Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

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

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

Micro-US Targeted Biopsy

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

MRI Targeted Biopsy

Laurence Klotz, Dr

Wayne Brisbane, M.D.

Joseph Renzulli, MD

Joseph Brito, MD

Christian Pavlovich, MD

Michael Rezaee, MD

Neal Shore, MD

Robert Jansen, MD

Ferdinand Luger, MD

Adam Kinnaird, MD

Stacey Broomfield, PhD

Marlene Kebabdjian

Laurence Klotz, MD, FRCSC

Sangeet Ghai, M.D.

Kateri Corr

Petr Macek, MD

Martin Schostak, M.D.

Hannes Cash, MD

Julian Struck, M.D.

Niklas Harland, MD

Felipe Urdaneta, MD

Txetxu Pereira, MD

Javier Reinoso, MD

Moises Socarras, MD

Laurence Klotz

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.

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.

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

Participants need to have a prostate and have been referred to a urologist

Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI

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.

Difference in negative predictive value of highest risk score per patient for prediction of csPCa on 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.

Comparison of cost, in dollars, of interventions in each arm.

Comparison of procedure time, in minutes, of interventions in each arm.

Comparison of patient satisfaction using the "Perception" subset of questions from the PROBE Questionnaire of the ProTect study.

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.

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).

Exact Imaging

Sunnybrook Health Sciences Centre

Affiliate Scientist

Men in Arm A will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI. The unbiopsied men will have a repeat MRI at 2 years.

Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).

Standard of Care

Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.

Laurence Dr Klotz, MD

Antonio Hurtado-Coll

Peter Black, MD

Stephanie Horst

Joseph Chin, MD

Laurence Klotz, MD

Michael Nesbitt

Antonio Finelli, MD

Oleg Loutochin

Franck Bladou, MD

The aim of this study is to assess the efficacy of MRI-targeted biopsy compared to standard of care systematic TRUS guided biopsy in the detection of clinically significant and clinically insignificant prostate cancer in men without prior biopsy. The implication of this trial is that MRI-targeted biopsy could replace systematic TRUS guided biopsy as the standard of care in the diagnosis of prostate cancer.

The standard pathway for prostate cancer diagnosis is trans-rectal ultrasound guided (TRUS) biopsy of the prostate following an elevated PSA. TRUS guidance is performed primarily for anatomic guidance as the ultrasound poorly discriminates between cancerous and non-cancerous tissue. TRUS guided prostate biopsies are concentrated in areas of the peripheral zone, thought to harbor the majority of cancer.

An alternative pathway for prostate cancer diagnosis in men with elevated PSA is to perform multi-parametric magnetic resonance imaging (MPMRI) to localize cancer. This information is used to direct a subsequent biopsy, known as an MRI-targeted biopsy. MRI-targeted biopsy has been shown in preliminary studies to detect a similar or greater amount of clinically significant cancer than systematic TRUS guided biopsy and has several other potential advantages including: the ability to differentiate between clinically significant and insignificant cancer, reducing unnecessary biopsy and fewer numbers of biopsy cores, reducing biopsy-related side-effects.

A 'clinically insignificant cancer' is cancer that is unlikely to progress or to affect an individual's life expectancy and therefore does not warrant treatment. However when diagnosed with low grade cancer that is likely to be insignificant, a large proportion of subjects request treatment in case a more significant cancer is present. A challenge in this area is that subjects are typically not aware that their cancer is clinically insignificant, and often view the early diagnosis and aggressive treatment they have been subjected to as life-saving.

A prostate cancer detection procedure that differentiates clinically significant cancer from clinically insignificant cancer is therefore a major unmet need.

The potential implications of this trial include:

* A redefinition of the prostate cancer diagnostic pathway;
* A reduction in the number of subjects undergoing prostate biopsy;
* A reduction in the number of biopsy cores taken per subject;
* A reduction in biopsy-related adverse events including sepsis and pain;
* A reduction in the over-diagnosis of clinically insignificant prostate cancer;
* A reduction in the economic burden of diagnosing and treating prostate cancer.

PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures

A Phase III Multi-centre Open-label Randomized Controlled Trial of Multi-parametric Magnetic Resonance Imaging (MRI)-Targeted Biopsy Compared to Systematic Trans-rectal Ultrasound (TRUS) Guided Biopsy

To determine whether the proportion of men with clinically significant cancer (Gleason \> 7) detected by MRI-targeted biopsy is no less than systematic TRUS guided biopsy.

1. The proportion of men with clinically significant cancer (Gleason ≥7) detected by MRI-targeted biopsy is greater than systematic TRUS guided biopsy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI	NCT05220501	Prostate Cancer	Micro-US Target... MRI Targeted Bi...	18 Years -	Sunnybrook Health Sciences Centre
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI	NCT05220501	Prostate Cancer	Micro-US Target... MRI Targeted Bi...	18 Years -	Sunnybrook Health Sciences Centre
Optimization of Prostate Biopsy - Micro-Ultrasound Versus MRI	NCT05220501	Prostate Cancer	Micro-US Target... MRI Targeted Bi...	18 Years -	Sunnybrook Health Sciences Centre
PRostate Evaluation for Clinically Important Disease: MRI vs Standard Evaluation Procedures	NCT02936258	Prostate Cancer	Standard of Car... MRI MRI Targeted Bi...	18 Years -	Canadian Urology Research Consortium

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