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This trial uses a ultra high-resolution ultrasound system and specialized transducer, intended for use in prostate imaging. The system's image resolution is significantly better than the standard of care, due to its higher frequency. This allows the system to visualize suspicious areas and structures, and for greater accuracy for guided biopsy.
The primary objective of this study is to demonstrate that ultra high-resolution transrectal ultrasound (UHR-TRUS) is superior to conventional low-resolution transrectal ultrasound (LR-TRUS) in detecting clinically significant cancer among men without known prostate cancer and with an indication for prostate biopsy.
The secondary objective of this study is to compare the difference in the rate of detection of clinically significant cancer between LR-TRUS and UHR-TRUS, from before investigator training to after investigator training.
The tertiary objective for the investigation is to compare the combined sensitivity and specificity in determining cancer detection overall for image-guided biopsy in UHR-TRUS vs. LR-TRUS.
This is a two-arm multi-centre randomized trial of LR-TRUS versus UHR-TRUS for guided prostate biopsies in men with no known history of prostate cancer. This trial will enroll a minimum of 800 and a maximum of 2000 patients with regular interim analyses to determine the trial's final sample size. These numbers are based on predictive probabilities of trial success.
The investigation is designed as a comparative non-blinded analysis of LR-TRUS vs. UHR-TRUS. Participants will be randomized to either high-resolution or low resolution ultrasound with an equal chance of being in either group. The randomization scheme will be stratified by centre.
When a subject arrives at the institution for his biopsy, the Study Coordinator opens a sealed envelope that indicates to the study participant and physician whether the procedure will be performed using LR-TRUS or UHR-TRUS.
All subjects have an indication for prostate biopsy, and thus, inclusion of a non-treatment group would necessitate a group of men not to receive standard of care. As such, there is no control group in the subject population.
Procedures in the study are:
Data from CRFs will be stored in a proprietary database that is accessed by a web-based interface, where access is limited to those with login and password. No subject-identifiable information will be entered in the database.
The primary endpoint is the detection of clinically significant prostate cancer, i.e., the number of men with clinically significant prostate cancer determined by pathology review among all men randomized and biopsied. Pathological analysis on 12-core biopsy samples will be the only mechanism used to determine if study subjects have prostate cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LR-TRUS | Active Comparator | Low-resolution transrectal ultrasound guided prostate biopsy (standard of care) |
|
| UHR-TRUS | Experimental | Ultra-high resolution transrectal ultrasound guided prostate biopsy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-resolution ultrasound guided prostate biopsy | Device | Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Clinically Significant Prostate Cancer | Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients. | First visit (a patient's involvement in the trial is complete following his biopsy). |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training | Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial | Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Brady Urological Institution | Baltimore | Maryland | 21224 | United States | ||
| Urology of Virgina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29627083 | Derived | Rohrbach D, Wodlinger B, Wen J, Mamou J, Feleppa E. High-Frequency Quantitative Ultrasound for Imaging Prostate Cancer Using a Novel Micro-Ultrasound Scanner. Ultrasound Med Biol. 2018 Jul;44(7):1341-1354. doi: 10.1016/j.ultrasmedbio.2018.02.014. Epub 2018 Apr 4. |
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| ID | Title | Description |
|---|---|---|
| FG000 | LR-TRUS | Low-resolution transrectal ultrasound guided prostate biopsy (standard of care) Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system |
| FG001 | UHR-TRUS |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Standard ultrasound guided prostate biopsy | Device | Ultrasound guided prostate biopsy using standard of care ultrasound system |
|
| Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | Pathology analysis of prostate biopsy is reviewed. Sensitivity of targeted biopsy for each arm will be calculated as the number of targeted biopsy that also found cancer among all targeted biopsies. Specificity of targeted biopsy for each arm will be calculated as the number of non-targeted biopsies that find no cancer among all non-targeted biopsies. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients. | First visit (a patient's involvement in the trial is complete following his biopsy). |
| Virginia Beach |
| Virginia |
| 23452 |
| United States |
| Prostate Cancer Centre | Calgary | Alberta | T2V 1P9 | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Centre de Recherche sur le Cancer ("CRCEO") | Québec | Quebec | G1R 2J6 | Canada |
Ultra-high resolution transrectal ultrasound guided prostate biopsy
High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | LR-TRUS | Low-resolution transrectal ultrasound guided prostate biopsy (standard of care) Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system |
| BG001 | UHR-TRUS | Ultra-high resolution transrectal ultrasound guided prostate biopsy High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With Clinically Significant Prostate Cancer | Pathology analysis of prostate biopsy is reviewed for indication of clinically significant prostate cancer. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients. | Intent To Treat includes all subjects, Per Protocol includes only subjects without protocol deviations. | Posted | Number | percentage of participants with csPCa | First visit (a patient's involvement in the trial is complete following his biopsy). |
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| Secondary | Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training | Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial | Pre and post-training detection rate for csPCa for the UHR-TRUS arm only (as investigators received additional training on this imaging modality) | Posted | Number | Percentage of subjects with csPCa | Pre-training refers to all biopsy procedures occurring between initial training and mid-trial PRI-MUS training. Post-training refers to all biopsy procedures performed after mid-trial PRI-MUS training. |
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| ||||||||||||||||||||||||||||||
| Secondary | Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy | Pathology analysis of prostate biopsy is reviewed. Sensitivity of targeted biopsy for each arm will be calculated as the number of targeted biopsy that also found cancer among all targeted biopsies. Specificity of targeted biopsy for each arm will be calculated as the number of non-targeted biopsies that find no cancer among all non-targeted biopsies. Interim analyses are planned beginning when 800 patients have been enrolled and after every additional 200 patients are enrolled up to the maximum sample size of 2000 patients. | Posted | Number | percentage of post-training samples | First visit (a patient's involvement in the trial is complete following his biopsy). | Post-training biopsy samples | Post-training biopsy samples |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LR-TRUS | Low-resolution transrectal ultrasound guided prostate biopsy (standard of care) Standard ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using standard of care ultrasound system | 3 | 839 | 0 | 839 | ||
| EG001 | UHR-TRUS | Ultra-high resolution transrectal ultrasound guided prostate biopsy High-resolution ultrasound guided prostate biopsy: Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system | 3 | 837 | 0 | 837 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| post-biopsy bacteremia | Infections and infestations | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manager, Clinical Research | Exact Imaging | 905-415-0030 | 204 | bwodlinger@exactimaging.com |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| Per Protocol |
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| Units |
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| Post-training biopsy samples |
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