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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03089099
Enrollment
100
Registered
2017-03-24
Start date
2017-04-24
Completion date
2019-04-30
Last updated
2017-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer Metastatic

Keywords

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

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.

Interventions

OTHERBlood drawing

Blood drawing

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
overall survival2 yearsOverall survival was defined as the period of time from inclusion to death from any cause, or to the last follow up date.

Secondary

MeasureTime frameDescription
time to prostate specific antigen (PSA) progression2 yearstime from inclusion to prostate specific antigen (PSA) progression
time to radiographic progression2 yearstime from inclusion to radiographic progression
complete serologic response rate at 3 month and 6 month1 yearprostate specific antigen response rate at 3 month and 6 month

Countries

China

Contacts

Primary ContactDai Bo, MD
bodai1978@126.com+86-21 64175590

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026