Clinical trial NCT02940977: Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique
Official title: Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prostatic Neoplasms
Prostatic Adenoma
Keywords: Circulating tumor cell
Epithelial to mesenchymal transition
Prostate specific antigen (PSA)
Partin table
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Shanghai Shen Kang Hospital Development Center
First posted: 2016-10-21
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
timeFrame: 1 day before operation
measure: 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
timeFrame: On the day of operation
measure: CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
timeFrame: 3 months after operation
measure: CTC total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
timeFrame: 12 months after operation
Secondary outcomes:
measure: Prostate specific antigen (PSA) level measurement using peripheral venous blood
timeFrame: 3 months after operation
measure: Prostate specific antigen (PSA) level measurement using peripheral venous blood
timeFrame: 6 months after operation
measure: PSA level measurement using peripheral venous blood
timeFrame: 9 months after operation
measure: Radiological evaluation including isotope bone scanning and pelvic magnetic resonance imaging (MRI) scan
timeFrame: 12 months after operation
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Xin Hua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
References: