Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Official title

MRI-targeted Fusion or Cognitive Ultrasound-guided Biopsy to Detect Prostate Cancer

Overview

The MRI-targeted biopsy for prostate cancer detection can be performed using one of two techniques: 1. Software-based fusion of MRI and ultrasound images (software fusion) or 2. Visually estimated MRI-informed (cognitive fusion) technique To date, there is a lack of adequately powered RCTs directly comparing the cognitive vs fusion targeted biopsy. This randomized study will directly compare the detection rates of clinically significant prostate cancer following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on multi-parametric MRI (mp-MRI) of prostate.

Detailed description

For prostate cancer detection, pre-biopsy multi-parametric magnetic resonance imaging (mp-MRI) followed by MRI-targeted prostate biopsy is standard of care which is supported by the guidelines from the American Urological Association and the European Association of Urology. The MRI-targeted prostate biopsy is associated with a significant increase in the detection of clinically significant prostate cancer (csPCa) compared to the ultrasound guided biopsy. The MRI-targeted biopsy can be performed using one of two techniques including software-based fusion of MRI and ultrasound images (software fusion) or visually guided MRI-informed (cognitive fusion) technique.

With regards to the diagnostic performance in detecting csPCa, current literature does not demonstrate a clear advantage to one targeting technique over the other. A systematic review and meta-analysis (published in early 2024) by Falagario et al evaluated all of the comparative studies of the above-mentioned MRI-targeting techniques. Of the 20 studies included, six reported improved detection of csPCa with fusion technique, one reported an advantage to the cognitive technique, while thirteen reported no significant difference. Of note, the majority of the studies were retrospective, with high risk of bias, that lacked uniform definition of csPCa, and employed variable mp-MRI technique (1.5T vs 3T) and scoring system (Likert vs PIRADS). There were only three small, prospective, randomized studies (RCT) available in the systematic review of literature. One RCT reported the fusion technique to be superior while two demonstrated no difference in csPCa detection rates. There was no significant difference in the detection of csPCa between the targeting techniques, however, low quality of evidence and heterogeneity warranted well-designed prospective studies.

Other studies, as well as personal experience, point to somewhat improved cancer detection the cognitive MRI-targeting approach, although the rates may be affected by patient selection related to lesion size and location.

Thus, the investigators are conducting an RCT to direct compare the csPCa detection rates following either the cognitive or the fusion targeted prostate biopsy in men with suspicious lesions noted on mp-MRI of prostate. The investigators hypothesize that the diagnostic accuracy MRI-targeted prostate biopsy using cognitive fusion technique is either similar to or not significantly inferior to the software fusion technique.

Interventions

• Procedure Software fusion prostate biopsy
  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).
• Procedure Cognitive fusion prostate biopsy
  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).

Primary outcome measures

• Detection of clinically significant prostate cancer [Time frame: 1 year]

Secondary outcome measures (6)

• Detection of clinically significant prostate cancer in the targeted cores, systematic biopsy cores, and combined [Time frame: 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) [Time frame: 1 year]
• Detection of clinically significant prostate cancer at various lesion location (anterior, posterior, apex, base) [Time frame: 1 year]
• Detection rate of overall prostate cancer of any grade [Time frame: 1 year]
• Detection rate of clinically insignificant (low grade) prostate cancer [Time frame: 1 year]
• Detection rate of clinically significant prostate cancer based on PSA density (PSA level / prostate volume) [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Diagnostic

Study locations

United States · 3 centers

• Lahey Clinic, Inc — Burlington
• Albany Medical Center — Albany
• Pennsylvania State University — Hershey

Canada · 1 center

• Manitoba Prostate Centre, CancerCare Manitoba — Winnipeg

Publications

• 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, PMID 29552975
• 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
• 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: PMID 38580833
• 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
• 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.2015.06.00 PMID 26116294
• 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. E PMID 30522912
• 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
• 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 PRE PMID 38212178

Identifiers

NCT: NCT06517901 · 7028

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