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Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI (OPTIMUM)

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Micro-US Targeted Biopsy
MRI Targeted Biopsy
Sponsored by
Sunnybrook Health Sciences Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer focused on measuring prostate, prostate biopsy, micro-ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Yale UniversityRecruiting
  • University of Florida Health
  • John HopkinsRecruiting
  • Carolina Urologic Research CenterRecruiting
  • Ordensklinikum ElisabethinenRecruiting
  • Hopital DeltaRecruiting
  • University of AlbertaRecruiting
  • Sunnybrook and Women's College Health Sciences CentreRecruiting
  • L'Institut Mutualiste MontsourisRecruiting
  • ProUroRecruiting
  • Univerisy of TuebingenRecruiting
  • Urologica Clinica BilbaoRecruiting
  • ICUA MadridRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Micro-US Only

mpMRI + Micro-US

mpMRI Only

Arm Description

Subjects will undergo biopsy using micro-ultrasound only.

Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound

Subjects will undergo biopsy using mpMRI fused with regular ultrasound

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
December 9, 2021
Last Updated
April 26, 2023
Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Exact Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT05220501
Brief Title
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sunnybrook Health Sciences Centre
Collaborators
Exact Imaging

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate, prostate biopsy, micro-ultrasound

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All three arms will be active at the same time and subjects will be randomized to one arm.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Micro-US Only
Arm Type
Active Comparator
Arm Description
Subjects will undergo biopsy using micro-ultrasound only.
Arm Title
mpMRI + Micro-US
Arm Type
Active Comparator
Arm Description
Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound
Arm Title
mpMRI Only
Arm Type
Active Comparator
Arm Description
Subjects will undergo biopsy using mpMRI fused with regular ultrasound
Intervention Type
Diagnostic Test
Intervention Name(s)
Micro-US Targeted Biopsy
Intervention Description
All subjects will be biopsied no matter their arm randomization. In this group, MicroUS targets will be identified and sampled.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI Targeted Biopsy
Intervention Description
All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.
Primary Outcome Measure Information:
Title
Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniques
Description
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.
Time Frame
Immediately after biopsy
Secondary Outcome Measure Information:
Title
Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsy
Description
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).
Time Frame
Immediately after biopsy
Other Pre-specified Outcome Measures:
Title
Prediction of biopsy outcome using imaging risk scores
Description
Difference in negative predictive value of highest risk score per patient for prediction of csPCa on biopsy
Time Frame
Immediately after biopsy
Title
Added cases of csPCa detected by each biopsy technique
Description
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.
Time Frame
Immediately after biopsy
Title
Cost of Interventions
Description
Comparison of cost, in dollars, of interventions in each arm.
Time Frame
7 days after biopsy
Title
Procedure Time of Interventions
Description
Comparison of procedure time, in minutes, of interventions in each arm.
Time Frame
7 days after biopsy
Title
Patient Satisfaction using a modified PROBE Questionnaire
Description
Comparison of patient satisfaction using the "Perception" subset of questions from the PROBE Questionnaire of the ProTect study.
Time Frame
7 days after biopsy

10. Eligibility

Sex
Male
Gender Based
Yes
Gender Eligibility Description
Participants need to have a prostate and have been referred to a urologist
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Klotz, Dr
Phone
4164804673
Email
laurence.klotz@sunnybrook.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Klotz
Organizational Affiliation
Sunnybrook Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Renzulli, MD
Email
joseph.renzulli@yale.edu
First Name & Middle Initial & Last Name & Degree
Joseph Brito, MD
Email
joseph.brito@yale.edu
Facility Name
University of Florida Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
John Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Pavlovich, MD
Email
cpavlov2@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Michael Rezaee, MD
Email
mrezaee2@jhmi.edu
Facility Name
Carolina Urologic Research Center
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neal Shore, MD
Email
nshore@gsuro.com
First Name & Middle Initial & Last Name & Degree
Robert Jansen, MD
Email
rjansen@atlanticurologyclinics.com
Facility Name
Ordensklinikum Elisabethinen
City
Linz
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ferdinand Luger, MD
Email
ferdinand.luger@ordensklinikum.at
Facility Name
Hopital Delta
City
Brussels
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Ouertani, MD
Email
mohammedsalah.ouertani@chirec.be
First Name & Middle Initial & Last Name & Degree
Eddie Cohen, MD
Email
eddiecohen@skynet.be
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G1Z1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adam Kinnaird, MD
Email
ask@ualberta.ca
First Name & Middle Initial & Last Name & Degree
Stacey Broomfield, PhD
Email
sbroomfi@ualberta.ca
Facility Name
Sunnybrook and Women's College Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marlene Kebabdjian
Phone
416-480-6100
Ext
2890
Email
marlene.kebabdjian@sunnybrook.ca
First Name & Middle Initial & Last Name & Degree
Laurence Klotz, MD, FRCSC
Facility Name
L'Institut Mutualiste Montsouris
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petr Macek, MD
Email
petr.macek@imm.fr
Facility Name
ProUro
City
Berlin
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hannes Cash, MD
Email
hannes.cash@prouro.de
Facility Name
Univerisy of Tuebingen
City
Tuebingen
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Niklas Harland, MD
Email
niklas.harland@med.uni-tuebingen.de
Facility Name
Urologica Clinica Bilbao
City
Bilbao
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felipe Urdaneta, MD
Email
luisurdaneta03@yahoo.es
First Name & Middle Initial & Last Name & Degree
Txetxu Pereira, MD
Email
txeper@yahoo.es
Facility Name
ICUA Madrid
City
Madrid
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Javier Reinoso, MD
Email
javier.reinoso@gmail.com
First Name & Middle Initial & Last Name & Degree
Moises Socarras, MD
Email
moisessocarras@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

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