Prostate Cancer Clinical Trial

Optimization of Prostate Biopsy – Micro-Ultrasound Versus MRI

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Men indicated for prostate biopsy due to elevated PSA and/or abnormal DRE
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

Exclusion Criteria:

History of prior prostate biopsy
History of genitourinary cancer, including prostate cancer
Contraindications to biopsy
Contraindications to mpMRI

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1200

Study ID:

NCT05220501

Recruitment Status:

Recruiting

Sponsor:

Sunnybrook Health Sciences Centre

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There are 6 Locations for this study

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Yale University
New Haven Connecticut, 06511, United States More Info
Joseph Renzulli, MD
Contact
[email protected]
Joseph Brito, MD
Contact
[email protected]
University of Florida Health
Gainesville Florida, 32611, United States
John Hopkins
Baltimore Maryland, 21205, United States More Info
Christian Pavlovich, MD
Contact
[email protected]
Michael Rezaee, MD
Contact
[email protected]
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Neal Shore, MD
Contact
[email protected]
Robert Jansen, MD
Contact
[email protected]
Ordensklinikum Elisabethinen
Linz , , Austria More Info
Ferdinand Luger, MD
Contact
[email protected]
Hopital Delta
Brussels , , Belgium More Info
Mohammed Ouertani, MD
Contact
[email protected]
Eddie Cohen, MD
Contact
[email protected]
University of Alberta
Edmonton Alberta, T6G1Z, Canada More Info
Adam Kinnaird, MD
Contact
[email protected]
Stacey Broomfield, PhD
Contact
[email protected]
Sunnybrook and Women's College Health Sciences Centre
Toronto Ontario, M4N3M, Canada More Info
Marlene Kebabdjian
Contact
416-480-6100
[email protected]
Laurence Klotz, MD, FRCSC
Principal Investigator
L'Institut Mutualiste Montsouris
Paris , , France More Info
Petr Macek, MD
Contact
[email protected]
ProUro
Berlin , , Germany More Info
Hannes Cash, MD
Contact
[email protected]
Univerisy of Tuebingen
Tuebingen , , Germany More Info
Niklas Harland, MD
Contact
[email protected]
Urologica Clinica Bilbao
Bilbao , , Spain More Info
Felipe Urdaneta, MD
Contact
[email protected]
Txetxu Pereira, MD
Contact
[email protected]
ICUA Madrid
Madrid , , Spain More Info
Javier Reinoso, MD
Contact
[email protected]
Moises Socarras, MD
Contact
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Estimated Enrollment:

1200

Study ID:

NCT05220501

Recruitment Status:

Recruiting

Sponsor:


Sunnybrook Health Sciences Centre

How clear is this clinincal trial information?

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