Extended Systematic Versus Mri-Assisted pRostate Transperineal Biopsy

Prostate Cancer Clinical Trial

— SMART  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04685928
• Other study ID #: CRE 2020.569
• Status: Recruiting
• Phase: N/A
• Start date: May 27, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: January 2024
• Source: Chinese University of Hong Kong
• Contact: Peter Ka-Fung CHIU, FRCS, PhD
• Phone: 3505-2625
• Email: peterchiu[@]surgery.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• 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

Locations

Country	Name	City	State
Hong Kong	Kwong Wah Hospital	Hong Kong
Hong Kong	North District Hospital	Hong Kong
Hong Kong	Pamela Youde Nethersole Eastern Hospital	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	Queen Mary Hospital, The University of Hong Kong	Hong Kong
Hong Kong	United Christian Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (23)

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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. — View Citation

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. — View Citation

Chiu PK, Lo KL, Teoh JY, Ma SF, Leung CH, Wong HF, Li KM, Sae-Lo K, Kwok SW, Li SY, Yee CH, Hou SM, Ng CF. Sectoral cancer detection and tolerability of freehand transperineal prostate biopsy under local anaesthesia. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):431-438. doi: 10.1038/s41391-020-00293-1. Epub 2020 Sep 30. — View Citation

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. — View Citation

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. — View Citation

Chiu PK, Teoh JY, Lee WM, Yee CH, Chan ES, Hou SM, Ng CF. Extended use of Prostate Health Index and percentage of [-2]pro-prostate-specific antigen in Chinese men with prostate specific antigen 10-20 ng/mL and normal digital rectal examination. Investig Clin Urol. 2016 Sep;57(5):336-42. doi: 10.4111/icu.2016.57.5.336. Epub 2016 Aug 31. — View Citation

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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. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of men with diagnosis of clinically insignificant prostate cancer (ISUP Grade group 1)	ISUP Grade 1-5, the higher grade the higher risk.	When histology results available, at an expected average of 30 days post-biopsy
Secondary	Proportion of men in MRI arm with normal MRI who could avoid a biopsy	The number of patients in MRI arm with normal MRI	When MRI results available, at an expected average of 30 days post-MRI
Secondary	Proportion of men with post-biopsy adverse events within 30 days after biopsy	The severity of Adverse event is grade by Clavien-Dindo classification	30 days post biopsy
Secondary	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	When histology results available, at an expected average of 30 days post-biopsy
Secondary	Cancer core length of the most involved biopsy core	maximum cancer core length in mm	When histology results available, at an expected average of 30 days post-biopsy
Secondary	Health-related Quality of life scores	EQ-5D-5L	At recruitment, and at 30 days after intervention
Secondary	Cost per diagnosis of cancer	Cost to diagnosis one cancer	30 days post-biopsy

External Links

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