Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of csPCa: the PROFUSION Trial

NCT06303622 | Recruiting

• 1 other identifier: CRE-2023.610
• Study Type: interventional
• Target: 1,250
• Locations: 1 country
• Sites: 1

Brief Summary

This study is an international multicentre RCT to compare the linically significant prostate cancer (csPCa) detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Proportion of men with clinically significant Prostate cancer(csPCa)

  ISUP Grade 2 or above prostate cancer diagnosed on biopsy

  When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcomes (8)

• Proportion of men with a diagnosis of csPCa in MRI lesions with maximal size ≤10mm versus >10mm

  When histology results available, at an expected average of 30 days post-biopsy

• Proportion of men with a diagnosis of csPCa in prostate size of ≤50ml vs >50m

  When histology results available, at an expected average of 30 days post-biopsy

• The proportion of men with a diagnosis of csPCa only in targeted biopsy

  When histology results available, at an expected average of 30 days post-biopsy

• Proportion of men with a diagnosis of csPCa only in systemic biopsy

  When histology results available, at an expected average of 30 days post-biopsy

• Proportion of men with a diagnosis of clinically insignificant PCa,

  When histology results available, at an expected average of 30 days post-biopsy

Study Arms (2)

MRUS arm

EXPERIMENTAL

Targeted biopsies will be performed by software-assisted MRI-ultrasound fusion registration . Software-based fusion targeted biopsy of 4 cores per target followed by 12-core systematic biopsy will be performed. The fusion or overlay of 3D MRI and USG images create a detailed 3D prostate image with both targeted and systematic biopsy core locations recorded.

Procedure: MRI-USG fusion approach

COG arm

ACTIVE COMPARATOR

The biopsy operator reviews the MR images and creates a mental three-dimensional representation of the prostate and the lesion within it to guide biopsy. Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on transrectal ultrasound (TRUS) corresponding to the MRI suspicious regions. Cognitive-guided biopsy is performed by taking 4 cores from each target followed by 12-core systematic biopsies.

Procedure: Cognitive-guided approach

Interventions

MRI-USG fusion approach PROCEDURE

MRI-USG fusion approach prostate biopsy

MRUS arm

Cognitive-guided approach PROCEDURE

Cognitive-guided approach prostate biopsy

COG arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men ≥18 years of age
• Clinical suspicion of prostate cancer and indicated for prostate biopsy
• Serum Prostate-specific antigen (PSA) \< 20 ng/mL
• Digital rectal examination ≤ cT2 (organ-confined cancer)
• Able to provide written informed consent
• MRI prostate (contrast or plain) showing 1-3 suspicious lesion(s) with PI-RADS score 3-5

You may not qualify if:

• Prior prostate biopsy in the 2 years before screening visit
• Prior diagnosis of prostate cancer
• Contraindicated to prostate biopsy: active urinary tract infection, failed insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (continue low-dose aspirin before and after biopsy is permitted)
• Patient refusal for biopsy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Nanjing Drum Tower Hospital, China: collaborator
• China Medical University Hospital: collaborator
• Center of Postgraduate Medical Education, Poland: collaborator
• Kaohsiung Medical University: collaborator
• Tuen Mun Hospital Hong Kong: collaborator
• Stanford Cancer Institute: collaborator
• Queen Mary Hospital, Hong Kong: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (16)

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• Wong HF, Yee CH, Teoh JY, Chan SY, Chiu PK, Cheung HY, Hou SS, Ng CF. Time trend and characteristics of prostate cancer diagnosed in Hong Kong (China) in the past two decades. Asian J Androl. 2019 Jan 1;21(1):104-106. doi: 10.4103/aja.aja_75_18. No abstract available.

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• Ahdoot M, Wilbur AR, Reese SE, Lebastchi AH, Mehralivand S, Gomella PT, Bloom J, Gurram S, Siddiqui M, Pinsky P, Parnes H, Linehan WM, Merino M, Choyke PL, Shih JH, Turkbey B, Wood BJ, Pinto PA. MRI-Targeted, Systematic, and Combined Biopsy for Prostate Cancer Diagnosis. N Engl J Med. 2020 Mar 5;382(10):917-928. doi: 10.1056/NEJMoa1910038.

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• Chiu PK, Alberts AR, Venderbos LDF, Bangma CH, Roobol MJ. Additional benefit of using a risk-based selection for prostate biopsy: an analysis of biopsy complications in the Rotterdam section of the European Randomized Study of Screening for Prostate Cancer. BJU Int. 2017 Sep;120(3):394-400. doi: 10.1111/bju.13913. Epub 2017 Jun 5.

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• Heidegger I, Pichler R. Re: Peter K.-F. Chiu, Chi-Fai Ng, Axel Semjonow, et al. A Multicentre Evaluation of the Role of the Prostate Health Index (PHI) in Regions with Differing Prevalence of Prostate Cancer: Adjustment of PHI Reference Ranges is Needed for European and Asian Settings. Eur Urol 2019;75:558-61. Eur Urol. 2019 Jun;75(6):e158-e159. doi: 10.1016/j.eururo.2018.12.041. Epub 2019 Jan 5. No abstract available.

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  PMID: 27897172 BACKGROUND

• Turkbey B, Rosenkrantz AB, Haider MA, Padhani AR, Villeirs G, Macura KJ, Tempany CM, Choyke PL, Cornud F, Margolis DJ, Thoeny HC, Verma S, Barentsz J, Weinreb JC. Prostate Imaging Reporting and Data System Version 2.1: 2019 Update of Prostate Imaging Reporting and Data System Version 2. Eur Urol. 2019 Sep;76(3):340-351. doi: 10.1016/j.eururo.2019.02.033. Epub 2019 Mar 18.

  PMID: 30898406 BACKGROUND

• Alberts AR, Roobol MJ, Verbeek JFM, Schoots IG, Chiu PK, Osses DF, Tijsterman JD, Beerlage HP, Mannaerts CK, Schimmoller L, Albers P, Arsov C. Prediction of High-grade Prostate Cancer Following Multiparametric Magnetic Resonance Imaging: Improving the Rotterdam European Randomized Study of Screening for Prostate Cancer Risk Calculators. Eur Urol. 2019 Feb;75(2):310-318. doi: 10.1016/j.eururo.2018.07.031. Epub 2018 Aug 3.

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• Chiu PK, Roobol MJ, Teoh JY, Lee WM, Yip SY, Hou SM, Bangma CH, Ng CF. Prostate health index (PHI) and prostate-specific antigen (PSA) predictive models for prostate cancer in the Chinese population and the role of digital rectal examination-estimated prostate volume. Int Urol Nephrol. 2016 Oct;48(10):1631-7. doi: 10.1007/s11255-016-1350-8. Epub 2016 Jun 27.

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Related Links

• Hong Kong Cancer Statistics

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

Study Officials

• Peter Ka-Fungq CHIU

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ka-Fungq CHIU, PhD

CONTACT

35052625; peterchiu@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: January 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 17, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)