cytologically proven prostate adenocarcinoma;
4. 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;
5. Not yet receiving hormonal therapy;
6. Not yet receiving chemotherapy previously;
7. Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
8. Patients are willing to participate and can be followed up regularly；

Exclusion Criteria

1. Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
2. Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
3. Patients received chemotherapy previously;
4. 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);

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Single arm	Blood drawing	-

Primary Outcome Measures

Name	Time	Method
time to castration-resistant prostate cancer	3 years

Secondary Outcome Measures

Name	Time	Method
time to prostate specific antigen (PSA) nadir	2 years
complete serologic response rate at 6 month and 12 month	1 years
time to prostate specific antigen (PSA) progression	3 years
time to radiographic progression	3 years

Trial Locations

Locations (1)

Fudan University Shanghai Cancer Center; 🇨🇳 Shanghai, Shanghai, China