Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer

Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer: a Multicenter Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Procedure: TB+PB; Procedure: TB+SB

Detailed Description

Currently, combination of systematic biopsy and targeted biopsy (TB+SB) has been recommended for the diagnosis of patients with suspicious lesion found on magnetic resonance imaging (MRI). 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, and there is still a lack of high-quality, prospective evidence for the PB schemes. Thus, this multicenter randomized controlled trial (RCT) aims to evaluate the efficacy of TB+PB schemes and the routine TB+SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.

The main questions it aims to answer are:

Does PB promote the accurate diagnosis of csPCa? What is the value of PB in improving the safety of prostate biopsy? This prospective, multi-institution RCT compared the csPCa detection rates of TB+PB and TB+SB. Participants were prospectively enrolled and were randomly allocated to TB+PB group and TB+SB group.

Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes.

Participants will:

Receive TB+PB or TB+SB.

• Study Type: Interventional
• Enrollment (Estimated): 640
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yi LIU; Phone Number: +86 13611035261; Email: liuyipkuhsc@163.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100034
      • Recruiting
      • Peking University First Hospital
      • Contact: Baowei Zhang; Phone Number: +86 83572466; Email: bdyyll@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TB+PB group; For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.	Procedure: TB+PB; The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. For each predefined MRI suspicious lesion, TB cores were obtained within each predefined MRI suspicious lesion (region of interest, ROI), followed by ring-distributed PB cores within a 10-15 mm radius around the ROI. The location of these cores depended on the shape and location of the suspicious lesion.
Experimental: TB+SB group; For patients in the TB+SB group, TB cores were obtained from the lesion, followed by 12-core SB.	Procedure: TB+SB; The biopsy procedure was conducted by highly skilled and experienced urologists who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. TB cores were obtained from the lesion, followed by 12-core SB.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The clinically significant prostate cancer (csPCa) detection rate for TB+PB and TB+SB	csPCa was defined as PCa with a grade group > 2 or GS ≥ 7. The reference standard was the pathological result.	One month after the biopsy procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Gleason score (GS) of the biopsy sample	The Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.	One month after the biopsy procedure.
The clinically insignificant PCa (ciPCa) detection rate	The ciPCa was defined as PCa with a grade group <2 or GS <3+4. The reference standard was the pathological result.	One month after the biopsy procedure.
The PCa detection rate	The PCa detection rate for TB+PB and TB+SB.	One month after the biopsy procedure.
The high-grade PCa detection rate	The high-grade PCa was defined as PCa with a grade group ≥3 or GS≥4+3. The reference standard was the pathological result.	One month after the biopsy procedure.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The self-reported quality of life after the prostate biopsy	The self-reported levels of pain and discomfort after the prostate biopsy was measured through visual analogue scale (VAS). The minimum and maximum values of VAS are 0 and 10. The higher VAS means the higher level of pain and discomfort.	One month after the biopsy procedure.
The Gleason score (GS) of radical prostatectomy (RP) specimens	For the RP specimens, the Gleason score (GS) was reported by senior uropathologists according to the Standards of Reporting for MRI Targeted Biopsy Studies (START) criteria and interpreted according to the recommendations of the International Society of Urological Pathology (ISUP) Grade Group. The minimum and maximum of GS are 3 and 5. The higher GS means the higher pathological grade.	One month after the biopsy procedure.

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: Zhejiang Cancer Hospital; Beijing Friendship Hospital; Tianjin Medical University Cancer Institute and Hospital; Beijing Hospital; Shanghai East Hospital; First Affiliated Hospital of Chongqing Medical University; Chinese People's Liberation Army (PLA) General Hospital
• Investigators: Principal Investigator: Yi LIU, Peking University First Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: June 25, 2024
• First Submitted That Met QC Criteria: June 25, 2024
• First Posted (Actual): July 1, 2024

Study Record Updates

• Last Update Posted (Actual): June 11, 2026
• Last Update Submitted That Met QC Criteria: June 9, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Prostate cancer; Multicenter randomized controlled trial; Perilesional biopsy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PB-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No