Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
Condition: Prostatic Neoplasms; Prostate Cancer; Cancer of the Prostate
MeSH terms: Prostatic Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      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:

        -  obtaining informed consent for the subject

        -  collecting pre-biopsy information and recording it on the case report form (CRF)

        -  perform biopsy procedure

        -  record biopsy details in CRF

        -  prepare biopsy specimens for pathology

      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.
    

Intervention name(s): High-resolution ultrasound guided prostate biopsy; Standard ultrasound guided prostate biopsy
Intervention type(s): Device; Device
Intervention description(s): Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system; Ultrasound guided prostate biopsy using standard of care ultrasound system
Other intervention name(s): ImagistxProstate Urology Ultrasound System
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Prostate Biopsy; Ultrasound guided biopsy of the prostate; High-resolution ultrasound