Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer

NCT06684652 | Recruiting

• 1 other identifier: TB+6SB_01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including targeted biopsy plus sextant biopsy (3TB+6SB) and combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB). The main questions it aims to answer are: Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of 3TB+6SB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of 3TB+6SB and combination of 3TB+12SB to explore the efficacy of different prostate biopsy schemes. They will evaluate the safety profile of different prostate biopsy schemes through the complication rates and postoperative quality of life. Participants will: Receive 3TB+6SB or 3TB+12SB.

Conditions

Prostate Cancer

Keywords

Prostate cancer; Randomized controlled trial; Targeted biopsy; Systematic biopsy; Sextant biopsy

Outcome Measures

Primary Outcomes (1)

• The clinically significant prostate cancer (csPCa) detection rate

  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 week and one month after the biopsy procedure.

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

  One week and 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)

3TB+6SB group

EXPERIMENTAL

For each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB.

Procedure: 3TB+6SB

3TB+12SB group

EXPERIMENTAL

For patients in the 3TB+12SB group, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB.

Procedure: 3TB+12SB

Interventions

3TB+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 each predefined mpMRI suspicious lesion, urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained sextant six-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.

3TB+6SB group

3TB+12SB 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. Urologists firstly obtained three-core TB from the lesion within the mpMRI suspicious lesion. Then urologists obtained fore-zone 12-core SB. Each core was placed in an individual container and reported separately in accordance with the Ginsburg scheme. Histology was evaluated by senior uropathologists who were blinded to the imaging findings.

3TB+12SB 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 years.
• 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

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: November 10, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion: July 31, 2025
• Study Completion: September 30, 2025
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

CN (1)