Comparing two prostate biopsy methods for finding prostate cancer
Compares two biopsy methods for diagnosing prostate cancer in adults.
Plain-language title generated from the registry record
Registry title: Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis
Key facts
- Where
- Beijing, ChinaSee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT07460843, who can take part
Where in China
- Peking University First HospitalBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Peking University First Hospital
- Trial code
- NCT07460843
- Record updated
- 12 March 2026
- Original description
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).Read full original descriptionShow less
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
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.
Inclusion: 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: Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate mpMRI examination or prostate biopsy; Patients with previous biopsy; 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.