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

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

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer Metastatic
• Intervention / Treatment: Other: Blood drawing

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Fudan University Shanghai Cancer Center
      • Contact: Dai Bo, MD; Phone Number: +86-21 64175590

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients with newly Diagnosed High Volume Metastatic Castration-Resistant Prostate Cancer.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fudan University
• Investigators: Principal Investigator: Dai Bo, MD, Fudan University

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2017
• Primary Completion (ANTICIPATED): April 1, 2019
• Study Completion (ANTICIPATED): April 1, 2019

Study Registration Dates

• First Submitted: March 20, 2017
• First Submitted That Met QC Criteria: March 23, 2017
• First Posted (ACTUAL): March 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 1, 2017
• Last Update Submitted That Met QC Criteria: April 27, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Prognosis; circulating tumor cells; Liquid biopsy; Metastatic Castration-Resistant Prostate Cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Neoplasm Metastasis; Prostatic Neoplasms; Neoplastic Cells, Circulating
• Other Study ID Numbers: CTC-mCRPC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes