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

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine120 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

120

Conditions

Prostatic Neoplasms Prostatic Adenoma

Interventions

Blood drawsOTHER

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

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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 Ⅱ or complete heart block 6. Major surgery (general anesthesia) within 4 weeks.

Locations (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 1 day before operation

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.

Time frame: On the day of operation

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.

Time frame: 3 months after operation

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.

Time frame: 12 months after operation

Secondary Outcomes

Prostate specific antigen (PSA) level measurement using peripheral venous blood

The blood should be drawn together with that for CTC detection

Time frame: 3 months after operation

Prostate specific antigen (PSA) level measurement using peripheral venous blood

The blood should be drawn together with that for CTC detection

Central Contacts

Jun Qi, MD.

CONTACT

021-20578080 jasonqi@sh163.net

Jie Ding, MD.; Postdoc.

CONTACT

+8613564315425 769233885@qq.com

Data from ClinicalTrials.gov

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