Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 79 |
| Updated: | 2/28/2019 |
| Start Date: | December 2013 |
| End Date: | February 2018 |
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.
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:
- 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.
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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3
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