Clinical trial NCT05220501: Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
Official title: Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI: a 3-arm Randomized Controlled Trial Evaluating the Role of 29MHz Micro-ultrasound in Guiding Prostate Biopsy in Men with Clinical Suspicion of Prostate Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: prostate
prostate biopsy
micro-ultrasound
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Exact Imaging
First posted: 2022-02-02
Enrollment: 804
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All three arms will be active at the same time and subjects will be randomized to one arm.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Men indicated for prostate biopsy due to elevated Prostate Specific Antigen and/or abnormal 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 months prior to screening and enrollment in the study

Exclusion Criteria:

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

Primary outcomes:
measure: Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques
timeFrame: Immediately after biopsy
Secondary outcomes:
measure: Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy
timeFrame: Immediately after biopsy
Other outcomes:
measure: Prediction of biopsy outcome using imaging risk scores
timeFrame: Immediately after biopsy
measure: Cost of Interventions
timeFrame: 7 days after biopsy
measure: Procedure Time of Interventions
timeFrame: 7 days after biopsy
measure: Number of Clinically Significant Prostate Cancer (csPCa) cases found exclusively by each biopsy strategy
timeFrame: Immediately after biopsy
measure: Patient Satisfaction using a modified Prostate Biopsy Effects (ProBE) Questionnaire
timeFrame: 7 days after biopsy
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Gainsville
country: United States
facility: University of Florida Health
state: Florida
city: Baltimore
country: United States
facility: Johns Hopkins
state: Maryland
city: Myrtle Beach
country: United States
facility: Carolina Urologic Research Center
state: South Carolina
city: Linz
country: Austria
facility: Ordensklinikum Elisabethinen
city: Brussels
country: Belgium
facility: Hopital Delta
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Princess Margaret Hospital
state: Ontario
city: Montréal
country: Canada
facility: Hôpital Maisonneuve-Rosemont
state: Quebec
city: Montréal
country: Canada
facility: Hôpital du Sacré-Cœur de Montréal
state: Quebec
city: Martigues
country: France
facility: Centre Hospitàlier Martigues, Hôpitaux de Provence
city: Paris
country: France
facility: L'Institut Mutualiste Montsouris
city: Magdeburg
country: Germany
facility: University of Magdeburg
state: Saxony-Anholt
city: Berlin
country: Germany
facility: ProUro
city: Brandenburg
country: Germany
facility: University of Brandenburg
city: Tuebingen
country: Germany
facility: University of Tuebingen
city: Milano
country: Italy
facility: Humanitas
city: Bilbao
country: Spain
facility: Urologica Clinica Bilbao
city: Madrid
country: Spain
facility: Madrid ROC
city: Madrid
country: Spain
facility: ICUA Madrid
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Laurence Klotz, MD
role: PRINCIPAL_INVESTIGATOR
References: