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

NCT ID: NCT02723526

Last Updated: 2016-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2019-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Keywords

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Metastatic Hormone-Sensitive Prostate Cancer;circulating tumor cells;Prognosis;Liquid biopsy

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Single arm

Blood drawing

Intervention Type OTHER

Interventions

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Blood drawing

Intervention Type OTHER

Eligibility Criteria

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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);
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Bo Dai

Clinical Professor of Department of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bo Dai, MD

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bo Dai, MD

Role: CONTACT

Phone: +86-21 64175590

Email: [email protected]

Facility Contacts

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Bo Dai, MD

Role: primary

Other Identifiers

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CTC-mHSPC

Identifier Type: -

Identifier Source: org_study_id