Cancer, Prostate Cancer

Not Applicable

Interventional Study

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

Sponsor

Sunnybrook Health Sciences Centre

Start Date

21/01/2021

Completion Date

31/03/2024

Sex

MEN

Enrollment

1200

Ages From

18

Healthy Volunteers?

Yes

Contact

Laurence Klotz, Dr

Location

University of Alberta

Trial Details

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.

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.

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.

Selection Criteria

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

Eligibility Exclusion Criteria

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

ARMS & Interventions

PARTICIPANT GROUP ARMINTERVENTION 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-ultrasoundDiagnostic 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 ultrasoundDiagnostic Test: MRI Targeted Biopsy - All subjects will be biopsied no matter their arm randomization. In this group, MRI targets will be identified and sampled.

Primary Outcome

MeasuresMeasure DescriptionMEASURE TIME FRAME
Difference in csPCa rate between mpMRI-based and MicroUS-based biopsy techniquesDifference 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 Outcome

MEASURESMEASURE DESCRIPTIONMEASURE TIME FRAME
Difference in csPCa rate between conventional mpMRI/US fusion biopsy and mpMRI/MicroUS fusion biopsyDifference 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

Other Outcome

MEASURESMEASURE DESCRIPTIONMEASURE TIME FRAME
Prediction of biopsy outcome using imaging risk scoresDifference in negative predictive value of highest risk score per patient for prediction of csPCa on biopsyImmediately after biopsy
Added cases of csPCa detected by each biopsy techniqueAdded 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
Cost of InterventionsComparison of cost, in dollars, of interventions in each arm.7 days after biopsy
Procedure Time of InterventionsComparison of procedure time, in minutes, of interventions in each arm.7 days after biopsy
Patient Satisfaction using a modified PROBE QuestionnaireComparison of patient satisfaction using the "Perception" subset of questions from the PROBE Questionnaire of the ProTect study.7 days after biopsy

Send Email

We are sending an email to the trial authority, are you sure?
Yes
No