Evaluation of Transrectal Perilesional Biopsy in Diagnosis of Prostate Cancer

Last updated: April 5, 2025
Sponsor: Peking University First Hospital
Overall Status: Completed

Phase

N/A

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Prostate Cancer

Treatment

Transrectal perilesional/regional systematic biopsy (PB/RSB)

Combination of transrectal systematic biopsy and targeted biopsy

Clinical Study ID

NCT06482658
PB-02
  • Ages 45-85
  • Male

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The age of the patient is between 45 and 85.

  • No previous biopsy,

  • Patients with single suspicious lesion, complete multiparametric magnetic resonanceimaging (mpMRI) data, qualified image quality control, suspicious lesions, andProstate Imaging Reporting and Data System version 2.1 (PI-RADS V2.1) of ≥ 4.

  • Patients were in accordance with the indication of prostate biopsy, includingpatients with suspicious prostate nodes found by digital rectal examination (DRE),the suspicious lesions found by transrectal ultrasound (TRUS) or MRI, totalprostate-specific antigen (tPSA) >10ng/mL, tPSA 4-10ng/mL with free-to-total PSAratio (f/tPSA) <0.16 or PSA density (PSAD) >0.15.

  • The prostate biopsy pathological results were complete. The time interval betweenprostate biopsy and prostate mpMRI examination should not exceed one month.

  • Patients with complete clinical information.

Exclusion

Exclusion Criteria:

  • The mpMRI data was unqualified or incomplete.

  • Patients had received radiotherapy, chemotherapy, androgen deprivation therapy, orsurgery 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.

Study Design

Total Participants: 380
Treatment Group(s): 2
Primary Treatment: Transrectal perilesional/regional systematic biopsy (PB/RSB)
Phase:
Study Start date:
June 12, 2024
Estimated Completion Date:
November 30, 2024

Study Description

Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the combined biopsy approach could effectively detect clinically significant prostate cancer (csPCa), the increased number of biopsy cores would increase the risk of complications and decrease the postoperative quality of life. In recent years, urological and radiologic thinking has changed after realizing that systemic biopsies may be omitted when the chance of missing a clinically significant lesion is low, or when a systemic biopsy has already been done beforehand. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Previous studies found that the majority of csPCa were found within a band of 10-mm radius outside MRI lesions (the penumbra). Based on the penumbra theory, the perilesional/regional systematic biopsy (PB/RSB) has gradually received urologists' attention. Some studies demonstrated that the prostate cancer (PCa) detection rate was not inferior to the combined biopsy with the benefits of using fewer biopsy cores. However, the safety profile warrants further evaluation, especially for transrectal prostate biopsy, and there is still a lack of high-quality, prospective evidence for the transrectal PB/RSB schemes. Thus, this single-center randomized controlled trial (RCT) aims to evaluate the efficacy and safety of transrectal PB/RSB schemes and the routine transrectal TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.

The main questions it aims to answer are:

Does transrectal PB/RSB promote the accurate diagnosis of csPCa? What is the value of PB/RSB in improving the safety of transrectal prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of transrectal PB/RSB and combination of transrectal TB+SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from July 2024 to June 2025. Participants were randomly allocated to PB/RSB group and TB+SB group.

Researchers will compare the cancer detection rates of transrectal PB/RSB and combination of transrectal TB+SB to explore the efficacy of different 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.

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

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