NCT07460843 Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis
| NCT ID | NCT07460843 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Prostate Cancer (Diagnosis) |
| Study Type | INTERVENTIONAL |
| Enrollment | 592 participants |
| Start Date | 2026-03-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 592 participants in total. It began in 2026-03-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Yi Liu
PRINCIPAL INVESTIGATOR
Peking University First Hospital
Frequently Asked Questions
Who can join the NCT07460843 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 85 Years, studying Prostate Cancer (Diagnosis). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07460843 currently recruiting?
Yes, NCT07460843 is actively recruiting participants. Contact the research team at liuyipkuhsc@163.com for enrollment information.
Where is the NCT07460843 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07460843 clinical trial?
NCT07460843 is sponsored by Peking University First Hospital. The principal investigator is Yi Liu at Peking University First Hospital. The trial plans to enroll 592 participants.
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