NCT06482645 Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer
| NCT ID | NCT06482645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Peking University First Hospital |
| Condition | Prostate Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 640 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 640 participants in total. It began in 2024-07-01 with a primary completion date of 2026-09-30.
⚠ 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 multicenter randomized controlled trial (RCT) is to evaluate the efficacy of different prostate biopsy schemes, including perilesional biopsy (PB) and combination of systematic biopsy and targeted biopsy (TB+SB). The main questions it aims to answer are: Does PB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB and TB+SB to explore the efficacy of different prostate biopsy schemes. Participants will: Receive TB+PB or TB+SB.
Eligibility Criteria
Inclusion Criteria: * The age of the patient is between 45 and 85. * No previous biopsy. * Patients with single suspicious lesion, complete MRI 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 MRI examination should not exceed one month. * Patients with complete clinical information. Exclusion Criteria: * The MRI data was unqualified or incomplete. * Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, or surgery treatment before prostate MRI examination or prostate biopsy. * Patients with previous biopsy. * Patients with PI-RADS V2.1 of \< 4. * 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 NCT06482645 clinical trial?
This trial is open to male participants only, aged 45 Years or older, up to 85 Years, studying Prostate Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06482645 currently recruiting?
Yes, NCT06482645 is actively recruiting participants. Contact the research team at liuyipkuhsc@163.com for enrollment information.
Where is the NCT06482645 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06482645 clinical trial?
NCT06482645 is sponsored by Peking University First Hospital. The principal investigator is Yi LIU at Peking University First Hospital. The trial plans to enroll 640 participants.
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