Prostate CancerNCT04175730
Prostate Cancer Detection Screening MRI Protocol
A study testing Ultrasound and MRI and Ultrasound in people with Prostate Cancer, run by University of Illinois at Chicago at 1 site in United States.
Trial summary
Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ultrasound and MRI and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2019to 14 Dec 2020
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult men between 18 and 80 years of age
- Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician
- Ability to provide informed consent
Who cannot join
- Prior prostate biopsy
- Prior diagnosis of PCa
- MRI incompatible implanted medical devices or foreign bodies
- Rectal anatomy incompatible with TRUS biopsy
- Life expectancy <10 years as determined by the treating urologist
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Chicago Hospital and Ambulatory Clinics
Chicago, Illinois, 60612
About this study
Official title: Prostate Cancer Detection Using a Quantitative Screening MRI Protocol
Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.
Read the detailed description
This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology clinics. All eligible men will be screened and enrolled by the clinical research coordinator. Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC) prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation in pathology. Biopsy results will be communicated to the patients by the Urologist performing the biopsy and all additional management will be SOC. This visit will signify the end of the study
- Conditions
- Prostate Cancer
- Being tested
- Ultrasound and MRI, 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.
Ultrasound and MRIDevice
A single subsequent ultrasound guided prostate biopsy with MRI fusion
UltrasoundDevice
A single subsequent ultrasound guided prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| MRI and Ultrasound | Other | men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies Receives: Device: Ultrasound and MRI |
| Ultrasound | Other | men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies Receives: Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology
Per subject prevalence of any grade or high grade (Gleason score 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Measured: 19 months
Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology
Per biopsy sample prevalence of high grade (Gleason 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Measured: 19 months
Number of Participants With PI-RADS 4-5 on MRI
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Measured: 19 months
Number of Participants With PI-RADS <4 MRI
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Measured: 19 months
Number of Participants That Had Adverse Events
Adverse events of prostate biopsy using the Clavien-Dindo scale
Measured: 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start20 May 2019
- Primary completion14 Dec 2020
- Study completion14 Dec 2020
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.
- Other trials for Prostate CancerStudies 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 50 men with clinical suspicion of PCa (elevated Prostate specific antigen (PSA) and/or abnormal DRE) will be enrolled into a prospective protocol and will undergo detection protocol MRI
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael R Abern, University of Illinois at Chicago
- Investigators
- Michael R Abern, MD, Principal investigator, University of Illinois at Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04175730
- Sponsor's protocol ID
- 2019-0231
- Status last verified
- May 2022
- First submitted
- 28 Oct 2019
- Last updated
- 9 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Cancer Detection Using a Quantitative Screening MRI Protocol
- ClinicalTrials.gov ID
- NCT04175730
- Acronym / sponsor ID
- 2019-0231
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Illinois at ChicagoUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 25 Nov 2019 (actual)
- Results
- Posted 9 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.
Detailed description
This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology clinics. All eligible men will be screened and enrolled by the clinical research coordinator. Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC) prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation in pathology. Biopsy results will be communicated to the patients by the Urologist performing the biopsy and all additional management will be SOC. This visit will signify the end of the study
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 50 men with clinical suspicion of PCa (elevated Prostate specific antigen (PSA) and/or abnormal DRE) will be enrolled into a prospective protocol and will undergo detection protocol MRI
| Arm | Type | Receives |
|---|---|---|
| MRI and Ultrasound | Other | Device: Ultrasound and MRImen with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies |
| Ultrasound | Other | Device: Ultrasoundmen with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult men between 18 and 80 years of age
- Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician
- Ability to provide informed consent
Key exclusion criteria (5 listed)
- Prior prostate biopsy
- Prior diagnosis of PCa
- MRI incompatible implanted medical devices or foreign bodies
- Rectal anatomy incompatible with TRUS biopsy
- Life expectancy <10 years as determined by the treating urologist
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 |
|---|---|---|
| Ultrasound and MRIA single subsequent ultrasound guided prostate biopsy with MRI fusion | Device | MRI and Ultrasound |
| UltrasoundA single subsequent ultrasound guided prostate biopsy | Device | Ultrasound |
Primary outcome
Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology
Time frame: 19 months
Per subject prevalence of any grade or high grade (Gleason score 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Number of Biopsy Samples With a Prevalence of High Grade (Gleason 7 or Higher) Prostate Cancer as Measured by Histopathology
Time frame: 19 months
Per biopsy sample prevalence of high grade (Gleason 7 or higher) prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Number of Participants With PI-RADS 4-5 on MRI
Time frame: 19 months
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Number of Participants With PI-RADS <4 MRI
Time frame: 19 months
The accuracy of the mpMRI (PI-RADS version 2 score) to accurately characterize Gleason 7 or higher prostate cancer as measured by histopathology. When looking at cells under the microscope, the doctor assigns a grade between 1-5. 1 means almost normal and 5 means very different from normal. Adding to two most common grades determines the Gleason score. Higher numbers indicate a faster growing cancer
Number of Participants That Had Adverse Events
Time frame: 19 months
Adverse events of prostate biopsy using the Clavien-Dindo scale
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Michael R Abern, MD principal investigator
University of Illinois at Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and MRI and Ultrasound in people with Prostate Cancer, run by University of Illinois at Chicago at 1 site in United States.
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 9 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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 9 Jun 2022). 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?
Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology (time frame: 19 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jun 2022.