Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

NCT06517901 | Recruiting DMC

• 1 other identifier: 7028
• Study Type: interventional
• Target: 1,306
• Locations: 2 countries
• Sites: 4

Brief Summary

The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques:

1. 1.Software-based fusion of MRI and ultrasound images (software fusion) or
2. 2.Visually estimated MRI-informed (cognitive fusion) technique

Conditions

Prostate Cancer; Diagnosis

Keywords

Prostate; Cancer; Biopsy; Diagnosis; MRI

Outcome Measures

Primary Outcomes (1)

• Detection of clinically significant prostate cancer

  Compare the overall detection of clinically significant prostate cancer following fusion vs cognitive MRI-targeted biopsy

  1 year

Secondary Outcomes (6)

• Detection of clinically significant prostate cancer in the targeted cores, systematic biopsy cores, and combined

  1 year

• Detection of clinically significant prostate cancer based on lesion size (< 0.5 cm; 0.5 cm to 1 cm; > 1.1 cm etc)

  1 year

• Detection of clinically significant prostate cancer at various lesion location (anterior, posterior, apex, base)

  1 year

• Detection rate of overall prostate cancer of any grade

  1 year

• Detection rate of clinically insignificant (low grade) prostate cancer

  1 year

Study Arms (2)

Software fusion biopsy

ACTIVE COMPARATOR

Software fusion biopsy: Biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar.

Procedure: Software fusion prostate biopsy

Cognitive fusion biopy

EXPERIMENTAL

Cognitive fusion biopsy: Biopsy of the MRI-detected lesion using visual estimation and/or measurements to identify landmarks and lesions.

Procedure: Cognitive fusion prostate biopsy

Interventions

Software fusion prostate biopsy PROCEDURE

Software fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using an image fusion platform such as UroNav or similar. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).

Software fusion biopsy

Cognitive fusion prostate biopsy PROCEDURE

Cognitive fusion biopsy: Each participant in this study arm will first undergo biopsy of the MRI-detected lesion using visual estimation and/or measurements of lesion. Three biopsy cores will be taken per lesion, with a maximum of three lesions being sampled per participant. Then systematic samples will be taken from the remainder of the prostate as per standard protocol (10-12 cores).

Also known as: Visual estimation fusion prostate biopsy

Cognitive fusion biopy

Eligibility Criteria

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

You may qualify if:

• Men undergoing prostate biopsy (either transrectal or transperineal) for suspected prostate cancer as part of their regular medical care
• Must be eligible to undergo both prostate biopsy procedure (cognitive or fusion)
• Men undergoing their first prostate biopsy procedure or with no previous prostate biopsy within 3 years
• Pre-biopsy mp-MRI of prostate with one or more lesions classified as PIRADS 3-5
• Largest dimension of any lesion on mp-MRI to be ≤ 2 cm
• Prostate-specific antigen level ≤ 20 ng/mL and/or abnormal digital rectal examination

You may not qualify if:

• mp-MRI detected lesions that are \> 2 cm
• History of prostate biopsy within 3 years
• Previous diagnosis of prostate cancer
• Contraindications to prostate biopsy (eg, fever, evidence of genito-urinary infection, excessive co-morbidities as per treating physician)

Sponsors & Collaborators

• Albany Medical College: lead

Study Sites (4)

Lahey Clinic, Inc

Burlington, Massachusetts, 01805, United States

RECRUITING

Albany Medical Center

Albany, New York, 12208, United States

RECRUITING

Pennsylvania State University

Hershey, Pennsylvania, 17023, United States

NOT YET RECRUITING

Manitoba Prostate Centre, CancerCare Manitoba

Winnipeg, Manitoba, R3A 1M5, Canada

NOT YET RECRUITING

Related Publications (10)

• Kasivisvanathan V, Rannikko AS, Borghi M, Panebianco V, Mynderse LA, Vaarala MH, Briganti A, Budaus L, Hellawell G, Hindley RG, Roobol MJ, Eggener S, Ghei M, Villers A, Bladou F, Villeirs GM, Virdi J, Boxler S, Robert G, Singh PB, Venderink W, Hadaschik BA, Ruffion A, Hu JC, Margolis D, Crouzet S, Klotz L, Taneja SS, Pinto P, Gill I, Allen C, Giganti F, Freeman A, Morris S, Punwani S, Williams NR, Brew-Graves C, Deeks J, Takwoingi Y, Emberton M, Moore CM; PRECISION Study Group Collaborators. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis. N Engl J Med. 2018 May 10;378(19):1767-1777. doi: 10.1056/NEJMoa1801993. Epub 2018 Mar 18.

  PMID: 29552975 BACKGROUND

• Siddiqui MM, Rais-Bahrami S, Turkbey B, George AK, Rothwax J, Shakir N, Okoro C, Raskolnikov D, Parnes HL, Linehan WM, Merino MJ, Simon RM, Choyke PL, Wood BJ, Pinto PA. Comparison of MR/ultrasound fusion-guided biopsy with ultrasound-guided biopsy for the diagnosis of prostate cancer. JAMA. 2015 Jan 27;313(4):390-7. doi: 10.1001/jama.2014.17942.

