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

Sunnybrook Health Sciences Centre

Status: Completed

Conditions: Prostate Cancer

Treatments: Diagnostic Test: MRI Targeted Biopsy; Diagnostic Test: Microultrasonography Targeted Biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05220501

EVU-2021-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 804 patients

Sex: Male

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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804 participants in 3 patient groups

Microultrasonography only

Active Comparator group

Description:

Subjects will undergo biopsy using micro-ultrasound only.

Treatment:

Diagnostic Test: Microultrasonography Targeted Biopsy

Microultrasonography + MRI

Active Comparator group

Description:

Subjects will undergo fusion biopsy using mpMRI and micro-ultrasound

Treatment:

Diagnostic Test: Microultrasonography Targeted Biopsy

Diagnostic Test: MRI Targeted Biopsy

MRI + Conventional Ultrasonography

Active Comparator group

Description:

Subjects will undergo biopsy using mpMRI fused with regular ultrasound

Treatment:

Diagnostic Test: MRI Targeted Biopsy