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

Study Overview
=================
Brief Summary
-----------------
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. To explore the possible subtle change in CTC condition after radical prostatectomy.

Detailed Description
-----------------
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. Analyze the difference in CTC amount/Epithelial-Mesenchymal ratio between patients in different D'Amico risk level(low/intermediate/high). 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. Detect and compare the CTC and PSA level 3/12 months after surgery. Evaluate the radiological condition in 12 months after blood draw.

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

Conditions
-----------------
Prostatic Neoplasms, Prostatic Adenoma

Intervention / Treatment
-----------------
* Other: Blood draws


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with PCa by biopsy, for the first time. Clinical assessed suitable for radical prostatectomy Age ≥ 18 years, able to provide written informed consent No prior systematic or regional treatment for PCa. No neuro-endocrine differentiation or small cell PCa pattern. ECOG status 0-1 Expected life span ≥ 12 months. Multiorgan function (heart, lung, liver, kidney) able to tolerate radical prostatectomy, and meet the standard of this study. Exclusion Criteria: Severe concomitant disease or infection. 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. Known or suspected brain metastasis or leptomeningeal carcinomatosis. Another malignancy in the last 5 years, excluding completely cured melanoma. 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 Major surgery (general anesthesia) within 4 weeks.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prostate cancer patients<br>Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before. | Other: Blood draws<br>* Blood draws, from peripheral veins, each time 2 tubes, each 5 ml.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| PSA level measurement using peripheral venous blood | The blood should be drawn together with that for CTC detection | 9 months after operation | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Circulating tumor cell, Epithelial to mesenchymal transition, Prostate specific antigen (PSA), Partin table