PSAP-MRINCT03784924
EDRN Prostate MRI Biomarker Study
An observational study of PSA and Prostate Cancer, run by University of Michigan at 1 site in United States.
Trial summary
The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to… Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- PSA, Prostate Cancer
- What is being tested?
- MRI prostate
- How many people
- 950 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2019to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Urology clinics
Who may be able to join
- Men with suspected but undiagnosed prostate cancer
- To be scheduled/scheduled for biopsy as routine clinical care
Who cannot join
- Inability to obtain blood and urine per SOP or conduct an attentive DRE
- Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
- Prior diagnosis of prostate cancer
- Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
- Participating in clinical trial for prostate disease
- Prior prostate surgery such as TURP, TUNA, TUMT, HOLEP, REZUM, UROlift
- Prior PCA3, TMPRSS2:erg or MIPS panel performed for clinical purpose
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Simpa S Salami, MD, 7346156662, simpa@med.umich.edu
Rabia Martin, 7347637508, rabia@med.umich.edu
About this study
Official title: EDRN Prostate MRI Biomarker Study and Reference Set
The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.
Read the detailed description
The primary aim of this study is to see if the addition of prostate MRI to a panel consisting of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine, blood and tissue biomarkers that will select those cases most likely to benefit from a MRI targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which ones are value added in the setting of initial biopsy, 3) evaluate changes in these biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this study will create a unique, prospective, cohort that will become the foundational reference set for of a range of future biomarker studies.
- Conditions
- PSA, Prostate Cancer
- Being tested
- MRI prostate
- Keywords
- Prostate cancer, psa, early detection, MRI
- Medical subject headings
- Prostatic Neoplasms, Salivary Gland Adenoma, Pleomorphic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI prostateDiagnostic test
Also called urine and blood biomarkers
MRI and laboratory biomarkers
| Study group | Role | What they receive |
|---|---|---|
| Initial prostate biopsy | Men who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy. Receives: Diagnostic Test: MRI prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinically significant prostate cancer
Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start4 Feb 2019
- Primary completion30 Jun 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PSAStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 950 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of Chicago, Cornell University, H. Lee Moffitt Cancer Center and Research Institute, Vanderbilt University, Emory University, University of Miami, University of Texas, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Fred Hutchinson Cancer Center
- Responsible party
- Principal investigator, Simpa Salami, University of Michigan
- Investigators
- John T Wei, MD, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03784924
- Sponsor's protocol ID
- 430
- Acronym
- P-MRI
- Status last verified
- Aug 2026
- First submitted
- 4 Dec 2018
- Last updated
- 17 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EDRN Prostate MRI Biomarker Study and Reference Set
- ClinicalTrials.gov ID
- NCT03784924
- Acronym / sponsor ID
- P-MRI / 430
- Conditions
- PSA, Prostate Cancer
- Keywords
- Prostate cancer, psa, early detection, MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 950 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center at San Antonio, University of Alabama at Birmingham, University of Chicago, Cornell University, H. Lee Moffitt Cancer Center and Research Institute, Vanderbilt University, Emory University, University of Miami, University of Texas, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Fred Hutchinson Cancer Center
- Study start
- 4 Feb 2019 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 24 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The commercialization of MRI fusion biopsies has resulted in a dramatic increase in the use of MRI imaging for prostate cancer. How best to use MRI in the initial prostate biopsy setting given the availability of validated prostate cancer early detection markers is uncertain.This study will allow investigators to determine if prostate MRI is superior to validated panel of laboratory biomarkers (e.g. PCA3, PSA and TMPRSS2:ERG) in the initial biopsy setting.
Detailed description
The primary aim of this study is to see if the addition of prostate MRI to a panel consisting of PSA, PCA3, TMPRSS2:ERG will significantly improve specificity for high-grade prostate cancer by 10%. The subsequent exploratory aims will 1) create an optimal panel of urine, blood and tissue biomarkers that will select those cases most likely to benefit from a MRI targeted biopsy, 2) directly compare PSA and urinary biomarkers with MRI to determine which ones are value added in the setting of initial biopsy, 3) evaluate changes in these biomarkers and MRI to determine if longitudinal changes predict subsequent high-grade prostate cancer, and 4) optimize MRI imaging to improve test performance. Importantly, this study will create a unique, prospective, cohort that will become the foundational reference set for of a range of future biomarker studies.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Initial prostate biopsy | – | Diagnostic Test: MRI prostateMen who have never had a prostate biopsy, but have an elevated risk for prostate cancer such as elevated PSA who are scheduled or considered candidate for an initial prostate biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Urology clinics
Key inclusion criteria (2 listed)
- Men with suspected but undiagnosed prostate cancer
- To be scheduled/scheduled for biopsy as routine clinical care
Key exclusion criteria (7 listed)
- Inability to obtain blood and urine per SOP or conduct an attentive DRE
- Unable to undergo/tolerate a prostate MRI or failure to conduct the MRI
- Prior diagnosis of prostate cancer
- Prior prostate MRI unless being used as Index MRI (in this case index MRI can be one year prior to consent date)
- Participating in clinical trial for prostate disease
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 |
|---|---|---|
| MRI prostateAlso: urine and blood biomarkersMRI and laboratory biomarkers | Diagnostic test | Initial prostate biopsy |
Primary outcome
Clinically significant prostate cancer
Time frame: 2 years
Pathologic diagnosis of prostate cancer with at least Gleason 7 or worse cancer grade on a needle biopsy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for PSA
Not yet recruitingPhase 1/2
RYZ711 Diagnostic Platform Study
Prostate Cancer (Adenocarcinoma), Adenocarcinoma of the Prostate
Not yet recruitingPhase 2
Multitargeted Recombinant Ad5 PSA/MUC-1/Brachyury-Based Immunotherapy (TriAdeno) Vaccine With IL-15 Superagonist N-803 in Participants With Clinically Localized Prostate Cancer Undergoing Active Surveillance
Adenocarcinoma, Prostate Cancer
Recruiting
Prostate Risk Or Radiology Assessment Non-inferiority Design, Upfront MRI or Risk Calculator in Men With Suspected Prostate Cancer
Prostate Cancer
Not yet recruiting
Veteran Peer Navigators to Promote Shared Decision Making for PSA Screening
Prostate Cancer
Active, not recruitingPhase 3
PSMA PET Combined With MRI for the Detection of PCa
PCA, Prostate Cancer
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.
John T Wei, MD, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PSA and Prostate Cancer, run by University of Michigan 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 2 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jackie Dahlgren (206-667-3438, jdahlgre@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically significant prostate cancer (time frame: 2 years). 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 17 Aug 2026.