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Prostate CancerNCT06303622

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

A study testing MRI-USG fusion approach and Cognitive-guided approach in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Prostate Cancer
What is being tested?
MRI-USG fusion approach and Cognitive-guided approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,620 participants
Where
1 siteHong Kong
Study dates
8 Jan 2025to 31 Mar 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Peter Ka-Fungq CHIU, PhD contact

35052625

peterchiu@surgery.cuhk.edu.hk

Hong Kong1 site, 1 recruiting

  • Prince of Wales Hospital

    Hong Kong

    Ka Fung Peter CHIU, FRCS, PhD, peterchiu@surgery.cuhk.edu.hk

    Recruiting

Other trials in Hong Kong

About this study

Official title: A Randomised Controlled Trial Comparing MRI-Ultrasound Fusion and Cognitive-guided Biopsy for the Detection of Clinically Significant Prostate Cancer: the PROFUSION Trial

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.

Read the detailed description

This study is an international multicentre RCT to compare the csPCa detection of cognitive-guided and MRI-USG guided biopsies in men with suspicious MRI lesion. This is a phase III randomised controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-USG fusion approach (MRUS arm) versus Cognitive-guided approach (COG arm). The study hypothesis is that MRUS arm is superior to COG arm in detecting csPCa. The result of this RCT would impact how MRI-guided prostate biopsies should be done in the future. If the MRI-USG fusion approach is superior to cognitive-guidance in csPCa detection, it should be the standard of practice in the future, and dedicated MRI-USG fusion equipment should be available in centres performing prostate biopsies.

Conditions
Prostate Cancer
Being tested
MRI-USG fusion approach, Cognitive-guided approach
Medical subject headings
Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MRI-USG fusion approachProcedure or surgery

    MRI-USG fusion approach prostate biopsy

  • Cognitive-guided approachProcedure or surgery

    Cognitive-guided approach prostate biopsy

Study groups in NCT06303622
Study groupRoleWhat they receive
MRUS armExperimentalTargeted 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.
Receives: Procedure: MRI-USG fusion approach
COG armActive comparatorThe 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.
Receives: Procedure: Cognitive-guided approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of men with clinically significant Prostate cancer(csPCa)

    ISUP Grade 2 or above prostate cancer diagnosed on biopsy

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

Secondary outcomes (8)

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

    MRI lesions with maximal size ≤10mm versus >10mm

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

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

    prostate size of ≤50ml vs >50ml

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

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

    ISUP Grade 2 or above prostate cancer diagnosed on biopsy

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

  4. Proportion of men with a diagnosis of csPCa only in systemic biopsy

    ISUP Grade 2 or above prostate cancer diagnosed on biopsy

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

  5. Proportion of men with a diagnosis of clinically insignificant PCa,

    ISUP grade group 1 Prostate cancer diagnosed on biopsy

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

  6. Procedure time

    Total time of procedure

    Measured: During biopsy procedure

  7. Pain score on a scale of 0-10 taken after biopsy

    The higher the score, the more pain

    Measured: Immediately After biopsy procedure

  8. Proportion of men with post-biopsy adverse events within 30 days after biopsy

    The severity of Adverse event is grade by Clavien-Dindo classification

    Measured: 30 days post biopsy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start8 Jan 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,620 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06303622
Sponsor's protocol ID
CRE-2023.610
Status last verified
Oct 2026
First submitted
5 Mar 2024
Last updated
27 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Chan SY, Ng CF, Lee KW, Yee CH, Chiu PK, Teoh JY, Hou SS. Differences in cancer characteristics of Chinese patients with prostate cancer who present with different symptoms. Hong Kong Med J. 2017 Feb;23(1):6-12. doi: 10.12809/hkmj164875. Epub 2016 Dec 9.

    PubMed 27932742

  • 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.

    PubMed 30178778

  • Patasius A, Smailyte G. Re: MaryBeth B. Culp, Isabelle Soerjomataram, Jason A. Efstathiou, Freddie Bray, Ahmedin Jemal. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol 2020;77:38-52. Eur Urol. 2020 May;77(5):e132. doi: 10.1016/j.eururo.2019.11.030. Epub 2019 Dec 13. No abstract available.

    PubMed 31843337

  • 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.

    PubMed 32130814

  • 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.

    PubMed 28498624

  • 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.

    PubMed 30616947

  • Chiu PK, Roobol MJ, Nieboer D, Teoh JY, Yuen SK, Hou SM, Yiu MK, Ng CF. Adaptation and external validation of the European randomised study of screening for prostate cancer risk calculator for the Chinese population. Prostate Cancer Prostatic Dis. 2017 Mar;20(1):99-104. doi: 10.1038/pcan.2016.57. Epub 2016 Nov 29.

    PubMed 27897172

  • 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.

    PubMed 30898406

  • 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.

    PubMed 30082150

  • Drost FH, Osses DF, Nieboer D, Steyerberg EW, Bangma CH, Roobol MJ, Schoots IG. Prostate MRI, with or without MRI-targeted biopsy, and systematic biopsy for detecting prostate cancer. Cochrane Database Syst Rev. 2019 Apr 25;4(4):CD012663. doi: 10.1002/14651858.CD012663.pub2.

    PubMed 31022301

  • Ahmed HU, El-Shater Bosaily A, Brown LC, Gabe R, Kaplan R, Parmar MK, Collaco-Moraes Y, Ward K, Hindley RG, Freeman A, Kirkham AP, Oldroyd R, Parker C, Emberton M; PROMIS study group. Diagnostic accuracy of multi-parametric MRI and TRUS biopsy in prostate cancer (PROMIS): a paired validating confirmatory study. Lancet. 2017 Feb 25;389(10071):815-822. doi: 10.1016/S0140-6736(16)32401-1. Epub 2017 Jan 20.

    PubMed 28110982

  • 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.

    PubMed 29552975

  • Connor MJ, Gorin MA, Eldred-Evans D, Bass EJ, Desai A, Dudderidge T, Winkler M, Ahmed HU. Landmarks in the evolution of prostate biopsy. Nat Rev Urol. 2023 Apr;20(4):241-258. doi: 10.1038/s41585-022-00684-0. Epub 2023 Jan 18.

    PubMed 36653670

  • 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.

    PubMed 27349564

Questions about this trial

What is this clinical trial studying?

A study testing MRI-USG fusion approach and Cognitive-guided approach in people with Prostate Cancer, run by Chinese University of Hong Kong at 1 site in Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Peter Ka-Fungq CHIU, PhD (35052625, peterchiu@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of men with clinically significant Prostate cancer(csPCa) (time frame: When histology results available, at an expected average of 30 days post-biopsy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06303622, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.

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