NCT06482645

Brief Summary

The goal of this multicenter randomized controlled trial (RCT) is to evaluate the efficacy and safety of different prostate biopsy schemes, including perilesional/regional systematic biopsy (PB/RSB) and combination of systematic biopsy and targeted biopsy (TB+SB). The main questions it aims to answer are: Does PB/RSB promote the accurate diagnosis of clinically significant prostate cancer? What's the value of PB/RSB in improving the safety of prostate biopsy? Researchers will compare the cancer detection rates of PB/RSB and combination of TB+SB 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 PB/RSB or TB+SB.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
1mo left

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress95%
Jul 2024Jun 2026

First Submitted

Initial submission to the registry

June 25, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

July 23, 2024

Status Verified

July 1, 2024

Enrollment Period

12 months

First QC Date

June 25, 2024

Last Update Submit

July 19, 2024

Conditions

Prostate Cancer

Keywords

Prostate cancerMulticenter randomized controlled trialPerilesional biopsyRegional 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 (6)

  • 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 Gleason score (GS) of the biopsy sample

    One month after the biopsy procedure.

  • +1 more secondary outcomes

Study Arms (2)

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). The location of these nine cores depended on the shape and location of the suspicious lesion.

Procedure: Perilesional/regional systematic biopsy

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

EXPERIMENTAL

For patients in the TB+SB group, three to five targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core biopsy.

Procedure: Combination of systematic biopsy and targeted biopsy

Interventions

Perilesional/regional systematic biopsyPROCEDURE

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. For each predefined mpMRI suspicious lesion, urologists obtained nine cores at 5-mm intervals within and around the region of interest (penumbra). The location of these nine cores depended on the shape and location of the suspicious lesion.

Perilesional/regional systematic biopsy (PB/RSB) group
Combination of systematic biopsy and targeted biopsyPROCEDURE

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. Three to five targeted biopsies from the lesion were performed within and around the predefined mpMRI suspicious lesion, followed by fore-zone 12-core biopsy.

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

Eligibility Criteria

Age45 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (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 \> 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 \< 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Yi LIU

    Peking University First Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi LIU

CONTACT

+86 13611035261liuyipkuhsc@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

June 30, 2025

Study Completion (Estimated)

June 30, 2026

Last Updated

July 23, 2024

Record last verified: 2024-07

Locations

CN(1)