Personalized Optimization of Systematic Prostate Biopsy
Recruiting · NCT05998278 · Interventional (participants receive a specific treatment) · Lead sponsor: Fujian Medical University Union Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Targeted biopsy combined systematic biopsy is the gold standard for diagnosis of prostate cancer. Excessive cores in systematic biopsy increases the risk of puncture trauma， bleeding and infection. On the basis of establishing a model with DRS stratification to reduce the cores of systematic biopsy, we propose the (12 cores -x) model innovatively. We hope that through this prospective study to verify the efficacy of the model and provide patients with a new biopsy model with high accuracy and fewer complications. In this study， patients with suspected prostate cancer were randomly divided into two groups. Experimental group received targeted biopsy combined personalized systematic biopsy, and the control group received systematic biopsy .The differences of the detection rate of Prostate cancer between the two groups were compared.
Who can take part
Inclusion criteria
- Patients with lesions found on rectal examination with any PSA value;
- Patients with abnormal lesions found on imaging with any PSA value;
- PSA \>10.0 ng.ml-1;
- Patients with PSA of 4.0-10.0 ng.ml-1 and fPSA/tPSA \< 0.16; (5 ) mpMRI was performed prior to biopsy and Prostate Imaging Reporting and Data System (PI-RADS V2.1) assessment category ≥3
- Willing to truthfully fill in the subject survey scale; (7) Willing to undergo follow-up; (8) The patient himself or his authorized immediate family member has signed the informed consent for clinical trial.
Exclusion criteria
- previous biopsy cases;
- Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;
- Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound
- clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.
- unable to follow the plan.
Where it is running
1 location listed.
- Department of Urology, Fujian Union Hospital, Fujian Medical University - Fuzhou, Fujian, China