Prostate CancerMAGICNCT05424783
MRI And GPS Informing Choices for Prostate Cancer Treatment (MAGIC)
An observational study of Prostate Cancer, run by Northwestern University at 2 sites in United States.
Trial summary
The overarching goal is to prospectively recruit men considering active surveillance for treatment in the MAGIC (MRI And GPS Informing Choices for prostate cancer treatment) Cohort to provide meaningful data on active surveillance in Blacks and in men served in safety net hospitals. Read more about this study
- Who is it for?
- Ages 40 to 76 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate
- How many people
- 222 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Oct 2022to 1 Feb 2027
- 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 40 to 76 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: The target population for this study is participants with newly diagnosed favorable risk prostate cancer who are eligible for active surveillance for Prostate Cancer.
Who may be able to join
- Participants must have NCCN very low to favorable intermediate risk prostate cancer.
- Participants must be diagnosed within 3 months prior to study enrollment.
- Participants must be male, age 40-76 years old.
- Participants must be willing to consider active surveillance for treatment.
Who cannot join
- Participants with less than 10 years life expectancy.
- Participants unable to complete standardized surveys.
- Participants with no access to the rectum for a transrectal ultrasound.
- Participants with a contraindication to magnetic resonance imaging (MRI).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Northwestern University
Chicago, Illinois, 60611
University of Illinois at Chicago
Chicago, Illinois, 60612
About this study
Official title: Expanding an Active Surveillance Cohort to Improve Survivorship for Men With Favorable Risk Prostate Cancer
The overarching goal is to prospectively recruit men considering active surveillance for treatment in the MAGIC (MRI And GPS Informing Choices for prostate cancer treatment) Cohort to provide meaningful data on active surveillance in Blacks and in men served in safety net hospitals. Recent studies highlight significant promise for multi-parametric magnetic resonance imaging of the prostate (MRI) and Genomic Prostate Score assay (GPS) as tools to help risk stratify men on active surveillance to identify men likely to harbor undetected aggressive disease in their prostate. Given the risk data provided by these modalities and the low adherence with monitoring common in men served in public hospitals, both tools may improve safety via improved patient selection and patient adherence with monitoring. The downside is that excessive testing may lead to too many false positives and unnecessary treatment. Two hundred men with very low to intermediate risk prostate cancer were randomized into the 2-arm ENACT Clinical trial from 2016-2019 to study the impact of the GPS assay on treatment choice. Overall, 104 men received GPS assay and 96 controls did not receive the assay (a confirmatory test) right after being newly diagnosed with favorable risk prostate cancer.
For Aim 1, 222 men will be recruited into the MRI And GPS Informing Choices for prostate cancer treatment (MAGIC) study and they will be given the GPS assay and multi-parametric MRI of the prostate to provide personalized risk data for having aggressive tumors in their prostate. Between the ENACT and MAGIC study, there will be 3 groups of men who will have received both GPS \& MRI, GPS alone, or neither test and can compare the impact of having 0,1 or 2 confirmatory tests on patient's adherence to active surveillance monitoring protocols over 18 months. The analyses will elucidate whether 1 or 2 tests are needed to improve adherence to monitoring. Monitoring is vital for detecting tumor progression early and avoiding cancer metastasis and death.
Read more
In Aim 2, the MAGIC study cohort will be leveraged to determine the accuracy of the Genomic Prostate Score assay and the prostate imaging- reporting and data system (PIRADS) score from the MRI in predicting which tumors will progress in 18 months. Progression is defined as increased Gleason grade group (GG) or change in prostate digital rectal examination findings. This serves two purposes. It will allow doctors and patients to categorize the patient as safe or risky for active surveillance. Secondly, it will allow doctors to identify which men on active surveillance need to be followed with annual prostate biopsies and which men can have their biopsies deferred for 3-5 years to reduce the number of prostate biopsies and their morbidities.
Lastly in Aim 3, the participants will rank the importance of these tests among a multitude of clinical, social, financial and interpersonal influences on their cancer treatment choice. By tallying the patient rankings, one can identify the most critical decision making factors that can be used to encourage increased selection of active surveillance.
Read the detailed description
Active surveillance (AS) avoids or delays prostate cancer (PCa) treatment side effects for survivors. Blacks and men of lower socioeconomic status (SES) under-utilize this monitoring approach. Previous work has demonstrated that Genomic Prostate Score assay (GPS) is accurate in detecting adverse pathology at radical prostatectomy in Black and White men eligible for AS. One small study showed that Genomic Prostate Score (GPS) can predict tumor progression in 3 years. ENACT was closed to enrollment in 2019 and there were 200 men eligible for AS of lower SES enrolled into a randomized clinical trial assessing the impact of the GPS on patient treatment choice. AS was chosen by 77% of the participants for primary treatment and 72.1% of them were Black. The ENACT cohort now represents the second largest cohort of Black men on AS (n=112) with a median follow-up of 3 years. Moreover, recruitment took place at a Veterans Administration hospital, a County hospital and a state-funded University medical center serving men from with low rates of private insurance and a range of health literacy levels, thus complementing the data available from most AS cohorts. The long term goal is to reduce PCa over-treatment by improving the safety and acceptability of AS for men at higher risk for aggressive PCa. Multiparametric MRI of the prostate (mpMRI) has similarly been shown to predict tumor progression and Hence, the study will assess the accuracy of GPS for tumor progression, assess the impact of GPS on adherence to AS monitoring, and identify factors affecting AS selection in men of lower SES.
Aim 1. Assess the accuracy of the Genomic Prostate Score in a Black-enriched cohort to identify disease progression while on Active Surveillance over 3 years.
Methods: 66 of the 140 men on AS were randomized to receive the GPS. GPS tests will be performed on the 74 control participants' biopsies and coordinators will track all of the men for tumor progression (increase in Gleason score) on first AS prostate biopsy (PB) at 12-18 months. Tumor progression will be coded as Yes/No and receiver operating characteristics will be calculated for GPS while controlling for National Comprehensive Cancer Network (NCCN) risk group, age and race.
Aim 2. Compare the degree of adherence with NCCN active surveillance protocol at 18 months in men initially randomized to the GPS Intervention vs. Control group.
Methods: 140 of 200 men elected AS for initial treatment (101 Black/39 non-Black). As of January 2020, 3 men were lost to follow up. The proportion of men completing their surveillance prostate biopsy (PB) will be assessed at 18 months and there will be an assessment of the median number of prostate specific antigen (PSA) tests and digital rectal exams (DREs) completed per year between the 66 men randomized to the GPS on AS and the 74 controls.
Aim 3. Identify the main barriers and facilitators to initial active surveillance selection in a Black-enriched population.
Methods: Aim 3 leverage the clinical trial data and participants. All participants will be administered a survey to identify which factors encouraged or discouraged them from choosing AS, including patient and tumor factors, urologist treatment and decision making preference, and the GPS assay. There will be measures for medical mistrust, social support, employment status, insurance status, transportation and financial concerns, interactions with other PCa patients, and fear of job loss, side effects, surgery or of radiotherapy.
- Conditions
- Prostate Cancer
- Being tested
- Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostateOther
Also called GPS assay + mp-MRI
The Genomic Prostate Score is a 17 gene relative expression assay used to predict the presence of adverse pathologic findings at radical prostatectomy. This test is used to determine appropriateness for active surveillance. Prostate MRI is a prostate imaging test that has been shown to improve the detection of clinically significant prostate cancer using a PI-RADS scoring system. It relies on T2-weighted imaging, diffusion weighted imaging, dynamic contrast enhancement, and apparent diffusion coefficient to differentiate prostate cancer from normal prostate parenchyma and prostatitis.
| Study group | Role | What they receive |
|---|---|---|
| Genomic Prostate Score assay and multi-parametric MRI of the prostate | Men with newly diagnosed NCCN very low to favorable intermediate risk prostate cancer will be enrolled at their post biopsy urologist visit. Once enrolled, participants will have their prostate tissue sent off for their Genomic Prostate Score assay and men will undergo a prostate MRI to evaluate for potentially missed clinically significant prostate cancer. In a subsequent urologist visit, participants will choose their treatment choice. Men who choose active surveillance for their primary treatment choice will be monitored per clinical routine by PSA, digital rectal exam, and active surveillance prostate biopsy in 12-18 months. After month 6, men will be followed through their electronic medical records system to track adherence to their 12-18 month active surveillance prostate biopsy. Receives: Other: Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of men who had an active surveillance prostate biopsy by 18 months
The men in the MAGIC study who chose active surveillance that complete their active surveillance prostate biopsy by 18 months after their diagnostic prostate biopsy will be compared to men who chose active surveillance in the ENACT Clinical Trial who received GPS alone (ENACT intervention arm) or neither GPS nor prostate MRI (ENACT control arm).
Measured: 18 months after diagnostic prostate biopsy
Secondary outcomes (1)
The proportion of men with reclassification within 18 months
The proportion of men with reclassification within 18 months of Visit 1 will be compared between the three groups: ENACT Control, ENACT GPS Intervention, MAGIC cohort.
Measured: 18 months after diagnostic prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start15 Oct 2022
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Adam Murphy, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05424783
- Sponsor's protocol ID
- STU00215555
- Acronym
- MAGIC
- Status last verified
- Aug 2026
- First submitted
- 15 Jun 2022
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Northwestern University and University of Illinois at Chicago are committed to making databases from clinical protocols available to interested investigators. This is subject to appropriate safeguards regarding protection of subjects' personal data. The first level of access will be to the investigators who have been involved in the conduct of the study. A second level is to the university for financial concerns around intellectual property and patents. Data can be provided in aggregate or at an individual level as an analytic database. The preferred format is a SPSS or SAS data set. These data sets will not contain subject identifying information. Once the proposed study is complete and the primary manuscript has been published, both character and analytic databases will be archived.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding an Active Surveillance Cohort to Improve Survivorship for Men With Favorable Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT05424783
- Acronym / sponsor ID
- MAGIC / STU00215555
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 21 Jun 2022 (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 overarching goal is to prospectively recruit men considering active surveillance for treatment in the MAGIC (MRI And GPS Informing Choices for prostate cancer treatment) Cohort to provide meaningful data on active surveillance in Blacks and in men served in safety net hospitals. Recent studies highlight significant promise for multi-parametric magnetic resonance imaging of the prostate (MRI) and Genomic Prostate Score assay (GPS) as tools to help risk stratify men on active surveillance to identify men likely to harbor undetected aggressive disease in their prostate. Given the risk data provided by these modalities and the low adherence with monitoring common in men served in public hospitals, both tools may improve safety via improved patient selection and patient adherence with monitoring. The downside is that excessive testing may lead to too many false positives and unnecessary treatment. Two hundred men with very low to intermediate risk prostate cancer were randomized into the 2-arm ENACT Clinical trial from 2016-2019 to study the impact of the GPS assay on treatment choice. Overall, 104 men received GPS assay and 96 controls did not receive the assay (a confirmatory test) right after being newly diagnosed with favorable risk prostate cancer.
For Aim 1, 222 men will be recruited into the MRI And GPS Informing Choices for prostate cancer treatment (MAGIC) study and they will be given the GPS assay and multi-parametric MRI of the prostate to provide personalized risk data for having aggressive tumors in their prostate. Between the ENACT and MAGIC study, there will be 3 groups of men who will have received both GPS \& MRI, GPS alone, or neither test and can compare the impact of having 0,1 or 2 confirmatory tests on patient's adherence to active surveillance monitoring protocols over 18 months. The analyses will elucidate whether 1 or 2 tests are needed to improve adherence to monitoring. Monitoring is vital for detecting tumor progression early and avoiding cancer metastasis and death.
In Aim 2, the MAGIC study cohort will be leveraged to determine the accuracy of the Genomic Prostate Score assay and the prostate imaging- reporting and data system (PIRADS) score from the MRI in predicting which tumors will progress in 18 months. Progression is defined as increased Gleason grade group (GG) or change in prostate digital rectal examination findings. This serves two purposes. It will allow doctors and patients to categorize the patient as safe or risky for active surveillance. Secondly, it will allow doctors to identify which men on active surveillance need to be followed with annual prostate biopsies and which men can have their biopsies deferred for 3-5 years to reduce the number of prostate biopsies and their morbidities.
Lastly in Aim 3, the participants will rank the importance of these tests among a multitude of clinical, social, financial and interpersonal influences on their cancer treatment choice. By tallying the patient rankings, one can identify the most critical decision making factors that can be used to encourage increased selection of active surveillance.
Detailed description
Active surveillance (AS) avoids or delays prostate cancer (PCa) treatment side effects for survivors. Blacks and men of lower socioeconomic status (SES) under-utilize this monitoring approach. Previous work has demonstrated that Genomic Prostate Score assay (GPS) is accurate in detecting adverse pathology at radical prostatectomy in Black and White men eligible for AS. One small study showed that Genomic Prostate Score (GPS) can predict tumor progression in 3 years. ENACT was closed to enrollment in 2019 and there were 200 men eligible for AS of lower SES enrolled into a randomized clinical trial assessing the impact of the GPS on patient treatment choice. AS was chosen by 77% of the participants for primary treatment and 72.1% of them were Black. The ENACT cohort now represents the second largest cohort of Black men on AS (n=112) with a median follow-up of 3 years. Moreover, recruitment took place at a Veterans Administration hospital, a County hospital and a state-funded University medical center serving men from with low rates of private insurance and a range of health literacy levels, thus complementing the data available from most AS cohorts. The long term goal is to reduce PCa over-treatment by improving the safety and acceptability of AS for men at higher risk for aggressive PCa. Multiparametric MRI of the prostate (mpMRI) has similarly been shown to predict tumor progression and Hence, the study will assess the accuracy of GPS for tumor progression, assess the impact of GPS on adherence to AS monitoring, and identify factors affecting AS selection in men of lower SES.
Aim 1. Assess the accuracy of the Genomic Prostate Score in a Black-enriched cohort to identify disease progression while on Active Surveillance over 3 years.
Methods: 66 of the 140 men on AS were randomized to receive the GPS. GPS tests will be performed on the 74 control participants' biopsies and coordinators will track all of the men for tumor progression (increase in Gleason score) on first AS prostate biopsy (PB) at 12-18 months. Tumor progression will be coded as Yes/No and receiver operating characteristics will be calculated for GPS while controlling for National Comprehensive Cancer Network (NCCN) risk group, age and race.
Aim 2. Compare the degree of adherence with NCCN active surveillance protocol at 18 months in men initially randomized to the GPS Intervention vs. Control group.
Methods: 140 of 200 men elected AS for initial treatment (101 Black/39 non-Black). As of January 2020, 3 men were lost to follow up. The proportion of men completing their surveillance prostate biopsy (PB) will be assessed at 18 months and there will be an assessment of the median number of prostate specific antigen (PSA) tests and digital rectal exams (DREs) completed per year between the 66 men randomized to the GPS on AS and the 74 controls.
Aim 3. Identify the main barriers and facilitators to initial active surveillance selection in a Black-enriched population.
Methods: Aim 3 leverage the clinical trial data and participants. All participants will be administered a survey to identify which factors encouraged or discouraged them from choosing AS, including patient and tumor factors, urologist treatment and decision making preference, and the GPS assay. There will be measures for medical mistrust, social support, employment status, insurance status, transportation and financial concerns, interactions with other PCa patients, and fear of job loss, side effects, surgery or of radiotherapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Genomic Prostate Score assay and multi-parametric MRI of the prostate | – | Other: Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostateMen with newly diagnosed NCCN very low to favorable intermediate risk prostate cancer will be enrolled at their post biopsy urologist visit. Once enrolled, participants will have their prostate tissue sent off for their Genomic Prostate Score assay and men will undergo a prostate MRI to evaluate for potentially missed clinically significant prostate cancer. In a subsequent urologist visit, participants will choose their treatment choice. Men who choose active surveillance for their primary treatment choice will be monitored per clinical routine by PSA, digital rectal exam, and active surveillance prostate biopsy in 12-18 months. After month 6, men will be followed through their electronic medical records system to track adherence to their 12-18 month active surveillance prostate biopsy. |
Who may qualify
- Ages
- 40 to 76 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The target population for this study is participants with newly diagnosed favorable risk prostate cancer who are eligible for active surveillance for Prostate Cancer.
Key inclusion criteria (4 listed)
- Participants must have NCCN very low to favorable intermediate risk prostate cancer.
- Participants must be diagnosed within 3 months prior to study enrollment.
- Participants must be male, age 40-76 years old.
- Participants must be willing to consider active surveillance for treatment.
Key exclusion criteria (4 listed)
- Participants with less than 10 years life expectancy.
- Participants unable to complete standardized surveys.
- Participants with no access to the rectum for a transrectal ultrasound.
- Participants with a contraindication to magnetic resonance imaging (MRI).
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 |
|---|---|---|
| Genomic Prostate Score assay and Multi-parametric magnetic resonance imaging study of the prostateAlso: GPS assay + mp-MRIThe Genomic Prostate Score is a 17 gene relative expression assay used to predict the presence of adverse pathologic findings at radical prostatectomy. This test is used to determine appropriateness for active surveillance. Prostate MRI is a prostate imaging test that has been shown to improve the detection of clinically significant prostate cancer using a PI-RADS scoring system. It relies on T2-weighted imaging, diffusion weighted imaging, dynamic contrast enhancement, and apparent diffusion coefficient to differentiate prostate cancer from normal prostate parenchyma and prostatitis. | Other | Genomic Prostate Score assay and multi-parametric MRI of the prostate |
Primary outcome
Proportion of men who had an active surveillance prostate biopsy by 18 months
Time frame: 18 months after diagnostic prostate biopsy
The men in the MAGIC study who chose active surveillance that complete their active surveillance prostate biopsy by 18 months after their diagnostic prostate biopsy will be compared to men who chose active surveillance in the ENACT Clinical Trial who received GPS alone (ENACT intervention arm) or neither GPS nor prostate MRI (ENACT control arm).
1 secondary outcome
The proportion of men with reclassification within 18 months
Time frame: 18 months after diagnostic prostate 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 19 Aug 2026.
- Individual participant dataSharing planned: Yes. Northwestern University and University of Illinois at Chicago are committed to making databases from clinical protocols available to interested investigators. This is subject to appropriate safeguards regarding protection of subjects' personal data. The first level of access will be to the investigators who have been involved in the conduct of the study. A second level is to the university for financial concerns around intellectual property and patents. Data can be provided in aggregate or at an individual level as an analytic database. The preferred format is a SPSS or SAS data set. These data sets will not contain subject identifying information. Once the proposed study is complete and the primary manuscript has been published, both character and analytic databases will be archived.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Northwestern University at 2 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 4 inclusion and 4 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 19 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 2 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?
Proportion of men who had an active surveillance prostate biopsy by 18 months (time frame: 18 months after diagnostic prostate biopsy). 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 19 Aug 2026.