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

NCT ID: NCT03089099

Last Updated: 2017-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-04-24
• Study Completion Date: 2019-04-30

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.

Conditions

Prostate Cancer Metastatic

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Interventions

Blood drawing

Blood drawing

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Bo Dai

Clinical Professor of Department of Urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dai Bo, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Dai Bo, MD

Role: CONTACT

bodai1978@126.com

+86-21 64175590

Facility Contacts

Dai Bo, MD

Role: primary

+86-21 64175590

Other Identifiers

CTC-mCRPC

Identifier Type: -

Identifier Source: org_study_id