Prostate Cancer Clinical Trial
— OPTIMUMOfficial 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.
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.
Status | Recruiting |
Enrollment | 1200 |
Est. completion date | March 2025 |
Est. primary completion date | March 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
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 Exclusion Criteria: - History of prior prostate biopsy - History of genitourinary cancer, including prostate cancer - Contraindications to biopsy - Contraindications to mpMRI |
Country | Name | City | State |
---|---|---|---|
Austria | Ordensklinikum Elisabethinen | Linz | |
Belgium | Hopital Delta | Brussels | |
Canada | University of Alberta | Edmonton | Alberta |
Canada | Sunnybrook and Women's College Health Sciences Centre | Toronto | Ontario |
Canada | University Health Network - Princess Margaret Hospital | Toronto | Ontario |
France | L'Institut Mutualiste Montsouris | Paris | |
Germany | ProUro | Berlin | |
Germany | University of Brandenburg | Brandenburg | |
Germany | University of Magdeburg | Magdeburg | Saxony-Anholt |
Germany | Univerisy of Tuebingen | Tuebingen | |
Spain | Urologica Clinica Bilbao | Bilbao | |
Spain | ICUA Madrid | Madrid | |
United States | John Hopkins | Baltimore | Maryland |
United States | University of Florida Health | Gainesville | Florida |
United States | UCLA | Los Angeles | California |
United States | Carolina Urologic Research Center | Myrtle Beach | South Carolina |
United States | Yale University | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Sunnybrook Health Sciences Centre | Exact Imaging |
United States, Austria, Belgium, Canada, France, Germany, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Prediction of biopsy outcome using imaging risk scores | Difference in negative predictive value of highest risk score per patient for prediction of csPCa on biopsy | Immediately after biopsy | |
Other | Added cases of csPCa detected by each biopsy technique | 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. | Immediately after biopsy | |
Other | Cost of Interventions | Comparison of cost, in dollars, of interventions in each arm. | 7 days after biopsy | |
Other | Procedure Time of Interventions | Comparison of procedure time, in minutes, of interventions in each arm. | 7 days after biopsy | |
Other | Patient Satisfaction using a modified PROBE Questionnaire | Comparison of patient satisfaction using the "Perception" subset of questions from the PROBE Questionnaire of the ProTect study. | 7 days after biopsy | |
Primary | 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. | Immediately after biopsy | |
Secondary | 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). | Immediately after biopsy |
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