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

NCT07795723 | Recruiting DMC

• 2 other identifiers: IUNU-PC-1312026-0723-02
• Study Type: interventional
• Target: 454
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Keywords

Prostate Biopsy; MRI-Targeted Biopsy; Cognitive Fusion Biopsy; Transperineal Prostate Biopsy; Systematic Biopsy; Ipsilateral Systematic Biopsy; Bilateral Systematic Biopsy; Clinically Significant Prostate Cancer; PI-RADS; Noninferiority Trial

Outcome Measures

Primary Outcomes (1)

• Detection Rate of Clinically Significant Prostate Cancer

  The proportion of participants with clinically significant prostate cancer detected by the assigned biopsy strategy. Clinically significant prostate cancer is defined as biopsy pathology showing International Society of Urological Pathology (ISUP) Grade Group 2 or higher. The between-group risk difference will be calculated as TB+iSB minus TB+SB. Noninferiority will be concluded if the lower bound of the two-sided 95% confidence interval is greater than -15%.

  Day 14 after biopsy

Secondary Outcomes (14)

• Overall Prostate Cancer Detection Rate

  Day 14 after biopsy

• Clinically Insignificant Prostate Cancer Detection Rate

  Day 14 after biopsy

• High-Grade Prostate Cancer Detection Rate

  Day 14 after biopsy

• Pain Numeric Rating Scale Score

  Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent pain

• Overall Discomfort Numeric Rating Scale Score

  Within 30 minutes after biopsy and at 24 hours after biopsy; additionally at day 7 (±2 days) among participants with persistent discomfort

Other Outcomes (2)

• Real-Time Ultrasound Visibility of MRI-Suspicious Lesions

  During MRI/ultrasound cognitive fusion targeted biopsy

• ISUP Grade Group Concordance Between Biopsy and Radical Prostatectomy Pathology

  Up to 6 months after biopsy

Study Arms (2)

TB+iSB

EXPERIMENTAL

Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion. Targeted biopsy will be followed by a 6-core ipsilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on the MRI lesion side. Local anesthesia will be administered only on the MRI lesion side.

Procedure: MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy

TB+SB

ACTIVE COMPARATOR

Participants will undergo transperineal MRI/ultrasound cognitive fusion targeted biopsy of all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 targeted cores obtained from each lesion. Targeted biopsy will be followed by a standard 12-core bilateral systematic biopsy covering the medial and lateral regions of the base, midgland, and apex on both sides of the prostate. Bilateral local anesthesia will be administered.

Procedure: MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy

Interventions

MRI/US Cognitive Fusion Targeted Biopsy Plus Ipsilateral Systematic Biopsy PROCEDURE

Transperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a 6-core systematic biopsy limited to the MRI lesion side, sampling the medial and lateral regions of the base, midgland, and apex. Local anesthesia will be limited to the MRI lesion side.

TB+iSB

MRI/US Cognitive Fusion Targeted Biopsy Plus Bilateral Systematic Biopsy PROCEDURE

Transperineal MRI/ultrasound cognitive fusion targeted biopsy will be performed for all PI-RADS 3 or higher lesions on the MRI lesion side, with 3 cores obtained from each lesion. This will be followed by a standard 12-core bilateral systematic biopsy sampling the medial and lateral regions of the base, midgland, and apex on both sides of the prostate. Bilateral local anesthesia will be administered.

TB+SB

Eligibility Criteria

• Age: 19 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead
• Huai'an First People's Hospital: collaborator
• Northern Jiangsu People's Hospital: collaborator
• Beijing Hospital: collaborator
• The First People's Hospital of Changzhou: collaborator
• Nantong First People's Hospital: collaborator

Study Sites (1)

Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

RECRUITING

Related Publications (1)

• Cheng Y, Huang H, Wang M, Zhu L, Peng S, Li D, Marra G, Qi R, Ding X, Liu M, Qiu X, Guo H. Magnetic resonance imaging-targeted biopsy with index lesion ipsilateral or bilateral systematic biopsy in prostate cancer: A multicenter, paired, noninferiority, observational trial. Cancer. 2026 Jul 1;132(13):e70493. doi: 10.1002/cncr.70493.

  PMID: 42319125 RESULT

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Haifeng Huang

CONTACT

+86-186-5165-8099; 24083491@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants and biopsy operators are not masked because the two groups differ in the systematic biopsy template, number of biopsy cores, sampling extent, and extent of local anesthesia. Pathologists and core outcome assessors will remain unaware of study-group allocation whenever feasible. Statistical analyses will be performed using coded group labels whenever feasible.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be stratified by the highest PI-RADS score (PI-RADS 4 or PI-RADS 5) and randomly assigned in a 1:1 ratio to one of two parallel biopsy strategy groups: MRI/ultrasound cognitive fusion targeted biopsy plus ipsilateral 6-core systematic biopsy, or MRI/ultrasound cognitive fusion targeted biopsy plus standard bilateral 12-core systematic biopsy.

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 31, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-07

Locations

CN (1)