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

Official title

Efficacy and Safety Evaluation of Targeted Biopsy Plus Sextant Biopsy in Diagnosis of Prostate Cancer: a Randomized Controlled Trial

Overview

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.

Detailed description

Currently, combination of targeted biopsy and 12-core systematic biopsy (3TB+12SB) has been recommended for the diagnosis of patients with suspicious lesion found on multiparametric magnetic resonance imaging (mpMRI). Although the 3TB+12SB 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 reduced when the chance of missing a clinically significant lesion is low. More and more radiologists and urologists focused on the issue of optimization of prostate biopsy schemes. Some retrospective studies have proved that the cancer detection rate of targeted biopsy plus sextant biopsy (3TB+6SB) was not inferior to 3TB+12SB. However, the safety profile warrants further evaluation, and there is still a lack of high-quality, prospective evidence for the 3TB+6SB schemes. Thus, this randomized controlled trial (RCT) aims to evaluate the efficacy and safety of 3TB+6SB schemes and the routine 3TB+12SB schemes, provide high-quality evidence for the optimization of prostate biopsy schemes.

The main questions it aims to answer are:

Does 3TB+6SB promote the accurate diagnosis of clinically significant prostate cancer? What is the value of 3TB+6SB in improving the safety of prostate biopsy? This prospective RCT compared the csPCa detection rates of 3TB+6SB and 3TB+12SB. Participants were prospectively enrolled at Peking University First Hospital (Beijing, China) from September 2024 to February 2025. Participants were randomly allocated to 3TB+6SB group and 3TB+12SB group.

Researchers will compare the cancer detection rates of 3TB+6SB and 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.

Interventions

• Procedure 3TB+6SB
  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
• Procedure 3TB+12SB
  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

Primary outcome measures

• The clinically significant prostate cancer (csPCa) detection rate [Time frame: One month after the biopsy procedure.]

Secondary outcome measures (7)

• The overall complication rate [Time frame: One week and one month after the biopsy procedure.]
• The self-reported quality of life after the prostate biopsy [Time frame: One week and one month after the biopsy procedure.]
• The operation time of prostate biopsy [Time frame: During the prostate biopsy procedure.]
• The PCa detection rate [Time frame: One month after the biopsy procedure.]
• The clinically insignificant PCa detection rate [Time frame: One month after the biopsy procedure.]
• The Gleason score (GS) of the biopsy sample [Time frame: One month after the biopsy procedure.]
• The GS of radical prostatectomy (RP) specimens [Time frame: One month after the biopsy procedure.]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Diagnostic

Study locations

China · 1 center

• Peking University First Hospital — Beijing

Identifiers

NCT: NCT06684652 · TB+6SB_01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