prostate cancer
Conditions
Interventions
Group A:Transperineal targeted + systematic prostate biopsy assisted by self-developed prostate cancer diagnostic tool
Group B:Traditional transperineal targeting + systematic prostate puncture
Group C:Traditional systematic transperineal prostate biopsy
Sponsors
Fudan University Shanghai Cancer Center
Eligibility
Sex/Gender
Male
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Phase 1: Build a development queue for auxiliary diagnostic tools 1. Age 18-80 years old; 2. Pathological diagnosis of prostate adenocarcinoma by puncture; 3. No contraindications for radical resection of prostate cancer; 4. No anti-tumor treatment for prostate cancer. Phase 2: prospective, open, random based on the deep learning new prostate cancer diagnostic tool-assisted targeted plus system prostate biopsy vs. traditional prostate system puncture cohort 1. Male age 18-80 years old; 2. PSA 4-20ng/ml; 3. Negative digital rectal examination; 4. Subjects are willing to sign the agreement and are willing to comply with the research protocol.
Exclusion criteria
Exclusion criteria: Phase 1: Build a development queue for auxiliary diagnostic tools 1. Unable to accept multi-parameter prostate magnetic resonance examination; 2. Cannot tolerate radical resection of prostate cancer; 3. Do not accept radical resection of prostate cancer. Phase 2: prospective, open, random based on the deep learning new prostate cancer diagnostic tool-assisted targeted plus system prostate biopsy vs. traditional prostate system puncture cohort 1. Previously received prostate biopsy and radical resection of prostate cancer; 2. Previously received multi-parameter prostate magnetic resonance; 3. There are contraindications to MRI; 4. Subjects have severe urinary tract obstruction symptoms and urinary tract infections; 5. The subject's renal function is severely impaired and requires dialysis treatment or the basic creatinine level is greater than 2 times the upper limit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The accuracy of diagnosing early prostate cancer;Probability of finding clinically significant prostate cancer;SEN, SPE, ACC, AUC of ROC; | — |
Secondary
| Measure | Time frame |
|---|---|
| Rate of finding all prostate cancers;Rate of complications after prostate biopsy; | — |
Countries
China
Contacts
Public ContactBo Dai
Fudan University Shanghai Cancer Center
Outcome results
None listed