prostate cancer
Conditions
Interventions
Gold Standard:Prostate needle biopsy
Index test:PSMA PET/MR
Sponsors
Dong Chen
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Patients with suspected prostate cancer: 1. Patients with newly diagnosed prostate lesions with abnormally elevated TPSA; 2. Patient resists or is not suitable for prostate biopsy or has a fear of prostate puncture; 3. The patient has no contraindications for PSMA-PET/MR examination; 4. Subject has non-metastatic or only prostate cancer with suspected regional pelvic lymph node metastases. 5. Written informed consent approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) and a privacy statement required by national regulations must be obtained from the subject or legal representative prior to receiving diagnosis and treatment. 6. Patients must give written informed consent prior to randomization. 7. Subject has an Eastern Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1 at screening
Exclusion criteria
Exclusion criteria: 1. Patients who are unable to undergo surgery due to various factors or have contraindications to surgery. 2. Patients with metastatic prostate cancer. 3. Patients who are allergic to contrast media and cannot undergo PSMAPET/MR examination. 4. Patients who are unwilling to undergo paracentesis-free radical prostatectomy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Positive predicative value;Accuracy;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Negative predictive value; | — |
Countries
P.R.China
Contacts
Public ContactDong Chen; Wei Fan
Sun Yat-sen University Cancer Center
Outcome results
None listed