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NCT Number: NCT04685928

Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Kwong Wah Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

MRI and MRI-guided prostate biopsy

Diagnostic 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 biopsy

Diagnostic 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

Primary outcomes

  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

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

    ISUP Grade 2 or above prostate cancer diagnosed on biopsy

Secondary outcomes

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

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

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

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

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

    The number of patients in MRI arm with normal MRI

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

    Time frame: 30 days post biopsy

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

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

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

    ISUP Grade 2 or above prostate cancer diagnosed on biopsy

  5. Cancer core length of the most involved biopsy core

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

    maximum cancer core length in mm

  6. Health-related Quality of life scores

    Time frame: At recruitment, and at 30 days after intervention

    EQ-5D-5L

  7. Cost per diagnosis of cancer

    Time frame: 30 days post-biopsy

    Cost to diagnosis one cancer

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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

Acronym: SMART

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 28, 2020
Registry last updated
May 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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