Status:
RECRUITING
Diagnostic Value of MRI-targeted Plus Index-lesion-ipsilaterally Systematic Biopsy for Biopsy-naive Men At Risk of Prostate Cancer
Lead Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Conditions:
Prostate Cancer
Eligibility:
MALE
60-80 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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)；
Key Trial Info
Start Date :
October 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
563 Patients enrolled
Trial Details
Trial ID
NCT06584279
Start Date
October 1 2024
End Date
April 1 2025
Last Update
October 24 2024
Active Locations (1)
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1
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, China