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

NCT06584279 | Recruiting

• 1 other identifier: IUNU-PC-123
• Study Type: observational
• Target: 563
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• additional value of index-lesion-contralaterally systematic biopsy

  0.5-1 years

• pathological upgrade after radical prostatectomy

  0.5-1 years

Study Arms (1)

prostate biopsy

Diagnostic Test: Biopsy of the prostate and pathological diagnosis

Interventions

Biopsy of the prostate and pathological diagnosis DIAGNOSTIC_TEST

Whether the index-lesion-contralateral systematic biopsy was performed

prostate biopsy

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

biopsy-naive men at risk of prostate cancer

You may qualify if:

• 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;

You may not qualify if:

• 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)；

Sponsors & Collaborators

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

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, 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

Central Study Contacts

Hongqian Guo

CONTACT

13605171690; dr.ghq@nju.edu.cn

xuefeng Qiu

CONTACT

13776509416; hydewoods@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: August 31, 2024
• First Posted: September 4, 2024
• Study Start: October 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)