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

Last updated: July 8, 2018
Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Prostate Disorders

Prostate Cancer

Benign Prostatic Hyperplasia (Enlarged Prostate)

Treatment

N/A

Clinical Study ID

NCT02940977
XH-16-028
  • Ages > 18
  • Male

Study 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.

Eligibility Criteria

Inclusion

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 radicalprostatectomy, and meet the standard of this study.

Exclusion

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

Total Participants: 120
Study Start date:
October 01, 2016
Estimated Completion Date:
March 30, 2019

Study 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.

Connect with a study center

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

    Shanghai, Shanghai 200092
    China

    Active - Recruiting

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