Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Last updated: November 18, 2024
Sponsor: Sunnybrook Health Sciences Centre
Overall Status: Completed

Phase

N/A

Condition

Prostate Cancer

Urologic Cancer

Prostate Cancer, Early, Recurrent

Treatment

Micro-US Targeted Biopsy

MRI Targeted Biopsy

Clinical Study ID

NCT05220501
EVU-2021-001
  • Ages > 18
  • Male
  • Accepts Healthy Volunteers

Study Summary

OPTIMUM is a study designed to compare the ability of ultra-high resolution transrectal micro-ultrasound (microUS) and multiparametric MRI (mpMRI)/US fusion to guide prostate biopsy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/orabnormal Digital Rectal Examination

  • No history of prior prostate biopsy

  • No history of genitourinary cancer, including prostate cancer

  • 18 years or older

  • No contraindications to biopsy

  • No contraindications to mpMRI

  • No history of mpMRI for clinical investigation of prostate cancer within 12 monthsprior to screening and enrollment in the study

Exclusion

Exclusion Criteria:

  • History of prior prostate biopsy

  • History of genitourinary cancer, including prostate cancer

  • Contraindications to biopsy

  • Contraindications to mpMRI

Study Design

Total Participants: 804
Treatment Group(s): 2
Primary Treatment: Micro-US Targeted Biopsy
Phase:
Study Start date:
December 15, 2021
Estimated Completion Date:
November 06, 2024

Study Description

The purpose of the Clinical Investigation Plan and Study Protocol is to present information for the OPTIMUM clinical investigation, including the scientific basis for the study, the procedural details, the ExactVu High Resolution Micro-Ultrasound System, its safety details, and administrative details. It has been designed in such a way as to optimize the scientific validity and reproducibility of the results of the study in accordance with current clinical knowledge and practice so as to fulfill the objectives of the investigation.

Connect with a study center

  • Ordensklinikum Elisabethinen

    Linz,
    Austria

    Site Not Available

  • Hopital Delta

    Brussels,
    Belgium

    Site Not Available

  • University of Alberta

    Edmonton, Alberta T6G1Z1
    Canada

    Site Not Available

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N3M5
    Canada

    Site Not Available

  • Sunnybrook and Women's College Health Sciences Centre

    Toronto, Ontario M4N3M5
    Canada

    Active - Recruiting

  • University Health Network - Princess Margaret Hospital

    Toronto, Ontario M5G 2C4
    Canada

    Site Not Available

  • Hôpital Maisonneuve-Rosemont

    Montréal, Quebec H1T 2M4
    Canada

    Site Not Available

  • Hôpital du Sacré-Cœur de Montréal

    Montréal, Quebec H4J 1C5
    Canada

    Site Not Available

  • Centre Hospitàlier Martigues, Hôpitaux de Provence

    Martigues,
    France

    Site Not Available

  • L'Institut Mutualiste Montsouris

    Paris,
    France

    Site Not Available

  • University of Magdeburg

    Magdeburg, Saxony-Anholt 39120
    Germany

    Site Not Available

  • ProUro

    Berlin,
    Germany

    Site Not Available

  • University of Brandenburg

    Brandenburg,
    Germany

    Site Not Available

  • Univerisy of Tuebingen

    Tuebingen,
    Germany

    Active - Recruiting

  • University of Tuebingen

    Tuebingen,
    Germany

    Site Not Available

  • Humanitas

    Milano,
    Italy

    Site Not Available

  • Urologica Clinica Bilbao

    Bilbao,
    Spain

    Site Not Available

  • ICUA Madrid

    Madrid,
    Spain

    Site Not Available

  • Madrid ROC

    Madrid, 28010
    Spain

    Site Not Available

  • UCLA

    Los Angeles, California 90095
    United States

    Site Not Available

  • Yale University

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • University of Florida Health

    Gainesville, Florida 32611
    United States

    Site Not Available

  • University of Florida Health

    Gainsville, Florida 32611
    United States

    Site Not Available

  • John Hopkins

    Baltimore, Maryland 21205
    United States

    Active - Recruiting

  • Johns Hopkins

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina 29572
    United States

    Site Not Available

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