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

NCT ID: NCT02940977

Last Updated: 2018-07-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 120 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-10-01
• Study Completion Date: 2019-03-30

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.

Conditions

Prostatic Neoplasms; Prostatic Adenoma

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Prostate cancer patients

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

Blood draws

Intervention Type: OTHER

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

Interventions

Blood draws

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

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Shen Kang Hospital Development Center

OTHER

Sponsor Role: collaborator

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Jun Qi

Head of the Urology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Qi, MD.

Role: CONTACT

jasonqi@sh163.net

021-20578080

Jie Ding, MD.; Postdoc.

Role: CONTACT

769233885@qq.com

+8613564315425

Facility Contacts

Jun Qi, MD.

Role: primary

qijun@xinhuamed.com.cn

+86-021-25078080

Other Identifiers

XH-16-028

Identifier Type: -

Identifier Source: org_study_id