Tests a personalized, reduced-core prostate biopsy method for prostate cancer
Tests a tailored, fewer-core biopsy approach in men with suspected prostate cancer.
Plain-language title generated from the registry record
Registry title: Personalized Optimization of Systematic Prostate Biopsy
Key facts
- Where
- Fuzhou, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 50 and 95 years old?
Source: NCT05998278, who can take part
Where in China
- Department of Urology, Fujian Union Hospital, Fujian Medical UniversityFuzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fujian Medical University Union Hospital
- Trial code
- NCT05998278
- Record updated
- 18 December 2025
- Original description
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.Read full original descriptionShow less
Diagnostic Performance of a Individualized Reduced-Core Biopsy Strategy in Prostate Cancer: A Prospective, Randomized Controlled Study
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.
Inclusion: 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.
Exclusion: previous biopsy cases; Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy; clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention; Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound; unable to follow the plan.