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โ† Trials
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Ipsilateral Versus Bilateral Systematic Biopsy Combined With MRI/Ultrasound Cognitive Fusion Targeted Biopsy for Prostate Cancer Diagnosis

RecruitingNAAges 19 Years - anyMaleThe Affiliated Nanjing Drum Tower Hospital of Nanโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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 det

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Male participants older than 18 years. * Suspected prostate cancer and scheduled to undergo transperineal prostate biopsy. * Prostate MRI showing a unilateral lesion with a highest Prostate Imaging Reporting and Data System (PI-RADS) score of 4 or 5. * Serum prostate-specific antigen (PSA) level of 20 ng/mL or lower. * Able to tolerate and undergo transperineal prostate biopsy. * Willing to participate in the study and able to provide written informed consent. Exclusion Criteria: * Prior prostate biopsy. * Prior prostate-related treatment or procedure that may affect pathological assessment or interpretation of the biopsy results, including but not limited to androgen deprivation therapy for prostate cancer, radiotherapy, focal therapy, or transurethral prostate surgery. * Prostate MRI showing a lesion crossing the prostatic midline such that the lesion side cannot be clearly determined, or an independent contralateral lesion with a PI-RADS score of 3 or higher. * Acute urinary tract infection, severe coagulation disorder, or any other contraindication to transperineal prostate biopsy. * In the investigator's judgment, inability to understand the study, comply with study procedures, or provide written informed consent.
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What it tests

  • MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy
  • MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy
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Where

1 site
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
Nanjing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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