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

Development of a Prognostic Model for Metastatic Hormone-sensitive Prostate Cancer by Sequentially Analyzing the Expression of Tumor Markers in Circulating Tumor Cells

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02723526
Enrollment
100
Registered
2016-03-30
Start date
2016-03-31
Completion date
2019-03-31
Last updated
2016-03-31

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

Conditions

Prostate Cancer

Keywords

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

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.

Interventions

OTHERBlood drawing

Sponsors

Fudan University
Lead SponsorOTHER

Study design

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),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);

Design outcomes

Primary

MeasureTime frame
time to castration-resistant prostate cancer3 years

Secondary

MeasureTime frame
time to radiographic progression3 years
time to prostate specific antigen (PSA) progression3 years
time to prostate specific antigen (PSA) nadir2 years
complete serologic response rate at 6 month and 12 month1 years

Countries

China

Contacts

Primary ContactBo Dai, MD
bodai1978@126.com+86-21 64175590

Outcome results

None listed

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