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Clinical trial Recruiting at 1 site Interventional Ages 45 to 85 Men only

Evaluating a new biopsy method for diagnosing prostate cancer

Official title: Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial

Run by Peking University First Hospital · NCT06482645 · Data updated 2026-11-12

This study is testing a new way to take prostate biopsies to see if it can find cancer more accurately and safely than the current methods.

Quick facts

Study typeInterventional
Ages45 Years to 85 Years
SexMen only
Enrollment640 (estimated)
SponsorPeking University First Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJuly 1, 2024
Main results expectedJune 30, 2027
Study endsJuly 31, 2027
Registry record updatedNovember 3, 2026
Trial IDNCT06482645 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are men aged 45 to 85 with a single suspicious lesion and specific imaging results indicating the need for a prostate biopsy.

Probably not a fit

Patients who have had a previous biopsy or whose mpMRI data is unqualified or incomplete may not benefit from this study.

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

What this trial studies

This multicenter randomized controlled trial aims to assess the efficacy and safety of perilesional/regional systematic biopsy (PB/RSB) compared to the combination of systematic biopsy and targeted biopsy (TB+SB) for diagnosing clinically significant prostate cancer. The study will analyze cancer detection rates and complication rates associated with each biopsy method, as well as the impact on postoperative quality of life. Participants will receive either PB/RSB or TB+SB based on their eligibility criteria, which include age and specific imaging results. The trial seeks to provide high-quality evidence regarding the optimization of prostate biopsy techniques.

Why it matters

Potential benefit: If successful, this study could lead to a safer and more accurate method for diagnosing prostate cancer, potentially reducing complications and improving patient quality of life.

How similar studies have gone: Previous studies have shown promising results for similar biopsy approaches, but this trial aims to provide high-quality, prospective evidence for the PB/RSB method.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* The age of the patient is between 45 and 85.
* No previous biopsy.
* Patients with single suspicious lesion, complete MRI data, qualified image quality control, suspicious lesions, and Prostate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of \> 3.
* Patients were in accordance with the indication of prostate biopsy, including patients with suspicious prostate nodes found by digital rectal examination (DRE), the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, total prostate-specific antigen (tPSA) \>10ng/mL, tPSA 4-10ng/mL with free-to-total PSA ratio (f/tPSA) \<0.16 or PSA density (PSAD) \>0.15.
* The prostate biopsy pathological results were complete. The time interval between prostate biopsy and prostate MRI examination should not exceed one month.
* PSA\<50ng/mL.
* Patients with complete clinical information.

Exclusion Criteria:

* The MRI data was unqualified or incomplete.
* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy.
* Patients with previous biopsy.
* Patients with PI-RADS V2.1 of \< 4.
* Patients were not in accordance with the indication of prostate biopsy.
* The patient could not cooperate to complete the prostate biopsy.
* The patients or their family members refused to participate in this study.
* Patients with incomplete clinical information.

Where it's running

  • Peking University First Hospital
    Beijing, Beijing Municipality, China     Recruiting

Study contacts

Similar studies

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

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.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.