OPTIMUM: Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

Sponsor

Sunnybrook Health Sciences Centre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05220501

Collaborator

Exact Imaging (Industry)

1,200

Enrollment

Locations

Arms

Anticipated Duration (Months)

600

Patients Per Site

17.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: Micro-US Targeted Biopsy Diagnostic Test: MRI Targeted Biopsy	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

1200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

All three arms will be active at the same time and subjects will be randomized to one arm.All three arms will be active at the same time and subjects will be randomized to one arm.

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

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.

Anticipated Study Start Date :

Feb 1, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Micro-US Only Subjects will undergo biopsy using micro-ultrasound only.	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.
Active Comparator: mpMRI + Micro-US Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound	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. Diagnostic Test: MRI Targeted Biopsy All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.
Active Comparator: mpMRI Only Subjects will undergo biopsy using mpMRI fused with regular ultrasound	Diagnostic Test: MRI Targeted Biopsy All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.

Arm

Intervention/Treatment

Active Comparator: Micro-US Only

Subjects will undergo biopsy using micro-ultrasound only.

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.

Active Comparator: mpMRI + Micro-US

Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound

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.

Diagnostic Test: MRI Targeted Biopsy

All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.

Active Comparator: mpMRI Only

Subjects will undergo biopsy using mpMRI fused with regular ultrasound

Diagnostic Test: MRI Targeted Biopsy

All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.

Outcome Measures

Primary Outcome Measures

Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques [Immediately after biopsy]
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.

Secondary Outcome Measures

Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy [Immediately after 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).

Other Outcome Measures

Prediction of biopsy outcome using imaging risk scores [Immediately after biopsy]
Difference in negative predictive value of highest risk score per patient for prediction of csPCa on biopsy
Added cases of csPCa detected by each biopsy technique [Immediately after biopsy]
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.
Cost of Interventions [7 days after biopsy]
Comparison of cost, in dollars, of interventions in each arm.
Procedure Time of Interventions [7 days after biopsy]
Comparison of procedure time, in minutes, of interventions in each arm.
Patient Satisfaction using a modified PROBE Questionnaire [7 days after biopsy]
Comparison of patient satisfaction using the "Perception" subset of questions from the PROBE Questionnaire of the ProTect study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ordensklinikum Elisabethinen	Linz		Austria
2	Sunnybrook and Women's College Health Sciences Centre	Toronto	Ontario	Canada	M4N3M5

Sponsors and Collaborators

Sunnybrook Health Sciences Centre
Exact Imaging

Investigators

Principal Investigator: Laurence Klotz, Sunnybrook Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Laurence Klotz, Affiliate Scientist, Sunnybrook Health Sciences Centre

ClinicalTrials.gov Identifier:

NCT05220501

Other Study ID Numbers:

EVU-2021-001

First Posted:

Feb 2, 2022

Last Update Posted:

Feb 2, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Dr. Laurence Klotz, Affiliate Scientist, Sunnybrook Health Sciences Centre

prostate

prostate biopsy

micro-ultrasound

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Feb 2, 2022