NCT07460843Recruiting

Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis

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

Source: ClinicalTrials.gov · Last updated 12 Mar 2026

Brief summary (registry, in English)

The goal of this randomized controlled trial (RCT) is to evaluate the diagnostic efficacy of two novel prostate biopsy schemes, including targeted and perilesional biopsy (TB+PB) and combination of sextant-systematic biopsy and targeted biopsy (TB+6SB). The main questions it aims to answer are: Does TB+PB promote the accurate diagnosis of clinically significant prostate cancer (csPCa)? Could TB+6SB achieve the non-inferior diagnostic efficacy compared to TB+PB scheme? What's the value of TB+6SB in improving the detection of prostate cancer in the negative prostate lobe (contralateral to the index lesion)? In the era of MRI-targeted biopsy (TB), when TB and PB is effectively conducted and allows confident detection of the ROI, do we still need to perform SB? Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the diagnostic profile of different prostate biopsy schemes through the spatial analysis of the prostate. Participants will: Receive TB+PB or TB+6SB.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 592 (estimated)
First submitted: 4 Mar 2026
Start date: 1 Mar 2026
Primary completion date: 31 Dec 2026
Lead sponsor: Peking University First Hospital
Diseases: Prostate cancer
NCT number: NCT07460843

What you commit to

Study type: Interventional
Planned participants: 592
From 1 Mar 2026 to the primary completion date, 31 Dec 2026
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

Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy.
Patients with previous biopsy.

Other

The mpMRI data was unqualified or incomplete.
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.

Who the study is looking for

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.

Age in the registry: 18 years to 85 years · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Peking University First Hospital Coordinator of this site? Confirm its status	Beijing	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.