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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Observational

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

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 Summary:

  1. Detect and evaluate the CTC status (a total of 5 times: 1 day before sugery, 3/6/9/12 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 in every 3 months (3/6/9/12) after surgery. Evaluate the radiological condition in 12 months after blood draw.

Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Current Primary Outcome:

  • Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique [ Time Frame: 1 day before 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 [ Time Frame: 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.
  • CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique [ Time Frame: 3 months after 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 [ Time Frame: 6 months after 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 [ Time Frame: 9 months after operation ]
    This step should be completed within the day when the peripheral venous blood is drawn.

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • Prostate specific antigen (PSA) level measurement using peripheral venous blood [ Time Frame: 3 months after operation ]
      The blood should be drawn together with that for CTC detection
    • PSA level measurement using peripheral venous blood [ Time Frame: 6 months after operation ]
      The blood should be drawn together with that for CTC detection
    • PSA level measurement using peripheral venous blood [ Time Frame: 9 months after operation ]
      The blood should be drawn together with that for CTC detection
    • PSA level measurement using peripheral venous blood [ Time Frame: 12 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 [ Time Frame: 12 months after operation ]
      Radiological evaluation should be conducted after the blood is drawn for CTC and PSA detection.


    Original Secondary Outcome: Same as current

    Information By: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    Dates:
    Date Received: October 18, 2016
    Date Started: October 2016
    Date Completion: December 2018
    Last Updated: October 19, 2016
    Last Verified: October 2016