Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer

Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer: a Prospective, Multicenter, Paired, Non-inferiority Trial

Targeted and systematic biopsy stands as the prevalent diagnostic approach for prostate cancer. Despite its widespread use, this method is characterized by a high volume of needle biopsies. A refined approach, termed targeted and index-lesion-ipsilateral systematic biopsy, as one of targeted and regional systematic biopsy methods, aim to reduce the number of biopsy cores while maintaining an adequate positive rate. However, the absence of robust evidence necessitates further investigation. This study employs a prospective, multicenter, paired, non-inferiority design to assess the diagnostic efficacy of targeted and index-lesion-ipsilateral systematic prostate biopsy in comparison with the conventional targeted and systematic biopsy for the detection of clinically significant prostate cancer (csPCa). Eligible participants were identified as those with target lesions on prostate MRI, who subsequently underwent targeted and systematic prostate biopsies. The index lesion was defined as the one with the highest Prostate Imaging Reporting and Data System (PI-RADS) score; in cases of multiple lesions with identical PI-RADS scores, the lesion with the greatest diameter was prioritized. Post-biopsy pathological data were collected and evaluated using the International Society of Urological Pathology (ISUP) grading system, which classifies patients with a grade of 2 or higher as having csPCa. The study's primary outcome was to calculate the confidence interval for the difference in csPCa detection rates between the two biopsy methods under a paired design. This interval was then compared against a pre-specified non-inferiority margin to determine whether the targeted and index-lesion-ipsilateral systematic biopsy method is non-inferior to the standard targeted and systematic biopsy in detecting csPCa.

Study Overview

• Status: Recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Diagnostic test: Biopsy of the prostate and pathological diagnosis

• Study Type: Observational
• Enrollment (Estimated): 563

Contacts and Locations

• Study Contact: Name: Xuefeng Qiu; Phone Number: 13776509416; Email: hydewoods@163.com
• Study Contact Backup: Name: Hongqian Guo; Phone Number: 13605171690; Email: dr.ghq@nju.edu.cn

Study Locations

• China
  • Nanjing, China
    • Recruiting
    • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
    • Contact: Hongqian Guo; Phone Number: 13605171690; Email: dr.ghq@nju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

biopsy-naive men at risk of prostate cancer

Description

Inclusion Criteria:

• Prostate specific antigen (PSA) >4 ng/ml;
• Prostate Imaging-Reporting and Data System (PI-RADS) score of any lesions on prostate magnetic resonance imaging ≥4 or PI-RADS score of lesions on prostate magnetic resonance imaging = 3 and prostate specific antigen density ≥0.1ng/cm3;
• accept prostate biopsy;

Exclusion Criteria:

• Prostate specific antigen>20ng/ml；
• the location of index lesion on prostate MRI is on the midline of the prostate and symmetrical on both sides;
• any contraindication of prostate biopsy;
• Previous prostate biopsy；
• Previous history of androgen deprivation therapy (ADT), pelvic radiotherapy, and other treatments；
• Previous history of transurethral prostatectomy (TURP)；

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
prostate biopsy	Diagnostic test: Biopsy of the prostate and pathological diagnosis; Whether the index-lesion-contralateral systematic biopsy was performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Confidence interval for the difference in csPCa detection rate between targeted + index-lesion-ipsilaterally systematic biopsy and targeted + systematic biopsy for biopsy-naive men at risk of prostate cancer	0.5-1 years

Secondary Outcome Measures

Outcome Measure	Time Frame
additional value of index-lesion-contralaterally systematic biopsy	0.5-1 years
pathological upgrade after radical prostatectomy	0.5-1 years

Collaborators and Investigators

• Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: August 31, 2024
• First Submitted That Met QC Criteria: August 31, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: IUNU-PC-123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No