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

Prostate Cancer Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03089099
• Other study ID #: CTC-mCRPC
• Status: Recruiting
• Phase: N/A
• First received: March 20, 2017
• Last updated: April 27, 2017
• Start date: April 24, 2017
• Est. completion date: April 2019

Study information

• Verified date: April 2017
• Source: Fudan University
• Contact: Dai Bo, MD
• Phone: +86-21 64175590
• Email: bodai1978[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

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).

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Prostate Cancer Metastatic
• Prostatic Neoplasms

Intervention

Other:
• Blood drawing
Blood drawing

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	time to prostate specific antigen (PSA) progression	time from inclusion to prostate specific antigen (PSA) progression	2 years
Secondary	time to radiographic progression	time from inclusion to radiographic progression	2 years
Secondary	complete serologic response rate at 3 month and 6 month	prostate specific antigen response rate at 3 month and 6 month	1 year