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AzTrials

Prostate CancerSMARTNCT04685928

Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy

A study testing MRI and MRI-guided prostate biopsy and TP-arm Systematic biopsy in people with Prostate Cancer, run by Chinese University of Hong Kong at 8 sites in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-targeted approach (MRI-arm) versus 24-core transperineal (TP) systematic biopsy (TP-arm). 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 and MRI-guided prostate biopsy and TP-arm Systematic biopsy
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
403 participants
Where
8 sitesHong Kong
Study dates
27 May 2021to 24 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

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) 4-20 ng/mL
  • Digital rectal examination ≤ cT2 (organ confined cancer)
  • Able to provide written informed consent

Who cannot join

  • Prior prostate biopsy
  • Past or current history of prostate cancer
  • MRI prostate performed within past 5 years
  • Contraindicated to undergo MRI scan (e.g. pacemaker in-situ, claustrophobia, estimated glomerular filtration rate < 50ml/min in serum renal function test within 3 months)
  • Contraindicated to transperineal prostate biopsy: active urinary tract infection, fail insertion of transrectal ultrasound probe into rectum (abdominal perineal resection, anal stenosis), fail to be placed in lithotomy position, uncorrectable coagulopathy, antiplatelet or anticoagulant which cannot be stopped (keep aspirin before and after biopsy is permitted)

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Hong Kong8 sites

  • Kwong Wah Hospital

    Hong Kong

  • North District Hospital

    Hong Kong

  • Pamela Youde Nethersole Eastern Hospital

    Hong Kong

  • Prince of Wales Hospital

    Hong Kong

  • Princess Margaret Hospital

    Hong Kong

  • Queen Elizabeth Hospital

    Hong Kong

  • Queen Mary Hospital, The University of Hong Kong

    Hong Kong

  • United Christian Hospital

    Hong Kong

Other trials in Hong Kong

About this study

Official title: A Randomized Controlled Trial Comparing Magnetic Resonance Imaging (MRI)-Targeted Biopsy and Extended Transperineal Systematic Biopsy for Detection of Clinically Significant Prostate Cancer: the SMART Trial

This is a randomized controlled trial to evaluate the detection of clinically significant prostate cancer (csPCa) by MRI-targeted approach (MRI-arm) versus 24-core transperineal (TP) systematic biopsy (TP-arm). Clinically significant prostate cancer (csPCa) is defined as ISUP (International Society of Urogenital Pathology) Grade group ≥2 prostate cancer. Patients with elevated PSA 4-20 ng/mL with or without abnormal digital rectal examination (DRE) will be randomized in a 1:1 manner to MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI prostate will be performed for each subject. MRI prostate is considered abnormal if PI-RADS (Prostate Imaging-Reporting and Data System, version 2.1) score is 3, 4 or 5. For subjects in MRI-arm with abnormal MRI, MRI-targeted biopsy will be performed, followed by 12-core systematic transperineal biopsy (sparing MRI-target). For subjects in MRI-arm with normal MRI, no biopsy is performed. For subjects in TP-arm, 24-core systematic transperineal biopsy will be performed without MRI guidance. The study flowchart is provided in Figure 1. The detection rates of csPCa will be compared between MRI-targeted biopsy plus 12-core systematic biopsy (in MRI-arm) versus TP-arm. The study hypothesis is MRI-guided prostate biopsy with 12-core systematic biopsy is superior to 24-core transperineal systematic biopsy in detection of csPCa.

Read the detailed description

The current study is a randomized controlled trial using a superiority design with the subjects randomized in 1:1 manner to either MRI-arm or TP-arm. In the MRI-arm, multiparametric MRI is performed for all subjects. If MRI is abnormal (PI-RADS score 3-5), 3-4 core targeted followed by 12-core systematic transperineal biopsies under local anaesthesia will be performed. If MRI is normal, no biopsy is performed. A 12-core systematic biopsy is also included in MRI-targeted biopsy as it has been shown in the Trio study that adding systematic biopsy increased the detection of csPCa.

In the TP-arm, no MRI will be performed, and all subjects will receive 24-core transperineal prostate biopsy under local anaesthesia. Patient will be followed up in clinic about 30 days after biopsy to review pathology result and complication.

Conditions
Prostate Cancer
Being tested
MRI and MRI-guided prostate biopsy, TP-arm Systematic biopsy
Keywords
Prostate biopsy, Prostate Cancer, MRI prostate, Transperineal biopsy
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 and MRI-guided prostate biopsyDiagnostic test

    Multiparametric MRI prostates in the MRI arm will be performed using 1.5 or 3.0 Tesla scanner with a pelvic phased array coil and contrast injection. T2-weighted, diffusion weighted and dynamic contrast enhanced scans will be included and the reporting of MRI finding will be done according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI-guided targeted biopsy will be performed by Urologists experienced in MRI-guided biopsy for men with PI-RADS score 3-5.

