Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Prostate Cancer Clinical Trial

— OPTIMUM  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05220501
• Other study ID #: EVU-2021-001
• Status: Recruiting
• Phase: N/A
• Start date: January 21, 2021
• Est. completion date: March 2025

Study information

• Verified date: October 2023
• Source: Sunnybrook Health Sciences Centre
• Contact: Laurence Klotz, Dr
• Phone: 4164804673
• Email: laurence.klotz[@]sunnybrook.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: March 2025
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years and older

Eligibility

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
• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Diagnostic Test:
• Micro-US Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
• MRI Targeted Biopsy
All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.

Locations

Country	Name	City	State
Austria	Ordensklinikum Elisabethinen	Linz
Belgium	Hopital Delta	Brussels
Canada	University of Alberta	Edmonton	Alberta
Canada	Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario
Canada	University Health Network - Princess Margaret Hospital	Toronto	Ontario
France	L'Institut Mutualiste Montsouris	Paris
Germany	ProUro	Berlin
Germany	University of Brandenburg	Brandenburg
Germany	University of Magdeburg	Magdeburg	Saxony-Anholt
Germany	Univerisy of Tuebingen	Tuebingen
Spain	Urologica Clinica Bilbao	Bilbao
Spain	ICUA Madrid	Madrid
United States	John Hopkins	Baltimore	Maryland
United States	University of Florida Health	Gainesville	Florida
United States	UCLA	Los Angeles	California
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	Yale University	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre	Exact Imaging

Countries where clinical trial is conducted

United States,  Austria,  Belgium,  Canada,  France,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Prediction of biopsy outcome using imaging risk scores	Difference in negative predictive value of highest risk score per patient for prediction of csPCa on biopsy	Immediately after biopsy
Other	Added cases of csPCa detected by each biopsy technique	Added value (in additional cases of csPCa detected) of each biopsy technique (mpMRI Targeted, MicroUS Targeted, Systematic) when added to the others to optimize the biopsy protocol.	Immediately after biopsy
Other	Cost of Interventions	Comparison of cost, in dollars, of interventions in each arm.	7 days after biopsy
Other	Procedure Time of Interventions	Comparison of procedure time, in minutes, of interventions in each arm.	7 days after biopsy
Other	Patient Satisfaction using a modified PROBE Questionnaire	Comparison of patient satisfaction using the "Perception" subset of questions from the PROBE Questionnaire of the ProTect study.	7 days after biopsy
Primary	Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques	Difference in detection rate of Grade Group > 1 Prostate Cancer (csPCa) found during biopsy between the two biopsy interventions tested: mpMRI Biopsy and MicroUS Biopsy.	Immediately after biopsy
Secondary	Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy	Difference in detection rate of Grade Group > 1 Prostate Cancer (csPCa) found during biopsy between the two fusion biopsy techniques used: conventional mpMRI/US Biopsy (mpMRI+US arm) and mpMRI/MicroUS Biopsy (mpMRI + Micro-US arm).	Immediately after biopsy