Prostatic Cancer
Conditions
Interventions
Gold Standard:The results of MPUS-TB and TRUS-SB are obtained from the same patient. The gold standard is the pathological diagnosis as csPCa and cisPCa.
Index test:multi-parameter ultrasound targeted biopsy
transrectal ultrasound systematic biopsy
Sponsors
Sichuan Cancer Hospital
Eligibility
Sex/Gender
Male
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Patients over the age of 18 years with a first occurrence of elevated serum PSA concentration or abnormal digital rectal examination for suspected prostate cancer, or who have had a previous prostate biopsy and need to stratified cancer risk before entering the active surveillance phase 2) Prostate mpUS examination was performed before prostate biopsy, and the time interval between mpUS and biopsy was less than 3 months.
Exclusion criteria
Exclusion criteria: 1) Serum PSA concentration over 20 ng/mL. 2) There are contraindications: irreversible coagulation dysfunction; Have been treated for prostate cancer (including radiotherapy, high intensity focused ultrasound, cryotherapy, hyperthermia, etc.); Or urethral prostate surgery within 6 months prior to enrollment 3) There is contraindication of transrectal mpUS (including hypersensitivity to contrast media). 4) Patients with imaging signs of lymph node or metastatic prostate cancer. 5) Any history of hormonal regulation or androgen deprivation in the 6 months prior to screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the proportion of patients with csPCa (using definition A, defined as Gleason = 7) detected by MPUS-TB and TRUS-SB.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Compare the proportion of patients with csPCa detected by MPUS-TB and TRUS-SB (using definition B, i.e., any Gleason grade =7 or Gleason 6 with at least one sample having MCCL=6mm);Compare the proportion of patients with cisPCa detected by MPUS-TB and TRUS-SB (defined as Gleason grade =6, positive samples =2, and positive samples with MCCL 50 mL - Among patients undergoing TB, mpUS, mpMRI, or US/MRI fusion guidance were used, respectively;The proportion of patients with a negative MPUS result converted to a positive MPUS result and/or Gleason grade =7 within two years;To compare the incidence of adverse events after biopsy between MPUS-TB and TRUS-SB;health-related quality of life scores; | — |
Countries
China
Contacts
Public ContactJinshun Xu
Sichuan Cancer Hospital
Outcome results
None listed