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

NCT03089099 | Unknown

• 1 other identifier: CTC-mCRPC
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

Metastatic Castration-Resistant Prostate Cancer; circulating tumor cells; Prognosis; Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• time to prostate specific antigen (PSA) progression

  2 years

• time to radiographic progression

  2 years

• complete serologic response rate at 3 month and 6 month

  1 year

Interventions

Blood drawing OTHER

Blood drawing

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male patients
• yrs and older, and 80 yrs and younger
• Histologically or cytologically proven prostate adenocarcinoma;
• 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)
• Have been received hormonal therapy and progressed into castration-resistant stage
• Not yet receiving chemotherapy
• Patients are willing to participate and can be followed up regularly

You may not qualify if:

• Received the treatment of abiraterone acetate previously
• Patients received chemotherapy previously
• 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).

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Dai Bo, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dai Bo, MD

CONTACT

+86-21 64175590; bodai1978@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor of Department of Urology

Study Record Dates

• First Submitted: March 20, 2017
• First Posted: March 24, 2017
• Study Start: April 24, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: May 1, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)