US/MRI Fusion Local Anestesia TransPerineal Prostate Biopsies for Detection of Prostate Cancer

NCT04797078 | Withdrawn

• 1 other identifier: STHLM3FLAPP
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

We are conducting a randomised trial comparing outcomes of transperineal prostate biopsies under free-hand software assisted MRI/US fusion with transrectal biopsy guide software assisted MRI/US fusion. Primary outcome is the detection of clinically significant prostate cancer. Secondary outcomes is rate of complications including infection and sepsis, as well as feasibility and patient tolerability.

Conditions

Prostate Cancer

Keywords

transperineal biopsy; prostate cancer detection

Outcome Measures

Primary Outcomes (1)

• Rate of prostate cancer detection

  Detection of clinically significant prostate cancer (defined as any ISUP \>2). Per PIRADS grade group.

  Data available at completed inclusion

Secondary Outcomes (2)

• Rate of urinary tract infection and sepsis

  Data available at completed inclusion + 30 days

• Individual complications requiring hospital admission.

  Data available at completed inclusion + 30 days

Other Outcomes (2)

• Patient tolerability

  Data available at completed inclusion + 30 days

• Outcomes after radical prostatectomy

  1 yr after study inclusion closes

Study Arms (2)

Transrectal fusion biopsies of the prostate

ACTIVE COMPARATOR

1. Transrectal approach, patient in left lateral position, local anestesia 10ml lidocaine 1% at prostate base laterally and apex if indicated. 2. MRI-ultrasound fusion-guided biopsies with 4 biopsy cores per lesion, where clinically indicated. 18G biopsy needle. 3. Standard 12-core template for systematic biopsies. 18G biopsy needle. 4. Antibiotic prophylaxis with 750mg ciprofloxaicin, single dose p.o.

Procedure: Transrectal biopsy

Transperineal free hand fusion biopsies of the prostate

EXPERIMENTAL

Men randomized to the experimental arm undergoes free-hand targeted transperineal fusion biopsies as defined below. 1. Patient is placed supine in the lithotomy-position. The perineal area is prepared with chlorhexidine 0,5ml/ml. 2. Ropivacain 7,5mg/ml is used as an anesthetic agent. Up to 40ml's (equivalent to 300mg) can be used to anestitize the skin, caudal and cranial part of the urogenital diaphragm and periprostatic tissue. 3. Free-hand MRI-ultrasound fusion-guided biopsies with at least 4 biopsy cores per lesion. Coaxial technique with 18G biopsy needle. 4. 10-12 Systematic biopsies according to the modified Barzell 12-core template. 5. No antibiotic profylaxis unless warranted by immunosuppression, previous sepsis or urinary tract infection.

Procedure: Transperineal biopsy

Interventions

Transperineal biopsy PROCEDURE

Transperineal free hand MRI-US fusion prostate biopsy

Transperineal free hand fusion biopsies of the prostate

Transrectal biopsy PROCEDURE

Transrectal MRI-US fusion prostate biopsy

Transrectal fusion biopsies of the prostate

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed written informed consent to participate
• Be aged 18 years and over
• An understanding of the Swedish language sufficient to understand written and verbal information about the trial and consent process
• Be suited and fit for either procedure (transrectal/transperineal)
• Be suitable for a prostate biopsy and clinically due to have a biopsy for diagnostic purpose (following indications for biopsy)
• Biopsy naïve
• Men on active surveillance (AS)
• Rebiopsy
• Be willing and able to comply with scheduled visits and completion of study questionnaires

You may not qualify if:

• Severe illness such as metastatic cancers, sever cardio-vascular disease or dementia
• Men with contraindication for a prostate biopsy
• Men without suspect lesions on MRI
• Previous TURP or other BPH treatment (HoLEP, PostaLUND, water-vaporization) is permitted, but men who have had HIFU, cryo, IRE (irreversible electroporation), photodynamic, or microwave therapy to the prostate will not be included.
• Previous treatment with BCG for bladder cancer
• Men who are unable to undergo transrectal ultrasonography
• Men who have had previous radiation therapy to the pelvis
• Men not tolerating ciprofloxacin
• Unable to lie down with legs in a stirrup for at least 45 minutes, as assessed by a clinician

Sponsors & Collaborators

• Karolinska Institutet: lead
• Capio Sankt Görans Hospital: collaborator
• GHP Urologi Odenplan: collaborator
• Urologifocus Stockholm: collaborator

Related Publications (13)

• 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.

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• 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.

  PMID: 28498624 BACKGROUND

• 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.

  PMID: 30898406 BACKGROUND

• 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.

  PMID: 30082150 BACKGROUND

• 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.

  PMID: 31022301 BACKGROUND

• 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.

  PMID: 28110982 BACKGROUND

• 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.

  PMID: 29552975 BACKGROUND

• 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.

  PMID: 23787356 BACKGROUND

• Grummet J, Gorin MA, Popert R, O'Brien T, Lamb AD, Hadaschik B, Radtke JP, Wagenlehner F, Baco E, Moore CM, Emberton M, George AK, Davis JW, Szabo RJ, Buckley R, Loblaw A, Allaway M, Kastner C, Briers E, Royce PL, Frydenberg M, Murphy DG, Woo HH. "TREXIT 2020": why the time to abandon transrectal prostate biopsy starts now. Prostate Cancer Prostatic Dis. 2020 Mar;23(1):62-65. doi: 10.1038/s41391-020-0204-8. Epub 2020 Jan 13. No abstract available.

  PMID: 31932659 BACKGROUND

• Kum F, Elhage O, Maliyil J, Wong K, Faure Walker N, Kulkarni M, Namdarian B, Challacombe B, Cathcart P, Popert R. Initial outcomes of local anaesthetic freehand transperineal prostate biopsies in the outpatient setting. BJU Int. 2020 Feb;125(2):244-252. doi: 10.1111/bju.14620. Epub 2019 Dec 3.

  PMID: 30431694 BACKGROUND

• Kuru TH, Wadhwa K, Chang RT, Echeverria LM, Roethke M, Polson A, Rottenberg G, Koo B, Lawrence EM, Seidenader J, Gnanapragasam V, Axell R, Roth W, Warren A, Doble A, Muir G, Popert R, Schlemmer HP, Hadaschik BA, Kastner C. Definitions of terms, processes and a minimum dataset for transperineal prostate biopsies: a standardization approach of the Ginsburg Study Group for Enhanced Prostate Diagnostics. BJU Int. 2013 Sep;112(5):568-77. doi: 10.1111/bju.12132. Epub 2013 Jun 17.

  PMID: 23773772 BACKGROUND

• 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.

  PMID: 32999465 BACKGROUND

• Epstein JI, Egevad L, Amin MB, Delahunt B, Srigley JR, Humphrey PA; Grading Committee. The 2014 International Society of Urological Pathology (ISUP) Consensus Conference on Gleason Grading of Prostatic Carcinoma: Definition of Grading Patterns and Proposal for a New Grading System. Am J Surg Pathol. 2016 Feb;40(2):244-52. doi: 10.1097/PAS.0000000000000530.

  PMID: 26492179 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Tobias Nordström, PhD

  Karolinska Institutet

  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: MD PhD

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: April 1, 2023
• Primary Completion: November 1, 2025
• Study Completion: November 15, 2025
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share