Personalized biopsy approach for prostate cancer diagnosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates a new personalized biopsy model for diagnosing prostate cancer, aiming to reduce the number of biopsy cores needed while maintaining diagnostic accuracy. Patients with suspected prostate cancer are randomly assigned to either an experimental group receiving a targeted biopsy combined with a personalized systematic biopsy or a control group receiving standard targeted biopsy combined with systematic biopsy. The study evaluates the efficacy of this new approach by comparing the cancer detection rates between the two groups. The goal is to minimize complications associated with excessive biopsy cores while ensuring accurate diagnosis.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Urology, Fujian Union Hospital, Fujian Medical University
  Fuzhou, Fujian, China Recruiting

Study contacts

• Principal investigator: Zhenlin Chen — Department of Urology, Fujian Union Hospital, Fujian Medical University
• Study coordinator: Jiabing Zheng
• Email: xhyykjk@163.com
• Phone: +8613799422519

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Focal HDR-Brachytherapy for Prostate Cancer

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• PSMA PET/CT plus MRI to find higher‑grade prostate cancer in men on active surveillance

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.