Evaluation of Transrectal Perilesional Biopsy in Diagnosis of Prostate Cancer

NCT06482658 | Completed

• 1 other identifier: PB-02
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Randomized controlled trial; Transrectal perilesional biopsy; Transrectal regional systematic biopsy

Outcome Measures

Primary Outcomes (1)

• The clinically significant prostate cancer (csPCa) detection rate for PB/RSB 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 (7)

• The overall complication rate

  One month after the biopsy procedure.

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

  One month after the biopsy procedure.

• The operation time of prostate biopsy

  During the prostate biopsy procedure.

• The PCa detection rate

  One month after the biopsy procedure.

• The clinically insignificant PCa detection rate

  One month after the biopsy procedure.

Study Arms (2)

Transrectal perilesional/regional systematic biopsy (PB/RSB) group

EXPERIMENTAL

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.

Procedure: Transrectal perilesional/regional systematic biopsy (PB/RSB)

Combination of transrectal systematic biopsy and targeted biopsy (TB+SB) group

EXPERIMENTAL

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.

Procedure: Combination of transrectal systematic biopsy and targeted biopsy

Interventions

Transrectal perilesional/regional systematic biopsy (PB/RSB) PROCEDURE

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. 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.

Transrectal perilesional/regional systematic biopsy (PB/RSB) group

Combination of transrectal systematic biopsy and targeted biopsy PROCEDURE

The biopsy procedure was conducted by a highly skilled and experienced urologist who specializes in performing prostate biopsies. Prophylactic antibiotics were routinely used both before and one day prior to scheduled surgery. Each patient was placed in the left lateral position. The ultrasound equipment used included a color Doppler ultrasound diagnostic instrument (Hitachi HiVision, Philips Epiq 7), transrectal probes, and corresponding puncture needle guns. Color Doppler examination was performed from the base to the apex. 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.

Combination of transrectal systematic biopsy and targeted biopsy (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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University First Hospital: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (1)

• Deng 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. 2025 Dec 22:101097JU0000000000004863. doi: 10.1097/JU.0000000000004863. Online ahead of print.

  PMID: 41270377 DERIVED

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, 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: June 12, 2024
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 8, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)