Home › Trials › NCT07460843
Clinical trial Recruiting at 1 site Interventional Ages 18 to 85 Men only

Targeted plus perilesional biopsy versus targeted plus six‑core systematic biopsy to find prostate cancer

Official title: A Head-to-Head Comparison of Targeted and Perilesional Biopsy Versus Combination of Sextant-Systematic Biopsy and Targeted Biopsy for Prostate Cancer Diagnosis: A Randomized Controlled Trial

Run by Peking University First Hospital · NCT07460843 · Data updated 2026-11-12

This study will test whether adding perilesional biopsy to MRI-targeted biopsy or combining targeted biopsy with a six‑core systematic biopsy better finds clinically significant prostate cancer in men with a single MRI-suspicious lesion who have not had a prior biopsy.

Quick facts

Study typeInterventional
Ages18 Years to 85 Years
SexMen only
Enrollment592 (estimated)
SponsorPeking University First Hospital
Academic / other
Drugs / interventionschemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedMarch 1, 2026
Main results expectedDecember 31, 2026
Study endsMarch 31, 2027
Registry record updatedMarch 12, 2026
Trial IDNCT07460843 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Men aged 18–85 who are biopsy‑naïve with a single mpMRI‑suspicious lesion (PI‑RADS ≥3), complete mpMRI data, and clinical indications for biopsy (e.g., elevated PSA or abnormal DRE) are eligible.

Probably not a fit

Patients with prior prostate biopsy, multiple or diffuse MRI lesions, unqualified or missing mpMRI, or other contraindications to prostate biopsy are unlikely to benefit from the specific biopsy schemes tested here.

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 in biopsy‑naïve men with a single mpMRI-suspicious lesion (PI-RADS ≥3) randomly assigns participants to MRI-targeted plus perilesional biopsy (TB+PB) or MRI-targeted plus six‑core systematic biopsy (TB+6SB). Investigators will compare overall and clinically significant cancer detection rates, test non‑inferiority of TB+6SB versus TB+PB, and examine detection in the prostate lobe contralateral to the index lesion. Standardized mpMRI protocols and biopsy procedures are used to limit sampling variability, and outcomes include diagnostic yield, procedural complications, and biopsy burden. The trial is motivated by the penumbra concept that many clinically significant cancers lie close to MRI targets and that routine extended systematic sampling may be avoidable.

Why it matters

Potential benefit: If successful, the approach could preserve or improve detection of clinically significant prostate cancer while reducing the number of biopsy cores, discomfort, and procedure‑related harms.

How similar studies have gone: Previous observational and single‑center studies supporting the penumbra concept suggest perilesional sampling can capture many clinically significant cancers, but direct randomized comparisons of TB+PB versus TB+6SB remain limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* The age of the patient is between 18 and 85.
* 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.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Prostate Cancer (Diagnosis) 34Peking 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.