Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer

NCT06482645 | Recruiting

• 1 other identifier: PB-01
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Multicenter randomized controlled trial; Perilesional biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• The PCa detection rate

  One month after the biopsy procedure.

• The high-grade PCa detection rate

  One month after the biopsy procedure.

• The clinically insignificant PCa (ciPCa) detection rate

  One month after the biopsy procedure.

• The Gleason score (GS) of the biopsy sample

  One month after the biopsy procedure.

Other Outcomes (2)

• The self-reported quality of life after the prostate biopsy

  One month after the biopsy procedure.

• The Gleason score (GS) of radical prostatectomy (RP) specimens

  One month after the biopsy procedure.

Study Arms (2)

TB+PB group

EXPERIMENTAL

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

TB+SB group

EXPERIMENTAL

For patients in the TB+SB group, TB cores were obtained from the lesion, followed by 12-core SB.

Procedure: TB+SB

Interventions

TB+PB PROCEDURE

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.

TB+PB group

TB+SB PROCEDURE

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.

TB+SB group

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead
• Beijing Hospital: collaborator
• Shanghai East Hospital: collaborator
• Beijing Friendship Hospital: collaborator
• Chinese People's Liberation Army (PLA) General Hospital: collaborator
• Zhejiang Cancer Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Yi LIU

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi LIU

CONTACT

+86 13611035261; liuyipkuhsc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Locations

CN (1)