Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
1 other identifier
interventional
1,676
2 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2013
Longer than P75 for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 3, 2014
CompletedFirst Posted
Study publicly available on registry
March 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedResults Posted
Study results publicly available
January 8, 2019
CompletedFebruary 26, 2019
February 1, 2019
3 years
March 3, 2014
November 5, 2018
February 6, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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).
Secondary Outcomes (2)
Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training
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.
Combined Sensitivity and Specificity in Determining Cancer Detection Overall for Image-guided Biopsy
First visit (a patient's involvement in the trial is complete following his biopsy).
Study Arms (2)
LR-TRUS
ACTIVE COMPARATORLow-resolution transrectal ultrasound guided prostate biopsy (standard of care)
UHR-TRUS
EXPERIMENTALUltra-high resolution transrectal ultrasound guided prostate biopsy
Interventions
Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
Ultrasound guided prostate biopsy using standard of care ultrasound system
Eligibility Criteria
You may qualify if:
- PSA\<50
- Clinical stage \< cT3
You may not qualify if:
- Men with a history of prostate cancer
- Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
- Men with known prostate volume (from prior imaging) of \> 60cc
- Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- Men who are unable to provide their own informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exact Imaginglead
Study Sites (5)
Johns Hopkins Brady Urological Institution
Baltimore, Maryland, 21224, United States
Urology of Virgina
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
Related Publications (1)
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.
PMID: 29627083DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Manager, Clinical Research
- Organization
- Exact Imaging
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2014
First Posted
March 5, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2016
Study Completion
February 1, 2018
Last Updated
February 26, 2019
Results First Posted
January 8, 2019
Record last verified: 2019-02