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

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.

Study Overview

• Status: Unknown
• Conditions: Prostatic Neoplasms; Prostatic Adenoma
• Intervention / Treatment: Other: Blood draws

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 Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Jun Qi, MD.; Phone Number: 021-20578080; Email: jasonqi@sh163.net
• Study Contact Backup: Name: Jie Ding, MD.; Postdoc.; Phone Number: +8613564315425; Email: 769233885@qq.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Recruiting
      • Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
      • Contact: Jun Qi, MD.; Phone Number: +86-021-25078080; Email: qijun@xinhuamed.com.cn
      • Principal Investigator: Jun Qi, MD.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prostate cancer patients; Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.	Other: Blood draws; Blood draws, from peripheral veins, each time 2 tubes, each 5 ml.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique	This step should be completed within the day when the peripheral venous blood is drawn.	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	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.	On the day of operation
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique	This step should be completed within the day when the peripheral venous blood is drawn.	3 months after operation
CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique	This step should be completed within the day when the peripheral venous blood is drawn.	12 months after operation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prostate specific antigen (PSA) level measurement using peripheral venous blood	The blood should be drawn together with that for CTC detection	3 months after operation
Prostate specific antigen (PSA) level measurement using peripheral venous blood	The blood should be drawn together with that for CTC detection	6 months after operation
PSA level measurement using peripheral venous blood	The blood should be drawn together with that for CTC detection	9 months after operation
Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan	Radiological evaluation should be conducted after the blood is drawn for CTC and PSA detection.	12 months after operation

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Collaborators: Shanghai Shen Kang Hospital Development Center

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2016
• Primary Completion (Anticipated): March 30, 2019
• Study Completion (Anticipated): March 30, 2019

Study Registration Dates

• First Submitted: October 18, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimate): October 21, 2016

Study Record Updates

• Last Update Posted (Actual): July 10, 2018
• Last Update Submitted That Met QC Criteria: July 8, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Circulating tumor cell; Prostate specific antigen (PSA); Epithelial to mesenchymal transition; Partin table
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Male; Prostatic Diseases; Neoplastic Processes; Neoplasm Metastasis; Prostatic Neoplasms; Adenoma; Prostatic Hyperplasia; Neoplastic Cells, Circulating
• Other Study ID Numbers: XH-16-028

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes