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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02940977
Other study ID # XH-16-028
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 1, 2016
Est. completion date March 30, 2019

Study information

Verified date July 2018
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact Jun Qi, MD.
Phone 021-20578080
Email jasonqi@sh163.net
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

1. To elucidate the role of CTC detection in the evaluation of risk level in PCa patients, and establish a mathematic model for predicting the pathological status.

2. To explore the possible subtle change in CTC condition after radical prostatectomy.


Description:

1. Detect and evaluate the CTC status (a total of 3 times: 1 day before sugery, 3/12 months after surgery) for all of the PCa patients enrolled. Analyze the CTC result with PSA level, needle biopsy and radiological imaging information.

2. Analyze the difference in CTC amount/Epithelial-Mesenchymal ratio between patients in different D'Amico risk level(low/intermediate/high).

3. Establish a mathematic model based on the CTC results and pathological condition observed in operation (OC, organ confined; EPE, extraprostatic extension; SVI, seminal vesicle invasion; LNI, lymph node invasion), and compare this model with the latest version of Partin table.

4. Detect and compare the CTC and PSA level 3/12 months after surgery. Evaluate the radiological condition in 12 months after blood draw.


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date March 30, 2019
Est. primary completion date March 30, 2019
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Diagnosed with PCa by biopsy, for the first time.

2. Clinical assessed suitable for radical prostatectomy

3. Age = 18 years, able to provide written informed consent

4. No prior systematic or regional treatment for PCa.

5. No neuro-endocrine differentiation or small cell PCa pattern.

6. ECOG status 0-1

7. Expected life span = 12 months.

8. Multiorgan function (heart, lung, liver, kidney) able to tolerate radical prostatectomy, and meet the standard of this study.

Exclusion Criteria:

1. Severe concomitant disease or infection.

2. ALT or AST > 2.5 ULN, or total bilirubin > 1.5 ULN; Creatinine >177umol/L(2.5mg/dL);Plt < 100,000/uL, Neutrophil <1,500/uL.

3. Known or suspected brain metastasis or leptomeningeal carcinomatosis.

4. Another malignancy in the last 5 years, excluding completely cured melanoma.

5. Severe cardiovascular disease, including:

Myocardial infarct within 6 months; Uncontrolled angina pectoris within 3 months; Congestive heart failure; Ventricular arrhythmia history with clinical significance; Morbiz type ? or complete heart block

6. Major surgery (general anesthesia) within 4 weeks.

Study Design


Intervention

Other:
Blood draws
Blood draws, from peripheral veins, each time 2 tubes, each 5 ml.

Locations

Country Name City State
China Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shen Kang Hospital Development Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique This step should be completed within the day when the peripheral venous blood is drawn. 1 day before operation
Primary Pathological findings (whether the patient has: 1.OC, organ confined; 2.EPE, extraprostatic extension; 3. SVI, seminal vesicle invasion; 4. LNI, lymph node invasion) during the radical prostectomy, confirmed by pathology section result The pathology section evaluation will be done by two pathologists independently. A third pathology expert will join to make a final decision if opposite results are given by the two pathologists. On the day of operation
Primary CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique This step should be completed within the day when the peripheral venous blood is drawn. 3 months after operation
Primary CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique This step should be completed within the day when the peripheral venous blood is drawn. 12 months after operation
Secondary Prostate specific antigen (PSA) level measurement using peripheral venous blood The blood should be drawn together with that for CTC detection 3 months after operation
Secondary Prostate specific antigen (PSA) level measurement using peripheral venous blood The blood should be drawn together with that for CTC detection 6 months after operation
Secondary PSA level measurement using peripheral venous blood The blood should be drawn together with that for CTC detection 9 months after operation
Secondary Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan Radiological evaluation should be conducted after the blood is drawn for CTC and PSA detection. 12 months after operation
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