Clinical trial · Interventional
Evaluation of Transrectal Perilesional Biopsy in Diagnosis of Prostate Cancer
Efficacy and Safety Evaluation of Transrectal Perilesional/Regional Systematic Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this single-center randomized controlled trial (RCT) is to evaluate the efficacy and safety of different transrectal prostate biopsy schemes, including transrectal perilesional/regional systematic biopsy (PB/RSB) and combination of transrectal systematic biopsy and targeted biopsy (TB+SB). The main questions it aims to answer are: Does transrectal PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of transrectal prostate biopsy? Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of TB+SB to explore the efficacy of different transrectal prostate biopsy schemes. They will evaluate the safety profile of different transrectal prostate biopsy schemes through the complication rates and postoperative quality of life. Participants will: Receive transrectal PB/RSB or TB+SB.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Combination of transrectal systematic biopsy and targeted biopsy | Procedure | — | UNRESOLVED |
| Transrectal perilesional/regional systematic biopsy (PB/RSB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Transrectal perilesional/regional systematic biopsy (PB/RSB) group
- description
- For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra) through transrectal prostate biopsy. The location of these nine cores depended on the shape and location of the suspicious lesion.
- interventionNames
- Procedure: Transrectal perilesional/regional systematic biopsy (PB/RSB)
- type
- EXPERIMENTAL
- label
- Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group
- description
- For patients in the TB+SB group, three to five transrectal targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core transrectal prostate biopsy.
- interventionNames
- Procedure: Combination of transrectal systematic biopsy and targeted biopsy
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 45 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * The age of the patient is between 45 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 ≥ 4. * 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 \< 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.
References
Publications (1)
- DERIVEDDeng R, Li D, Wu J, Tian S, Shen Q, Hu S, Shang M, Qiu J, Shang J, Zhou J, Cai L, Liu Y, Gong K. Comprehensive Evaluation of Targeted and Perilesional Biopsy in Biopsy-Naive Patients With Prostate Positive Magnetic Resonance Imaging: PERI-PRO Noninferiority Randomized Controlled Trial. J Urol. 2026 Apr;215(4):408-420. doi: 10.1097/JU.0000000000004863. Epub 2025 Nov 21. PMID 41270377