Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
Prostate biopsy usually combines magnetic resonance imaging/ultrasound (MRI/US) cognitive fusion targeted biopsy with systematic biopsy. Standard bilateral systematic biopsy requires sampling from both sides of the prostate and may increase the number of biopsy cores, procedural discomfort, procedure time, pathological workload, and biopsy-related complications. This prospective, multicenter, open-label, randomized noninferiority trial will enroll 454 biopsy-naive men with suspected prostate cancer, a unilateral prostate MRI lesion with a highest PI-RADS score of 4 or 5, and prostate-specific antigen levels of 20 ng/mL or lower. Participants will be randomly assigned in a 1:1 ratio to receive transperineal MRI/US cognitive fusion targeted biopsy combined with either a 6-core ipsilateral systematic biopsy or a standard 12-core bilateral systematic biopsy. The primary objective is to determine whether the ipsilateral systematic biopsy strategy is noninferior to the bilateral systematic biopsy strategy for detecting clinically significant prostate cancer, defined as International Society of Urological Pathology Grade Group 2 or higher. The study will also compare overall prostate cancer detection, biopsy core numbers, pain and discomfort, procedure time, pathological workload and costs, urinary symptoms, quality of life, and biopsy-related adverse events and complications through 30 days after biopsy.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Mężczyźni powyżej 18 lat
- •Podejrzenie raka prostaty i zaplanowana biopsja
- •Wynik rezonansu magnetycznego pokazujący zmianę po jednej stronie prostaty (wysokie wyniki w skali PI-RADS: 4 lub 5)
- •Poziom PSA w krwi 20 ng/mL lub niżej
- •Możliwość przejścia biopsję przez skórę między genitaliami a odbytnicą
- •Chęć uczestnictwa i podpisanie zgody na udział w badaniu
✗ Disqualifies
- •Wcześniejsza biopsja prostaty
- •Wcześniejsze leczenie prostaty (hormony, promieniowanie, zabiegi chirurgiczne)
- •Zmiana w rezonansie magnetycznym położona po obu stronach prostaty lub niezależna zmiana po drugiej stronie
- •Świeża infekcja dróg moczowych lub zaburzenia krzepnięcia krwi
- •Zdaniem lekarza: niemożność zrozumienia badania lub wykonania procedury
Simplified criteria — AI translation
Trial details
- Minimum age
- 19 Years
- Last updated (source)
- August 31, 2026
- Sex
- Male only
Therapies / drugs in trial
Locations (1)
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
Trial contact
Haifeng Huang
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/1/2026.
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