Improved biopsy method for diagnosing prostate cancer in men at risk
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
This study is testing a new way to do prostate biopsies to see if it can accurately diagnose cancer while taking fewer samples from men who are at risk and have not had a biopsy before.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 563 (estimated) |
| Ages | 60 Years to 80 Years |
| Sex | Male |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing) |
| Trial ID | NCT06584279 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new biopsy technique called targeted and index-lesion-ipsilateral systematic biopsy for diagnosing clinically significant prostate cancer in men who have not previously undergone biopsy. It compares this method to the conventional biopsy approach to determine if it can maintain diagnostic accuracy while reducing the number of biopsy cores taken. The study is designed as a prospective, multicenter, paired, non-inferiority trial, focusing on men with specific MRI findings indicative of prostate cancer. Participants will undergo both biopsy methods to assess the effectiveness of the new approach.
Who should consider this trial
Good fit: Ideal candidates are men with a PSA level greater than 4 ng/ml and specific MRI findings suggestive of prostate cancer.
Not a fit: Patients with a PSA level over 20 ng/ml or those who have had previous prostate biopsies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less invasive and more efficient method for diagnosing prostate cancer, reducing the number of biopsies needed.
How similar studies have performed: While similar approaches have been explored, this specific method is being investigated for the first time in this context.
Eligibility criteria
Show full inclusion / exclusion 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)；
Where this trial is running
Nanjing
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, China (Recruiting)
Study contacts
- Study coordinator: Hongqian Guo
- Email: dr.ghq@nju.edu.cn
- Phone: 13605171690
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.