High-risk prostate cancer lymph node metastasis
Conditions
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
Male
Age
50 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >= 50 years; 2. Patients must have histologically or cytologically confirmed prostate adenocarcinoma; 3. PSA >= 20 ng/ml or Gleason score >= 8; 4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) score of 0-2; 5. Expected survival >= 6 months; 6. Normal bone marrow function: absolute neutrophil count = 1.5 × 10^9/L; platelets >= 75 × 10^9/L; hemoglobin >= 90 g/L; white blood cell count = 3.0 × 10^9/L; 7. Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 1.5 times ULN and direct bilirubin = 50%; QTc interval = 3.5 mmol/L; 11. Normal blood pressure: systolic = 50 mL/min; 13. Prospective subjects can understand and are willing to sign the informed consent form; 14. Able to comply with study visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1.There are contraindications for MRI examination, such as metal implants in the body, claustrophobia, etc. 2.Patients with any missing items in baseline clinical and pathological information; 3.Have a clear history of neurological or mental disorders, such as dementia, epilepsy, or seizure proneness; 4.In the researcher's judgment, there are factors that seriously endanger the safety of the subjects, or concomitant diseases that affect the subjects' completion of this study (such as severe diabetes, thyroid disease, and mental illness, etc.), or there are factors that affect the safety of the patients or serious and/or unstable medical, mental, or other conditions (including abnormal laboratory tests) that affect the patient's ability to provide informed consent, or there are any psychological, family, sociological, or geographical conditions that affect the research plan and follow-up plan; 5.The researcher believes that he is not suitable to participate in this clinical trial for any reason; 6.Unable to provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (for diagnosis of prostate cancer); | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessment indicators (incidence of postoperative complications; incidence of serious adverse events);Clinical efficacy (progression-free survival; overall survival; disease recurrence rate; postoperative PSA indicators; imaging examinations);Patient satisfaction; | — |
Countries
China
Contacts
Public ContactSheng Tai
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed