Prostate CarcinomaNCT03697148
Multiparametric MRI in Evaluating Cancer Stage and Helping Treatment Planning in Patients With Prostate Cancer
A study testing Multiparametric Magnetic Resonance Imaging in people with Prostate Carcinoma, run by ECOG-ACRIN Cancer Research Group at 44 sites in United States.
Trial summary
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Multiparametric Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 44 sitesUnited States
- Study dates
- 11 Feb 2019to 31 Dec 2026
- Phase
- Interventional
- 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
Who may be able to join
- Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated
Who cannot join
- Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
- Prior surgical and/or non-surgical treatment for prostate cancer
- Prior hip replacement or other major pelvic surgery
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Pali Momi Medical Center
‘Aiea, Hawaii, 96701
Straub Pearlridge Clinic
‘Aiea, Hawaii, 96701
Brigham and Women's Hospital
Boston, Massachusetts, 02115
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
MD Anderson in The Woodlands
Conroe, Texas, 77384
UT Southwestern/Simmons Cancer Center-Dallas
Dallas, Texas, 75390
Henry Ford Hospital
Detroit, Michigan, 48202
Corewell Health Grand Rapids Hospitals - Butterworth Hospital
Grand Rapids, Michigan, 49503
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
Queen's Medical Center
Honolulu, Hawaii, 96813
Straub Clinic and Hospital
Honolulu, Hawaii, 96813
M D Anderson Cancer Center
Houston, Texas, 77030
MD Anderson West Houston
Houston, Texas, 77079
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
University of Iowa/Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242
University of Florida Health Science Center - Jacksonville
Jacksonville, Florida, 32209
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
University of Kansas Cancer Center
Kansas City, Kansas, 66160
MD Anderson League City
League City, Texas, 77573
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, 03756
Asante Rogue Regional Medical Center
Medford, Oregon, 97504
East Jefferson General Hospital
Metairie, Louisiana, 70006
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Metairie, Louisiana, 70006
West Virginia University Healthcare
Morgantown, West Virginia, 26506
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, 37232
Yale University
New Haven, Connecticut, 06520
NYP/Weill Cornell Medical Center
New York, New York, 10065
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, 66211
University of Pennsylvania/Abramson Cancer Center
Philadelphia, Pennsylvania, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Mayo Clinic Hospital in Arizona
Phoenix, Arizona, 85054
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Audie L Murphy VA Hospital
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Washington University School of Medicine
St Louis, Missouri, 63110
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Stony Brook University Medical Center
Stony Brook, New York, 11794
MD Anderson in Sugar Land
Sugar Land, Texas, 77478
ProHealth Waukesha Memorial Hospital
Waukesha, Wisconsin, 53188
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, 53188
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Midwestern Regional Medical Center
Zion, Illinois, 60099
About this study
Official title: Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
Read the detailed description
PRIMARY OBJECTIVES:
- To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer.
II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer.
SECONDARY OBJECTIVES:
- To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review.
TERTIARY OBJECTIVES:
- All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims.
OUTLINE:
Patients undergo mpMRI within 3 months prior to schedule surgery.
After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.
- Conditions
- Prostate Carcinoma
- Being tested
- Multiparametric Magnetic Resonance Imaging
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiparametric Magnetic Resonance ImagingDiagnostic test
Also called MP-MRI, Multi-parametric MRI, Multiparametric MRI
Undergo mpMRI
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (mpMRI) | Experimental | Patients undergo mpMRI within 3 months prior to schedule surgery. Receives: Diagnostic Test: Multiparametric Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score
Will estimate the diagnostic performance as quantified by the area under the ROC curve.
Measured: Up to 2 years
Risk prediction model
To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage.
Measured: Up to 2 years
Secondary outcomes (1)
Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score
Will estimate the diagnostic performance as quantified by the area under the ROC curve.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2018
- Study start11 Feb 2019
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by ECOG-ACRIN Cancer Research GroupThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 852 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ECOG-ACRIN Cancer Research Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Clare Tempany-Afdhal, Principal investigator, ECOG-ACRIN Cancer Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03697148
- Sponsor's protocol ID
- EA8171
- Other IDs
- NCI-2017-01997, EA8171, EA8171, U10CA180820
- Status last verified
- Sep 2026
- First submitted
- 10 Jul 2018
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer
- ClinicalTrials.gov ID
- NCT03697148
- Acronym / sponsor ID
- EA8171
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 852 participants (estimated)
- Lead sponsor
- ECOG-ACRIN Cancer Research GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 11 Feb 2019 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Oct 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.
This phase II trial studies how well multiparametric magnetic resonance imaging (MRI) works in evaluating cancer stage and helping treatment planning in patients with prostate cancer. Multiparametric MRI may be useful for evaluating the type of cancer in finding aggressive disease.
Detailed description
PRIMARY OBJECTIVES:
- To estimate the diagnostic performance as quantified by the area under the ROC curve to detect aggressive prostate cancer.
II. To develop a risk prediction model by incorporating overall PI-RADS, PSA, Gleason score and clinical stage to predict the presence of aggressive prostate cancer.
SECONDARY OBJECTIVES:
- To evaluate the diagnostic performance of the individual PI-RADS score of each MRI parameter (T2W, DWI and DCE), as determined by local imaging review.
TERTIARY OBJECTIVES:
- All clinical data including magnetic resonance (MR) images will be banked for future exploratory research aims.
OUTLINE:
Patients undergo mpMRI within 3 months prior to schedule surgery.
After completion of study, patients are followed up until radical prostatectomy pathology is reported and finalized.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (mpMRI) | Experimental | Diagnostic Test: Multiparametric Magnetic Resonance ImagingPatients undergo mpMRI within 3 months prior to schedule surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Recently diagnosed with prostate cancer for whom definitive surgical treatment is indicated
Key exclusion criteria (3 listed)
- Not suitable to undergo MRI or receive gadolinium-based contrast agent (severe, untreatable claustrophobia; MRI-incompatible metallic objects or implanted medical devices; renal failure; weight greater than allowable by scanner per institutional standard practice)
- Prior surgical and/or non-surgical treatment for prostate cancer
- Prior hip replacement or other major pelvic surgery
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 |
|---|---|---|
| Multiparametric Magnetic Resonance ImagingAlso: MP-MRI, Multi-parametric MRI, Multiparametric MRIUndergo mpMRI | Diagnostic test | Diagnostic (mpMRI) |
Primary outcome
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score
Time frame: Up to 2 years
Will estimate the diagnostic performance as quantified by the area under the ROC curve.
Risk prediction model
Time frame: Up to 2 years
To estimate the predictive performance of a model for predicting clinically significant prostate cancer on the basis of the overall PI-RADS, PSA, Gleason score and clinical stage.
1 secondary outcome
Diagnostic performance of the individual prostate imaging reporting and data system (PI-RADS) score
Time frame: Up to 2 years
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 15 Sep 2026.
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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.
Clare Tempany-Afdhal principal investigator
ECOG-ACRIN Cancer Research Group
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiparametric Magnetic Resonance Imaging in people with Prostate Carcinoma, run by ECOG-ACRIN Cancer Research Group at 44 sites 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 1 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites 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?
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?
Diagnostic performance of overall prostate imaging reporting and data system (PI-RADS) score (time frame: Up to 2 years). The study lists 2 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 15 Sep 2026.