NCT03936127

Brief Summary

This study is designed as a randomized control trial which intends to determine if transperineal (TP) targeted biopsy is not inferior to transrectal (TR) targeted biopsy for diagnosis of clinically significant prostate cancer while comparing post-procedural infection rates between the two techniques. The study will also look to compare patient reported pain scores related to the procedure, rates of other minor complications (e.g. bleeding, urinary retention) and procedure time. The expected sample size at The Ottawa Hospital is 360 men.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
360

participants targeted

Target at P75+ for not_applicable prostate-cancer

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 3, 2019

Completed
3.4 years until next milestone

Study Start

First participant enrolled

October 11, 2022

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

October 25, 2022

Status Verified

October 1, 2022

Enrollment Period

2.1 years

First QC Date

April 25, 2019

Last Update Submit

October 21, 2022

Conditions

Prostate Cancer

Keywords

TransperinealTransrectalFusion Biopsy

Outcome Measures

Primary Outcomes (1)

  • Infection Rate

    Number of patients with or without post-procedural infection.

    Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.

Secondary Outcomes (1)

  • Clinically Significant Prostate Cancer

    Patients who have undergone biopsy of the prostate will be seen by their Urologist in routine clinical follow-up, typically in 4-6 weeks, as per standard of care.

Study Arms (2)

Transperineal (TP) Ultrasound (US) Targeted Fusion Biopsy

EXPERIMENTAL

Transperineal (TP) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).

Procedure: Ultrasound (US) Targeted Fusion Biopsy

Transrectal (TR) Ultrasound (US) Targeted Fusion Biopsies

ACTIVE COMPARATOR

Transrectal (TR) ultrasound (US) targeted fusion biopsy (which is performed using a validated Health Canada approved elastic software fusion platform).

Procedure: Ultrasound (US) Targeted Fusion Biopsy

Interventions

Ultrasound (US) Targeted Fusion BiopsyPROCEDURE

Ultrasound (US) Targeted Fusion Biopsy

Transperineal (TP) Ultrasound (US) Targeted Fusion BiopsyTransrectal (TR) Ultrasound (US) Targeted Fusion Biopsies

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility DetailsThe expected sample size at The Ottawa Hospital is 360 men.
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • MRI positive - abnormal area detected
  • Patient re-evaluated in the TOH Prostate CAC (Cancer Assessment Centre) for planning of targeted biopsy
  • Signed Consent

You may not qualify if:

  • MRI negative - no abnormal area detected
  • Patient with a prior diagnosis of prostate cancer enrolled in active surveillance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

Related Publications (13)

  • 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: 28110982BACKGROUND

  • 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: 29552975BACKGROUND

  • Nam RK, Saskin R, Lee Y, Liu Y, Law C, Klotz LH, Loblaw DA, Trachtenberg J, Stanimirovic A, Simor AE, Seth A, Urbach DR, Narod SA. Increasing hospital admission rates for urological complications after transrectal ultrasound guided prostate biopsy. J Urol. 2013 Jan;189(1 Suppl):S12-7; discussion S17-8. doi: 10.1016/j.juro.2012.11.015.

    PMID: 23234616BACKGROUND

  • Rudzinski JK, Kawakami J. Incidence of infectious complications following transrectal ultrasound-guided prostate biopsy in Calgary, Alberta, Canada: A retrospective population-based analysis. Can Urol Assoc J. 2014 May;8(5-6):E301-5. doi: 10.5489/cuaj.1751.

    PMID: 24940454BACKGROUND

  • Guo LH, Wu R, Xu HX, Xu JM, Wu J, Wang S, Bo XW, Liu BJ. Comparison between Ultrasound Guided Transperineal and Transrectal Prostate Biopsy: A Prospective, Randomized, and Controlled Trial. Sci Rep. 2015 Nov 3;5:16089. doi: 10.1038/srep16089.

    PMID: 26526558BACKGROUND

  • Verma S, Choyke PL, Eberhardt SC, Oto A, Tempany CM, Turkbey B, Rosenkrantz AB. The Current State of MR Imaging-targeted Biopsy Techniques for Detection of Prostate Cancer. Radiology. 2017 Nov;285(2):343-356. doi: 10.1148/radiol.2017161684.

