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

• Conditions: Prostatic Adenoma; Prostatic Neoplasms
• Interventions: Other: Blood draws

• Registration Number: NCT02940977
• Lead Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2016-10-01
• Study First Submitted: 2016-10-18
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-08
• Last Update Posted: 2018-07-10
• Primary Completion: 2019-03-30
• Study Completion: 2019-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prostate cancer patients	Blood draws	Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.

Primary Outcome Measures

Name	Time	Method
Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique	1 day before operation	This step should be completed within the day when the peripheral venous blood is drawn.
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique	12 months after operation	This step should be completed within the day when the peripheral venous blood is drawn.
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	On the day of operation	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.

Secondary Outcome Measures

Name	Time	Method
Prostate specific antigen (PSA) level measurement using peripheral venous blood	6 months after operation	The blood should be drawn together with that for CTC detection
PSA level measurement using peripheral venous blood	9 months after operation	The blood should be drawn together with that for CTC detection
Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan	12 months after operation	Radiological evaluation should be conducted after the blood is drawn for CTC and PSA detection.

Trial Locations

Locations (1)

Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China