  PMID: 25626035 BACKGROUND

• Falagario UG, Pellegrino F, Fanelli A, Guzzi F, Bartoletti R, Cash H, Pavlovich C, Emberton M, Carrieri G, Giannarini G. Prostate cancer detection and complications of MRI-targeted prostate biopsy using cognitive registration, software-assisted image fusion or in-bore guidance: a systematic review and meta-analysis of comparative studies. Prostate Cancer Prostatic Dis. 2025 Jun;28(2):270-279. doi: 10.1038/s41391-024-00827-x. Epub 2024 Apr 5.

  PMID: 38580833 BACKGROUND

• Izadpanahi MH, Elahian A, Gholipour F, Khorrami MH, Zargham M, Mohammadi Sichani M, Alizadeh F, Khorrami F. Diagnostic yield of fusion magnetic resonance-guided prostate biopsy versus cognitive-guided biopsy in biopsy-naive patients: a head-to-head randomized controlled trial. Prostate Cancer Prostatic Dis. 2021 Dec;24(4):1103-1109. doi: 10.1038/s41391-021-00366-9. Epub 2021 Apr 27.

  PMID: 33907293 BACKGROUND

• Arsov C, Rabenalt R, Blondin D, Quentin M, Hiester A, Godehardt E, Gabbert HE, Becker N, Antoch G, Albers P, Schimmoller L. Prospective randomized trial comparing magnetic resonance imaging (MRI)-guided in-bore biopsy to MRI-ultrasound fusion and transrectal ultrasound-guided prostate biopsy in patients with prior negative biopsies. Eur Urol. 2015 Oct;68(4):713-20. doi: 10.1016/j.eururo.2015.06.008. Epub 2015 Jun 23.

  PMID: 26116294 BACKGROUND

• Wegelin O, Exterkate L, van der Leest M, Kummer JA, Vreuls W, de Bruin PC, Bosch JLHR, Barentsz JO, Somford DM, van Melick HHE. The FUTURE Trial: A Multicenter Randomised Controlled Trial on Target Biopsy Techniques Based on Magnetic Resonance Imaging in the Diagnosis of Prostate Cancer in Patients with Prior Negative Biopsies. Eur Urol. 2019 Apr;75(4):582-590. doi: 10.1016/j.eururo.2018.11.040. Epub 2018 Dec 3.

  PMID: 30522912 BACKGROUND

• Mian BM, Feustel PJ, Aziz A, Kaufman RP Jr, Bernstein A, Fisher HAG. Clinically Significant Prostate Cancer Detection Following Transrectal and Transperineal Biopsy: Results of the Prostate Biopsy Efficacy and Complications Randomized Clinical Trial. J Urol. 2024 Jul;212(1):21-31. doi: 10.1097/JU.0000000000003979. Epub 2024 May 3.

  PMID: 38700844 BACKGROUND

• Hu JC, Assel M, Allaf ME, Ehdaie B, Vickers AJ, Cohen AJ, Ristau BT, Green DA, Han M, Rezaee ME, Pavlovich CP, Montgomery JS, Kowalczyk KJ, Ross AE, Kundu SD, Patel HD, Wang GJ, Graham JN, Shoag JE, Ghazi A, Singla N, Gorin MA, Schaeffer AJ, Schaeffer EM. Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted and Systematic Prostate Biopsy to Prevent Infectious Complications: The PREVENT Randomized Trial. Eur Urol. 2024 Jul;86(1):61-68. doi: 10.1016/j.eururo.2023.12.015. Epub 2024 Jan 11.

  PMID: 38212178 BACKGROUND

• Ploussard G, Barret E, Fiard G, Lenfant L, Malavaud B, Giannarini G, Almeras C, Aziza R, Renard-Penna R, Descotes JL, Rozet F, Beauval JB, Salin A, Roupret M. Transperineal Versus Transrectal Magnetic Resonance Imaging-targeted Biopsies for Prostate Cancer Diagnosis: Final Results of the Randomized PERFECT trial (CCAFU-PR1). Eur Urol Oncol. 2024 Oct;7(5):1080-1087. doi: 10.1016/j.euo.2024.01.019. Epub 2024 Feb 24.

  PMID: 38403523 BACKGROUND

• Ortner G, Mavridis C, Fritz V, Schachtner J, Mamoulakis C, Nagele U, Tokas T. The Added Value of MRI-Based Targeted Biopsy in Biopsy-Naive Patients: A Propensity-Score Matched Comparison. J Clin Med. 2024 Feb 27;13(5):1355. doi: 10.3390/jcm13051355.

  PMID: 38592166 BACKGROUND

Related Links

• American Urological Association guidelines
• European Association for Urology guidelines

MeSH Terms

Conditions

Prostatic Neoplasms; Disease; Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Badar M Mian, MD

  Albany Medical College

  STUDY CHAIR

Central Study Contacts

Badar M Mian, MD

CONTACT

5182623296; mianb@amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: April 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1); US (3)