Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
Completed · Not applicable
Conditions studied: Prostatic Neoplasms, Prostate Cancer, Cancer of the Prostate
In brief
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.
Key facts
- Study ID
- NCT02079025
- Run by
- Exact Imaging
- People needed
- 1676
- Starts
- 2013-12-01
- Expected to finish
- 2018-02-01
- Last updated by the study team
- 2019-02-26
Who can join
Age: 40 and older, up to 79. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- All men > 40 years age and <80 years of age with an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam).
- 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
Where it is running
- Johns Hopkins Brady Urological Institution — Baltimore, Maryland, United States
- Urology of Virgina — Virginia Beach, Virginia, United States
- Prostate Cancer Centre — Calgary, Alberta, Canada
- Princess Margaret Cancer Centre — Toronto, Ontario, Canada
- Centre de Recherche sur le Cancer ("CRCEO") — Québec, Quebec, Canada
Full record on ClinicalTrials.gov
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