Personalized Optimization of Systematic Prostate Biopsy

Recruiting now · Not applicable

Conditions studied: Prostate Adenocarcinoma

In brief

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.

Key facts

Study ID

NCT05998278

Run by

Fujian Medical University Union Hospital

People needed

330

Starts

2023-08-23

Expected to finish

2025-12-30

Last updated by the study team

2025-12-18

Who can join

Age: 50 and older, up to 95. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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
• (6) 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.

You may not qualify if…

• 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

• Department of Urology, Fujian Union Hospital, Fujian Medical University — Fuzhou, Fujian, China (enrolling)

Full record on ClinicalTrials.gov

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