prostate cancer
Conditions
Interventions
Index test:MRI-US fusion biopsy pathology, PSMA PET/CT-US fusion biopsy pathology, PSMA PET/CT-MRI-US fusion biopsy pathology, systematic biopsy pathology
Sponsors
The First Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
Male
Age
40 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Man who has a suspicion of prostate cancer with any of the following: a. Suspicious nodules in the prostate are found in DRE, any PSA value. b. Suspicious lesions are found in US or MRI, any PSA value. c. PSA>10 ng/ml, any f/tPSA and PSA density value. d. PSA4-10 ng/ml, abnormal f/tPSA value and PSAD value; 2.No previously diagnosed prostate cancer; 3.No previously prostate puncture surgery was performed. 4. Patients who voluntarily participate in this trial after being informed of the existing diagnosis and treatment plan.
Exclusion criteria
Exclusion criteria: 1.Previously diagnosed prostate cancer 2.Previously underwent prostate puncture surgery 3.Contraindication to MRI, including but not restricted to:Pacemaker or other electronic implant; Allergy to MRI contrast, e.g. renal failure (eGFR <30mL/min), tattoos, residual shrapnel or metal items that cannot be removed 4. Simultaneously suffering from other serious systemic diseases that researchers believe may interfere with the treatment, evaluation, and compliance of this trial, including serious respiratory, circulatory, neurological, psychiatric, digestive, endocrine, immune, urinary, and other systemic diseases; Or other patients who are deemed intolerant to general anesthesia surgery based on preoperative evaluation 5. Patients who are currently participating in other clinical trials, or have participated in other clinical trials and have completed them for less than 1 year 6.Researchers believe that patients who are not suitable to participate in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| prostate cancer detection rate;clinnical significant prostate cancer detection rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| consistence;The proportion of avoiding unnecessary biopsies; | — |
Countries
China
Contacts
Public ContactHuang Yuhua
The First Affiliated Hospital of Soochow University
Outcome results
None listed