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Expression of Tumor Markers in Circulating Tumor Cells of Metastatic Hormone-sensitive Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02723526
Recruitment Status : Unknown
Verified March 2016 by Bo Dai, Fudan University.
Recruitment status was:  Recruiting
First Posted : March 30, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
Bo Dai, Fudan University

Brief Summary:
As prostate cancer progresses, tumor cells dissociate and enter the bloodstream. Considered a "liquid biopsy," these circulating tumor cells (CTC) can show how a patient's cancer evolves and responds to treatments. The purpose of this study is to determine whether sequentially analyzing the expression of tumor markers in circulating tumor cells in newly diagnosed metastatic hormone-sensitive prostate cancer patients can predict the outcome of these patients.

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Single arm Other: Blood drawing



Primary Outcome Measures :
  1. time to castration-resistant prostate cancer [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. time to radiographic progression [ Time Frame: 3 years ]
  2. time to prostate specific antigen (PSA) progression [ Time Frame: 3 years ]
  3. time to prostate specific antigen (PSA) nadir [ Time Frame: 2 years ]
  4. complete serologic response rate at 6 month and 12 month [ Time Frame: 1 years ]


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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 Metastatic Hormone-Sensitive 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),Computed Tomography(CT)and Magnetic Resonance Imaging (MRI) revealed non-regional lymph node metastasis, bone metastasis, or visceral metastasis;
  5. Not yet receiving hormonal therapy;
  6. Not yet receiving chemotherapy previously;
  7. Not yet receiving radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
  8. Patients are willing to participate and can be followed up regularly;

Exclusion Criteria:

  1. Received radical prostatectomy, radiotherapy, or transurethral resection of the prostate (TURP) previously;
  2. Received androgen deprivation therapy (including surgical castration, medical castration, anti-androgen therapy, and maximum androgen blockade) before inclusion;
  3. Patients received chemotherapy previously;
  4. 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): NCT02723526


Contacts
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Contact: Bo Dai, 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: Bo Dai, MD    +86-21 64175590    bodai1978@163.com   
Sponsors and Collaborators
Fudan University
Investigators
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Principal Investigator: Bo Dai, MD Fudan University

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Responsible Party: Bo Dai, Clinical Professor of Department of Urology, Fudan University
ClinicalTrials.gov Identifier: NCT02723526     History of Changes
Other Study ID Numbers: CTC-mHSPC
First Posted: March 30, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Bo Dai, Fudan University:
Metastatic Hormone-Sensitive Prostate Cancer;circulating tumor cells;Prognosis;Liquid biopsy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Neoplastic Cells, Circulating
Hypersensitivity
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Immune System Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs