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

NCT02940977 | Unknown

• 1 other identifier: XH-16-028
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 2.To explore the possible subtle change in CTC condition after radical prostatectomy.

Conditions

Prostatic Neoplasms; Prostatic Adenoma

Keywords

Circulating tumor cell; Epithelial to mesenchymal transition; Prostate specific antigen (PSA); Partin table

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (1)

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

Interventions

Blood draws OTHER

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

Prostate cancer patients

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Diagnosed with PCa by biopsy, for the first time.
• Clinical assessed suitable for radical prostatectomy
• Age ≥ 18 years, able to provide written informed consent
• No prior systematic or regional treatment for PCa.
• No neuro-endocrine differentiation or small cell PCa pattern.
• ECOG status 0-1
• Expected life span ≥ 12 months.
• Multiorgan function (heart, lung, liver, kidney) able to tolerate radical prostatectomy, and meet the standard of this study.

You may not qualify if:

• Severe concomitant disease or infection.
• 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.
• Known or suspected brain metastasis or leptomeningeal carcinomatosis.
• Another malignancy in the last 5 years, excluding completely cured melanoma.
• 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
• Major surgery (general anesthesia) within 4 weeks.

Sponsors & Collaborators

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

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Fresh blood 5 ml \*2

MeSH Terms

Conditions

Prostatic Neoplasms; Prostatic Hyperplasia; Neoplastic Cells, Circulating

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jun Qi, MD.

CONTACT

021-20578080; jasonqi@sh163.net

Jie Ding, MD.; Postdoc.

CONTACT

+8613564315425; 769233885@qq.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Urology Department

Study Record Dates

• First Submitted: October 18, 2016
• First Posted: October 21, 2016
• Study Start: October 1, 2016
• Primary Completion: March 30, 2019
• Study Completion: March 30, 2019
• Last Updated: July 10, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)