Comparison of TB+PB and TB+6SB for Prostate Cancer Diagnosis

NCT07460843 | Recruiting

• 1 other identifier: TB+6SB_02
• Study Type: interventional
• Target: 592
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial (RCT) is to evaluate the diagnostic efficacy of two novel prostate biopsy schemes, including targeted and perilesional biopsy (TB+PB) and combination of sextant-systematic biopsy and targeted biopsy (TB+6SB). The main questions it aims to answer are: Does TB+PB promote the accurate diagnosis of clinically significant prostate cancer (csPCa)? Could TB+6SB achieve the non-inferior diagnostic efficacy compared to TB+PB scheme? What's the value of TB+6SB in improving the detection of prostate cancer in the negative prostate lobe (contralateral to the index lesion)? In the era of MRI-targeted biopsy (TB), when TB and PB is effectively conducted and allows confident detection of the ROI, do we still need to perform SB? Researchers will compare the cancer detection rates of TB+PB and TB+SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the diagnostic profile of different prostate biopsy schemes through the spatial analysis of the prostate. Participants will: Receive TB+PB or TB+6SB.

Conditions

Prostate Cancer (Diagnosis)

Keywords

Prostate cancer; Prostate biopsy; Targeted biopsy; Perilesional biopsy; Systematic biopsy; Diagnosis; RCT

Outcome Measures

Primary Outcomes (1)

• The clinically significant prostate cancer (csPCa) detection rate for TB+PB and TB+6SB.

  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 (5)

• The PCa detection rate

  One month after the biopsy procedure.

• The clinically insignificant PCa (ciPCa) detection rate

  One month after the biopsy procedure.

• The high-grade PCa detection rate

  One month after the biopsy procedure.

• The Gleason score (GS) of the biopsy sample

  One month after the biopsy procedure.

• The GS of radical prostatectomy (RP) specimens

  One month after the biopsy procedure.

Study Arms (2)

TB+PB group

EXPERIMENTAL

Three-core TB was obtained within the predefined MRI suspicious lesion (ROI), followed by ring-distributed 6-core PB within a 10 to 15 mm radius around the ROI.

Procedure: TB+PB

TB+6SB group

EXPERIMENTAL

Three-core TB within the predefined mpMRI index lesion (ROI) was firstly performed. Then patients received six-core sextant-SB bilaterally with each side two cores in the peripheral zone and one core in the transitional zone.

Procedure: TB+6SB

Interventions

TB+PB 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 or lithotomy 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 patients in the TB+PB group, three-core TB was obtained within the predefined MRI suspicious lesion (ROI), followed by ring-distributed 6-core PB within a 10 to 15 mm radius around the ROI. The location of these nine cores depended on the shape and location of the suspicious lesion. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme.

TB+PB group

TB+6SB 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 or lithotomy 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 patients in the TB+6SB group, three-core TB within the predefined mpMRI index lesion (ROI) was firstly performed. Then patients received six-core sextant-SB bilaterally with each side two cores in the peripheral zone and one core in the transitional zone. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme.

TB+6SB group

Eligibility Criteria

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

You may qualify if:

• The age of the patient is between 18 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 ≥ 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 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 \< 3.
• 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

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms; Disease

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: March 4, 2026
• First Posted: March 10, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CN (1)