Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique

Prostatic Neoplasms Clinical Trial

Official title:

Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02940977
• Other study ID #: XH-16-028
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Adenoma
• Neoplastic Cells, Circulating
• Prostatic Adenoma
• Prostatic Hyperplasia
• Prostatic Neoplasms

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