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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03089099
Recruitment Status : Unknown
Verified April 2017 by Bo Dai, Fudan University.
Recruitment status was:  Recruiting
First Posted : March 24, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Bo Dai, Fudan University

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.

Condition or disease Intervention/treatment
Prostate Cancer Metastatic Other: Blood drawing

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer


Intervention Details:
  • Other: Blood drawing
    Blood drawing


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. time to prostate specific antigen (PSA) progression [ Time Frame: 2 years ]
    time from inclusion to prostate specific antigen (PSA) progression

  2. time to radiographic progression [ Time Frame: 2 years ]
    time from inclusion to radiographic progression

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with newly Diagnosed High Volume Metastatic Castration-Resistant Prostate Cancer.
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03089099


Contacts
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Contact: Dai Bo, MD +86-21 64175590 bodai1978@126.com

Locations
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China, Shanghai
Fudan University Shanghai Cancer Center Recruiting
Shanghai, Shanghai, China, 200032
Contact: Dai Bo, MD    +86-21 64175590      
Principal Investigator: Dai Bo, MD         
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Dai Bo, MD Fudan University
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Responsible Party: Bo Dai, Clinical Professor of Department of Urology, Fudan University
ClinicalTrials.gov Identifier: NCT03089099    
Other Study ID Numbers: CTC-mCRPC
First Posted: March 24, 2017    Key Record Dates
Last Update Posted: May 1, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Bo Dai, Fudan University:
Metastatic Castration-Resistant Prostate Cancer
circulating tumor cells
Prognosis
Liquid biopsy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplastic Cells, Circulating
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes