Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy

NCT04685928 | Completed

• 1 other identifier: CRE 2020.569
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 8

Brief 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). 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.

Conditions

Prostate Cancer

Keywords

Prostate biopsy; Prostate Cancer; MRI prostate; Transperineal biopsy

Outcome Measures

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

  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 (7)

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

  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

  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

  30 days post biopsy

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

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

• Cancer core length of the most involved biopsy core

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

Study Arms (2)

MRI arm

EXPERIMENTAL

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

TP-arm Systematic biopsy

ACTIVE COMPARATOR

24-core Systematic transperineal prostate biopsy under local anaesthesia

Diagnostic Test: TP-arm Systematic biopsy

Interventions

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.

MRI arm

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

TP-arm Systematic biopsy

Eligibility Criteria

• Age: 18 Years+
• 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) 4-20 ng/mL
• Digital rectal examination ≤ cT2 (organ confined cancer)
• Able to provide written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (8)

Kwong Wah Hospital

Hong Kong, Hong Kong

Location

North District Hospital

Hong Kong, Hong Kong

Location

Pamela Youde Nethersole Eastern Hospital

Hong Kong, Hong Kong

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Princess Margaret Hospital

Hong Kong, Hong Kong

Location

Queen Elizabeth Hospital

Hong Kong, Hong Kong

Location

Queen Mary Hospital, The University of Hong Kong

Hong Kong, Hong Kong

Location

United Christian Hospital

Hong Kong, Hong Kong

Location

Related Publications (23)

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Related Links

• accessed February 20

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Peter Ka-Fung CHIU, FRCS, PhD

  Prince of Wales Hospital, The Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

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

Model Details: Randomized controlled trial, 1:1 allocation

Study Record Dates

• First Submitted: December 23, 2020
• First Posted: December 28, 2020
• Study Start: May 27, 2021
• Primary Completion: June 3, 2024
• Study Completion: September 24, 2024
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (8)