Clinical trial · Observational
Establishment and Clinical Assessment of a Prostate Cancer (PCa) Risk Model Based on the Updated Circulating Tumor Cell (CTC) Detection Technique
NCT02940977CI-TRIAL-00033693unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Adenoma | — | UNRESOLVED | — |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draws | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prostate cancer patients
- description
- Patients diagnosed with prostate cancer, confirmed with needle biopsy, and suitable for radical prostatectomy, and have not received any treatments before.
- interventionNames
- Other: Blood draws
Primary outcomes (4)
- measure
- Circulating tumor cell (CTC) total number and epithelial-intermediate-mesenchymal ratio detected by CTC enrichment and FISH technique
- timeFrame
- 1 day before operation
- description
- This step should be completed within the day when the peripheral venous blood is drawn.
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.