  • TP-arm Systematic biopsyDiagnostic test

    Transperineal 24-core biopsy using a free-hand technique under local anaesthesia will be performed under transrectal ultrasound guidance for men in this arm

Study groups in NCT04685928
Study groupRoleWhat they receive
MRI armExperimentalMRI prostate with contrast, followed by MRI-guided biopsy under local anaesthesia only if MRI show suspicious lesion. Men with non-suspicious MRI will not receive a biopsy.
Receives: Diagnostic Test: MRI and MRI-guided prostate biopsy
TP-arm Systematic biopsyActive comparator24-core Systematic transperineal prostate biopsy under local anaesthesia
Receives: Diagnostic Test: TP-arm Systematic biopsy

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), diagnosis of ISUP Grade group 2 or above prostate cancer in at least 1 biopsy core in MRI-arm Vs TP-arm

    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 (7)

  1. Proportion of men with diagnosis of clinically insignificant prostate cancer (ISUP Grade group 1)

    ISUP Grade 1-5, the higher grade the higher risk.

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

  2. Proportion of men in MRI arm with normal MRI who could avoid a biopsy

    The number of patients in MRI arm with normal MRI

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

  3. 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

  4. Proportion of men with csPCa in MRI-arm (Targeted biopsy only) Vs TP-arm (24-core Systematic 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. Cancer core length of the most involved biopsy core

    maximum cancer core length in mm

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

  6. Health-related Quality of life scores

    EQ-5D-5L

    Measured: At recruitment, and at 30 days after intervention

  7. Cost per diagnosis of cancer

    Cost to diagnosis one cancer

    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 posted28 Dec 2020
  2. Study start27 May 2021
  3. Primary completion3 Jun 2024
  4. Study completion24 Sep 2024

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
Model description
Randomized controlled trial, 1:1 allocation
Masking
None (open label)
Enrolment
403 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04685928
Sponsor's protocol ID
CRE 2020.569
Acronym
SMART
Status last verified
May 2025
First submitted
23 Dec 2020
Last updated
6 May 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Culp MB, Soerjomataram I, Efstathiou JA, Bray F, Jemal A. Recent Global Patterns in Prostate Cancer Incidence and Mortality Rates. Eur Urol. 2020 Jan;77(1):38-52. doi: 10.1016/j.eururo.2019.08.005. Epub 2019 Sep 5.

    PubMed 31493960

  • 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

  • Presti JC Jr, O'Dowd GJ, Miller MC, Mattu R, Veltri RW. Extended peripheral zone biopsy schemes increase cancer detection rates and minimize variance in prostate specific antigen and age related cancer rates: results of a community multi-practice study. J Urol. 2003 Jan;169(1):125-9. doi: 10.1016/S0022-5347(05)64051-7.

    PubMed 12478119

  • Carter HB, Hamper UM, Sheth S, Sanders RC, Epstein JI, Walsh PC. Evaluation of transrectal ultrasound in the early detection of prostate cancer. J Urol. 1989 Oct;142(4):1008-10. doi: 10.1016/s0022-5347(17)38971-1.

    PubMed 2677409

  • 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

  • Chiu PK, Ng CF, Semjonow A, Zhu Y, Vincendeau S, Houlgatte A, Lazzeri M, Guazzoni G, Stephan C, Haese A, Bruijne I, Teoh JY, Leung CH, Casale P, Chiang CH, Tan LG, Chiong E, Huang CY, Wu HC, Nieboer D, Ye DW, Bangma CH, Roobol MJ. 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 Apr;75(4):558-561. doi: 10.1016/j.eururo.2018.10.047. Epub 2018 Nov 2.

    PubMed 30396635

  • 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

  • Loeb S, Vellekoop A, Ahmed HU, Catto J, Emberton M, Nam R, Rosario DJ, Scattoni V, Lotan Y. Systematic review of complications of prostate biopsy. Eur Urol. 2013 Dec;64(6):876-92. doi: 10.1016/j.eururo.2013.05.049. Epub 2013 Jun 4.

    PubMed 23787356

  • Lo KL, Chui KL, Leung CH, Ma SF, Lim K, Ng T, Wong J, Li JKM, Mak SK, Ng CF. Outcomes of transperineal and transrectal ultrasound-guided prostate biopsy. Hong Kong Med J. 2019 Jun;25(3):209-215. doi: 10.12809/hkmj187599. Epub 2019 May 29.

    PubMed 31178436

Questions about this trial

What is this clinical trial studying?

A study testing MRI and MRI-guided prostate biopsy and TP-arm Systematic biopsy in people with Prostate Cancer, run by Chinese University of Hong Kong at 8 sites 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of men with clinically significant Prostate cancer(csPCa), diagnosis of ISUP Grade group 2 or above prostate cancer in at least 1 biopsy core in MRI-arm Vs TP-arm (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 NCT04685928, which also lists 23 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 6 May 2025.

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