Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy (SMART)

May 4, 2025 updated by: CHIU Ka Fung Peter, Chinese University of Hong Kong

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

403

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Prince of Wales Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Hong Kong, Hong Kong
        • Queen Elizabeth Hospital
      • Hong Kong, Hong Kong
        • Kwong Wah Hospital
      • Hong Kong, Hong Kong
        • United Christian Hospital
      • Hong Kong, Hong Kong
        • Pamela Youde Nethersole Eastern Hospital
      • Hong Kong, Hong Kong
        • North District Hospital
      • Hong Kong, Hong Kong
        • Queen Mary Hospital, The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men ≥18 years of age
  2. Clinical suspicion of prostate cancer and indicated for prostate biopsy
  3. Serum Prostate-specific antigen (PSA) 4-20 ng/mL
  4. Digital rectal examination ≤ cT2 (organ confined cancer)
  5. Able to provide written informed consent

Exclusion Criteria:

  1. Prior prostate biopsy
  2. Past or current history of prostate cancer
  3. MRI prostate performed within past 5 years
  4. 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)
  5. 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MRI arm
MRI 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.
Diagnostic test: MRI and MRI-guided prostate biopsy
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.
Active Comparator: TP-arm Systematic biopsy
24-core Systematic transperineal prostate biopsy under local anaesthesia
Diagnostic test: TP-arm Systematic biopsy
Transperineal 24-core biopsy using a free-hand technique under local anaesthesia will be performed under transrectal ultrasound guidance for men in this arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
When histology results available, at an expected average of 30 days post-biopsy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
When histology results available, at an expected average of 30 days post-biopsy
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
When MRI results available, at an expected average of 30 days post-MRI
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
30 days post biopsy
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
When histology results available, at an expected average of 30 days post-biopsy
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
When histology results available, at an expected average of 30 days post-biopsy
Health-related Quality of life scores
Time Frame: At recruitment, and at 30 days after intervention
EQ-5D-5L
At recruitment, and at 30 days after intervention
Cost per diagnosis of cancer
Time Frame: 30 days post-biopsy
Cost to diagnosis one cancer
30 days post-biopsy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Peter Ka-Fung CHIU, FRCS, PhD, Prince of Wales Hospital, The Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2021

Primary Completion (Actual)

June 3, 2024

Study Completion (Actual)

September 24, 2024

Study Registration Dates

First Submitted

December 23, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 28, 2020

Study Record Updates

Last Update Posted (Actual)

May 6, 2025

Last Update Submitted That Met QC Criteria

May 4, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE 2020.569

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Clinical Trials on MRI and MRI-guided prostate biopsy

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Peru

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe