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Clinical trial Recruiting at 1 site Interventional Ages 19 and up Men only

Ipsilateral vs Bilateral Biopsy for Prostate Cancer Diagnosis using MRI/Ultrasound Fusion

Official title: A Prospective, Multicenter, Open-Label, Randomized, Parallel-Group, Noninferiority Trial of MRI/Ultrasound Cognitive Fusion Targeted Biopsy Combined With Ipsilateral Versus Bilateral Systematic Biopsy for Prostate Cancer Diagnosis

Run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School · NCT07795723 · Data updated 2026-11-12

This study tests whether taking biopsy samples from only the same side as a MRI-detected lesion is as good as taking samples from both sides in men who are biopsy-naive and have a suspicious unilateral lesion.

Quick facts

Study typeInterventional
Ages19 Years and up
SexMen only
Enrollment454 (estimated)
SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Academic / other
Locations1 site (Nanjing, Jiangsu)
StatusRecruiting
StartedJuly 20, 2026
Main results expectedMarch 2027
Study endsApril 2027
Registry record updatedAugust 31, 2026
Trial IDNCT07795723 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Biopsy-naive men with suspected prostate cancer, unilateral PI-RADS 4-5 lesion on MRI, and PSA ≤ 20 ng/mL who can undergo transperineal biopsy.

Probably not a fit

Patients with bilateral disease, midline lesions, or those who do not meet inclusion criteria may not benefit from the ipsilateral approach.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label trial compares two biopsy strategies added to MRI/US cognitive fusion targeted biopsy in men with suspected prostate cancer. Participants with a unilateral PI-RADS 4-5 lesion and PSA ≤ 20 ng/mL are randomized to receive either a 6-core ipsilateral systematic biopsy or a 12-core bilateral systematic biopsy, alongside targeted sampling. The study is designed to see if the ipsilateral approach is noninferior to the standard bilateral approach in cancer detection while potentially reducing procedure time and burden. Enrollment aims for 454 biopsy-naive men across multiple sites in China. The trial uses transperineal biopsy to collect tissue for pathological assessment.

Why it matters

Potential benefit: If noninferiority is demonstrated, patients may benefit from fewer biopsy cores and potentially fewer complications and discomfort.

How similar studies have gone: Previous MRI/US fusion biopsy studies have shown benefits of targeted sampling; this study tests a streamlined ipsilateral approach in a randomized, noninferiority framework.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
    Nanjing, Jiangsu, China     Recruiting

Study contacts

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.