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

Evaluating different biopsy methods for diagnosing prostate cancer

Official title: Efficacy and Safety Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial

Run by Peking University First Hospital · NCT06684652 · Data updated 2026-11-12

This study is testing two different ways to take prostate biopsies to see which one finds cancer better and has fewer side effects for men who might have prostate cancer.

Quick facts

Study typeInterventional
Ages45 Years to 85 Years
SexMen only
Enrollment300 (estimated)
SponsorPeking University First Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedDecember 1, 2024
Main results expectedJuly 31, 2025
Study endsSeptember 30, 2025
Registry record updatedJune 13, 2025
Trial IDNCT06684652 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are men aged 45 to 85 with a single suspicious lesion identified through mpMRI and no prior biopsy.

Probably not a fit

Patients with unqualified or incomplete mpMRI data or those who have previously undergone a biopsy 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 randomized controlled trial aims to assess the efficacy and safety of two prostate biopsy schemes: targeted biopsy plus sextant biopsy (3TB+6SB) and targeted biopsy combined with a 12-core systematic biopsy (3TB+12SB). The study will compare the cancer detection rates and complication rates associated with each method, focusing on the accurate diagnosis of clinically significant prostate cancer and the impact on postoperative quality of life. Participants will receive one of the two biopsy methods based on their eligibility criteria, which include age and specific imaging results.

Why it matters

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

How similar studies have gone: While some retrospective studies suggest that the 3TB+6SB approach may be effective, this study is designed to provide high-quality, prospective evidence, making it a novel evaluation.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* The age of the patient is between 45 and 85 years.
* No previous biopsy.
* Patients with single suspicious lesion, complete multiparametric magnetic resonance imaging (mpMRI) 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 mpMRI examination should not exceed one month.
* Patients with complete clinical information.

Exclusion Criteria:

* The mpMRI data was unqualified or incomplete.
* Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
* Patients with previous biopsy.
* Patients with PI-RADS V2.1 of \< 3.
* 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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Prostate Cancer 1464Peking University First Hospital 99
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.