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

NCT ID: NCT06584279

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 563 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-31
• Study Completion Date: 2025-04-30

Brief Summary

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.

Conditions

Prostate Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

prostate biopsy

Biopsy of the prostate and pathological diagnosis

Intervention Type: DIAGNOSTIC_TEST

Whether the index-lesion-contralateral systematic biopsy was performed

Interventions

Biopsy of the prostate and pathological diagnosis

Whether the index-lesion-contralateral systematic biopsy was performed

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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)；

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Hongqian Guo

Role: CONTACT

dr.ghq@nju.edu.cn

13605171690

xuefeng Qiu

Role: CONTACT

hydewoods@163.com

13776509416

Facility Contacts

Hongqian Guo

Role: primary

dr.ghq@nju.edu.cn

13605171690

Other Identifiers

IUNU-PC-123

Identifier Type: -

Identifier Source: org_study_id