Prostatic NeoplasmsNCT02079025
Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
A study testing High-resolution ultrasound guided prostate biopsy and Standard ultrasound guided prostate biopsy in people with Prostatic Neoplasms and Prostate Cancer, run by Exact Imaging at 5 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 79 years, men only
- Conditions the study is for
- Prostatic Neoplasms, Prostate Cancer, Cancer of the Prostate
- What is being tested?
- High-resolution ultrasound guided prostate biopsy and Standard ultrasound guided prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,676 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2013to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Canada3 sites
Prostate Cancer Centre
Calgary, Alberta, T2V 1P9
Centre de Recherche sur le Cancer ("CRCEO")
Québec, Quebec, G1R 2J6
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9
United States2 sites
Johns Hopkins Brady Urological Institution
Baltimore, Maryland, 21224
Urology of Virgina
Virginia Beach, Virginia, 23452
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Prostatic Neoplasms, Prostate Cancer, Cancer of the Prostate
- Being tested
- High-resolution ultrasound guided prostate biopsy, Standard ultrasound guided prostate biopsy
- Keywords
- Prostate Biopsy, Ultrasound guided biopsy of the prostate, High-resolution ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-resolution ultrasound guided prostate biopsyDevice
Also called ImagistxProstate Urology Ultrasound System
Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
Standard ultrasound guided prostate biopsyDevice
Ultrasound guided prostate biopsy using standard of care ultrasound system
| Study group | Role | What they receive |
|---|---|---|
| LR-TRUS | Active comparator | Low-resolution transrectal ultrasound guided prostate biopsy (standard of care) Receives: Device: Standard ultrasound guided prostate biopsy |
| UHR-TRUS | Experimental | Ultra-high resolution transrectal ultrasound guided prostate biopsy Receives: Device: High-resolution ultrasound guided prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Comparison of pre- and post-training percentage of participants found to harbor clinically significant prostate cancer within the UHR-TRUS arm of the trial
Measured: 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
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.
Measured: First visit (a patient's involvement in the trial is complete following his biopsy).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,676 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079025
- Sponsor's protocol ID
- 2013-UHR-002
- Status last verified
- Feb 2019
- First submitted
- 3 Mar 2014
- Last updated
- 26 Feb 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 29627083
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-Center Trial of High-resolution Transrectal Ultrasound Versus Standard Low-resolution Transrectal Ultrasound for the Identification of Clinically Significant Prostate Cancer
- ClinicalTrials.gov ID
- NCT02079025
- Acronym / sponsor ID
- 2013-UHR-002
- Conditions
- Prostatic Neoplasms, Prostate Cancer, Cancer of the Prostate
- Keywords
- Prostate Biopsy, Ultrasound guided biopsy of the prostate, High-resolution ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,676 participants (actual)
- Lead sponsor
- Exact ImagingIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 5 Mar 2014 (estimated)
- Results
- Posted 8 Jan 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LR-TRUS | Active comparator | Device: Standard ultrasound guided prostate biopsyLow-resolution transrectal ultrasound guided prostate biopsy (standard of care) |
| UHR-TRUS | Experimental | Device: High-resolution ultrasound guided prostate biopsyUltra-high resolution transrectal ultrasound guided prostate biopsy |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-resolution ultrasound guided prostate biopsyAlso: ImagistxProstate Urology Ultrasound SystemUltrasound guided prostate biopsy using ultra-high resolution ultrasound system | Device | UHR-TRUS |
| Standard ultrasound guided prostate biopsyUltrasound guided prostate biopsy using standard of care ultrasound system | Device | LR-TRUS |
Primary outcome
Percentage of Participants With Clinically Significant Prostate Cancer
Time frame: First visit (a patient's involvement in the trial is complete following his biopsy).
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.
2 secondary outcomes
Improvement of an Investigator's Ability to Detect Clinically Significant Cancer Using UHR-TRUS Post-training When Compared to Pre-training
Time frame: 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
Time frame: First visit (a patient's involvement in the trial is complete following his biopsy).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29627083Rohrbach 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-resolution ultrasound guided prostate biopsy and Standard ultrasound guided prostate biopsy in people with Prostatic Neoplasms and Prostate Cancer, run by Exact Imaging at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Clinically Significant Prostate Cancer (time frame: First visit (a patient's involvement in the trial is complete following his biopsy).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02079025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2019.