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

• Conditions: Prostate Cancer Metastatic

• Registration Number: NCT03089099
• Lead Sponsor: Fudan University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-20
• Study First Submitted QC: 2017-03-23
• Study First Posted: 2017-03-24
• Status Verified: 2017-04
• Study Start: 2017-04-24
• Last Update Submitted: 2017-04-27
• Last Update Posted: 2017-05-01
• Primary Completion: 2019-04
• Study Completion: 2019-04

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) 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)
5. Have been received hormonal therapy and progressed into castration-resistant stage
6. Not yet receiving chemotherapy
7. Patients are willing to participate and can be followed up regularly

Exclusion Criteria

1. Received the treatment of abiraterone acetate previously
2. Patients received chemotherapy previously
3. 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

Primary Outcome Measures

Name	Time	Method
overall survival	2 years	Overall survival was defined as the period of time from inclusion to death from any cause, or to the last follow up date.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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