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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2019

Interventions

  • Other: Blood drawing
    • Blood drawing

Clinical Trial Outcome Measures

Primary Measures

  • overall survival
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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).

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fudan University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Bo Dai, Clinical Professor of Department of Urology – Fudan University
  • Overall Official(s)
    • Dai Bo, MD, Principal Investigator, Fudan University
  • Overall Contact(s)
    • Dai Bo, MD, +86-21 64175590, bodai1978@126.com

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