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

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02723526
• Other study ID #: CTC-mHSPC
• Status: Recruiting
• Phase: N/A
• First received: March 26, 2016
• Last updated: March 26, 2016
• Start date: March 2016
• Est. completion date: March 2019

Study information

• Verified date: March 2016
• Source: Fudan University
• Contact: Bo Dai, MD
• Phone: +86-21 64175590
• Email: bodai1978[@]126.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male patients;

2. 18 yrs and older, and 80 yrs and younger;

3. Histologically or cytologically proven prostate adenocarcinoma;

4. Imaging (PET, ECT, etc.) examination 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 TURP previously;

8. Patients are willing to participate and can be followed up regularly;

Exclusion Criteria:

1. Received radical prostatectomy, radiotherapy, or 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);

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Neoplastic Cells, Circulating
• Prostate Cancer
• Prostatic Neoplasms

Intervention

Other:
• Blood drawing

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to castration-resistant prostate cancer		3 years	No
Secondary	time to radiographic progression		3 years	No
Secondary	time to PSA progression		3 years	No
Secondary	time to PSA nadir		2 years	No
Secondary	complete serologic response rate at 6 month and 12 month		1 years	No