NCT05998278Recruiting
Personalized Optimization of Systematic Prostate Biopsy
Diagnostic Performance of a Individualized Reduced-Core Biopsy Strategy in Prostate Cancer: A Prospective, Randomized Controlled Study
Source: ClinicalTrials.gov · Last updated 18 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 330 (estimated)
- First submitted
- 26 Jun 2023
- Start date
- 23 Aug 2023
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Prostate cancer
- NCT number
- NCT05998278
What you commit to
- Study type: Interventional
- Planned participants: 330
- From 23 Aug 2023 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- previous biopsy cases;
- Patients who have undergone prostate-related surgery, radiotherapy, or anti-androgen therapy;
Other illness
- clotting disordersPatients with severe systemic diseases, such as cardiovascular and cerebrovascular disorders, are not appropriate candidates for surgical intervention.
Other
- Patients whopresented with severe hemorrhoids or rectal stenosis, rendering them intolerant to transrectal ultrasound
- unable to follow the plan.
Who the study is looking for
- 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.
Age in the registry: 50 years to 95 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Urology, Fujian Union Hospital, Fujian Medical University Coordinator of this site? Confirm its status | Fuzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.