    PMID: 29045233BACKGROUND

  • Barrett T, Haider MA. The Emerging Role of MRI in Prostate Cancer Active Surveillance and Ongoing Challenges. AJR Am J Roentgenol. 2017 Jan;208(1):131-139. doi: 10.2214/AJR.16.16355. Epub 2016 Oct 11.

    PMID: 27726415BACKGROUND

  • Kosarek CD, Mahmoud AM, Eyzaguirre EJ, Shan Y, Walser EM, Horn GL, Williams SB. Initial series of magnetic resonance imaging (MRI)-fusion targeted prostate biopsy using the first transperineal targeted platform available in the USA. BJU Int. 2018 Nov;122(5):909-912. doi: 10.1111/bju.14206. Epub 2018 Apr 14.

    PMID: 29569311BACKGROUND

  • Costa DN, Kay FU, Pedrosa I, Kolski L, Lotan Y, Roehrborn CG, Hornberger B, Xi Y, Francis F, Rofsky NM. An initial negative round of targeted biopsies in men with highly suspicious multiparametric magnetic resonance findings does not exclude clinically significant prostate cancer-Preliminary experience. Urol Oncol. 2017 Apr;35(4):149.e15-149.e21. doi: 10.1016/j.urolonc.2016.11.006. Epub 2016 Dec 9.

    PMID: 27939349BACKGROUND

  • Oderda M, Faletti R, Battisti G, Dalmasso E, Falcone M, Marra G, Palazzetti A, Zitella A, Bergamasco L, Gandini G, Gontero P. Prostate Cancer Detection Rate with Koelis Fusion Biopsies versus Cognitive Biopsies: A Comparative Study. Urol Int. 2016;97(2):230-7. doi: 10.1159/000445524. Epub 2016 Jun 4.

    PMID: 27256369BACKGROUND

  • Weinreb JC, Barentsz JO, Choyke PL, Cornud F, Haider MA, Macura KJ, Margolis D, Schnall MD, Shtern F, Tempany CM, Thoeny HC, Verma S. PI-RADS Prostate Imaging - Reporting and Data System: 2015, Version 2. Eur Urol. 2016 Jan;69(1):16-40. doi: 10.1016/j.eururo.2015.08.052. Epub 2015 Oct 1.

    PMID: 26427566BACKGROUND

  • Breivik H, Borchgrevink PC, Allen SM, Rosseland LA, Romundstad L, Hals EK, Kvarstein G, Stubhaug A. Assessment of pain. Br J Anaesth. 2008 Jul;101(1):17-24. doi: 10.1093/bja/aen103. Epub 2008 May 16.

    PMID: 18487245BACKGROUND

  • Schmit GD, Schenck LA, Thompson RH, Boorjian SA, Kurup AN, Weisbrod AJ, Kor DJ, Callstrom MR, Atwell TD, Carter RE. Predicting renal cryoablation complications: new risk score based on tumor size and location and patient history. Radiology. 2014 Sep;272(3):903-10. doi: 10.1148/radiol.14132548. Epub 2014 May 7.

    PMID: 24814178BACKGROUND

Related Links

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Nicola Schieda, MD

    The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicola Schieda, MD

CONTACT

613-759-0958nschieda@toh.ca

Betty Anne Schwarz, PhD

CONTACT

613-798-5555baschwarz@toh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Abdominal and Pelvic MRI, The Ottawa Hospital

Study Record Dates

First Submitted

April 25, 2019

First Posted

May 3, 2019

Study Start

October 11, 2022

Primary Completion

December 1, 2024

Study Completion

December 1, 2024

Last Updated

October 25, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

De-identified individual participant data for all primary and secondary outcome measures will be made available.

Time Frame
The Principal Investigator will aim to have data available within 12 months of study completion.
Access Criteria
* Authors aim to have the study presented at conferences and published in a peer-reviewed journal. * Authors aim to have the study presented at conferences and published in a peer-reviewed journal. * A description of this clinical trial/study will be available on http://www.clinicaltrials.gov. Participants can search this website at anytime to obtain all study information.
More information

Locations

CA(1)