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Clinical Trials in China / NCT05998278
Recruiting Not applicable

Personalized Optimization of Systematic Prostate Biopsy

NCT05998278 · tracked via the Priya Life Science China tracker
Sponsor
Fujian Medical University Union Hospital
Phase
Not applicable
Started
2023-08-23
Last updated
2025-12-18

Condition(s) studied

Prostate Adenocarcinoma

Investigational drug(s) / intervention(s)

Personalized Optimization of Systematic Prostate Biopsy

Personalized Optimization of Systematic Prostate Biopsy: Login the model based on our previous study (https://daringsky.shinyapps.io/prediction\_v2/) allows for input of age, BMI, serum PSA, size and location of suspicious lesions, PIRADS - V2 score, and prostate volume to generate an individualized needle distribution map,then targeted biopsy combined personalized optimization of systematic prostate biopsy was performed.

Study summary

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.

Eligibility

Sex
MALE
Min age
50 Years
Max age
95 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with lesions found on rectal examination with any PSA value; 2. Patients with abnormal lesions found on imaging with any PSA value; 3. PSA \>10.0 ng.ml-1; 4. 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. Exclusion Criteria: 1. previous biopsy cases; 2. Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy; 3. Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound 4. clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention. 5. unable to follow the plan.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Department of Urology, Fujian Union Hospital, Fujian Medical University Fuzhou Fujian Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05998278 on ClinicalTrials.gov ↗ ← All trials in China