prostate cancer
Conditions
Interventions
Gold Standard:Pathological diagnosis of large specimens after radical prostatectomy.
Index test:Combined MRI-TRUS fusion targeted biopsy and systematic biopsy.
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
Male
Age
35 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 35 and 85 years; 2. The serum total PSA >=10ng/ml, the PSA is between 4 and 10 ng/ml while the ratio of free to total PSA was < 0.16; 3. DRE normal or abnormal DRE with lesion confined to the prostate; 4. The PI-RADS of mpMRI scan is 3 to 5; 5. The participant is able to finish the examination in this clinical trial; 6. Signed the informed consent.
Exclusion criteria
Exclusion criteria: 1. The patients had received prostate biopsy in past history. 2. The patients had received treatment for preostate cancer; 3. The patients have contraindications for mpMRI scan, such as claustrophobia, implantation of heart pacemaker, metallic medical instrumen and GFR =< 50mL/min; 4. The patients have contraindications for prostate biopsy, such as rectofistula and active urinary tract infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| detection rate of clinically significant prostate cancer with Grade Group = 2; | — |
Secondary
| Measure | Time frame |
|---|---|
| detection rate of clinically insignificant prostate cancer with Grade Group 1;detection rate of prostate cancer by Combined Biopsy and Systematic Biopsy; | — |
Countries
China
Contacts
Public ContactYang Bin
Shanghai Tenth People's Hospital
Outcome results
None listed