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

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

Sponsors

Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Collaborator: Shanghai Shen Kang Hospital Development Center

Source 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.

Overall Status Recruiting
Start Date October 1, 2016
Completion Date March 30, 2019
Primary Completion Date March 30, 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique 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 On the day of operation
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique 3 months after operation
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique 12 months after operation
Secondary Outcome
Measure Time Frame
Prostate specific antigen (PSA) level measurement using peripheral venous blood 3 months after operation
Prostate specific antigen (PSA) level measurement using peripheral venous blood 6 months after operation
PSA level measurement using peripheral venous blood 9 months after operation
Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan 12 months after operation
Enrollment 120
Condition
Intervention

Intervention type: Other

Intervention name: Blood draws

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

Arm group label: Prostate cancer patients

Eligibility

Sampling method: Non-Probability Sample

Criteria:

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.

Gender: Male

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Overall Contact

Last name: Jun Qi, MD.

Phone: 021-20578080

Email: [email protected]

Location
facility status contact investigator Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine Jun Qi, MD. +86-021-25078080 [email protected] Jun Qi, MD. Principal Investigator
Location Countries

China

Verification Date

July 2018

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Investigator full name: Jun Qi

Investigator title: Head of the Urology Department

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Prostate cancer patients

Description: Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.

Patient Data Yes
Study Design Info

Observational model: Case-Only

Time perspective: Prospective

Source: ClinicalTrials.gov