Prostate CancerNCT04396808
Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
A study testing Decipher, Prolaris and Oncotype Dx Genomic Prostate Score (GPS) in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 8 sites in United States.
Trial summary
This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Decipher, Prolaris and Oncotype Dx Genomic Prostate Score (GPS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 805 participants
- Where
- 8 sitesUnited States
- Study dates
- 5 Nov 2020to Mar 2031
- 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
- Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
- Prostate biopsy tumor tissue (FFPR block) available for processing
- Age 18 years or older
- PSA <20 ng/ml
- Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
- Ability to understand and the willingness to sign a written informed consent. A subject's legally acceptable representative may sign the consent form.
Who cannot join
- Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
- Nodal or metastatic prostate cancer (if staging imaging performed)
- Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
- Prior prostate gene expression classier testing
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
University of North Carolina
Chapel Hill, North Carolina, 27599
Henry Ford Health System
Detroit, Michigan, 48202
Sherwood Medical Center
Detroit, Michigan, 48221
Spectrum Health Medical Group
Grand Rapids, Michigan, 49503
Western Michigan Urological Associates
Holland, Michigan, 49423
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, 19104
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer
This study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.
Read the detailed description
All patients in this study have received or will receive a score from the Michigan Urological Surgery Improvement Collaborative's Cancer of the Prostate Risk Assessment (askMUSIC) scoring system, at the time of enrollment. AskMUSIC is a risk calculator based on standard clinical and pathologic variables and is generally included as part of routine clinical care. The variables used in the risk calculator are prostate-specific antigen (PSA), Gleason score, number of positive core biopsies, number of negative core biopsies, and clinical stage.
Patients will be randomized to either an intervention arm or a control arm. In the control arm, the treating provider will review the askMUSIC score with the patient. In the intervention arm, the treating provider will review the askMUSIC and the GEC score with the patient. Biopsies obtained during the course of standard clinical care will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx Genomic Prostate Score. No additional biopsies will be obtained as part of this study.
After reviewing the results, patients and their treating physicians will decide on a management strategy.
Long-term follow-up will be tracked through the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry.
FEB2026- Amendment was approved to decrease accrual from 900 to 800 as the study had been going on for longer than anticipated due to decreasing enrollment.
- Conditions
- Prostate Cancer
- Being tested
- Decipher, Prolaris, Oncotype Dx Genomic Prostate Score (GPS), Standard of care (askMUSIC score)
- Keywords
- Biomarkers, Active surveillance, Gene Expression Classifier
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DecipherDevice
Also called Decipher Prostate Cancer Classifier
The Decipher test (GenomeDx Biosciences) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.
ProlarisDevice
Also called Prolaris Prostate Cancer Test
The Prolaris test (Myriad Genetics, Inc.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.
Oncotype Dx Genomic Prostate Score (GPS)Device
The Oncotype Dx GPS test (Exact Sciences corp.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision.
Standard of care (askMUSIC score)Other
Also called askMUSIC score
AskMUSIC is a risk calculator based on standard clinical and pathologic variables (https://ask.musicurology.com/) and is generally included as part of routine clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care (no pre-treatment genomics testing) | Active comparator | Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care). Receives: Other: Standard of care (askMUSIC score) |
| Standard of care + pre-treatment genomics testing | Active comparator | Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx. Receives: Device: Decipher; Device: Prolaris; Device: Oncotype Dx Genomic Prostate Score (GPS); Other: Standard of care (askMUSIC score) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binomial proportion of men on active surveillance without treatment
Measured: At 2 years
Secondary outcomes (11)
Occurence of grade reclassification
Grade reclassification defined as an increase in grade group on surveillance biopsy (GG=1 to GG≥2 or GG=2 to GG≥3) for patients managed on active surveillance
Measured: At 2 years
Rate of indolent pathology
To determine the impact of GEC testing on the rate of potentially unnecessary surgery, as defined by indolent pathology at prostatectomy (GG1 and stage pT2).
Measured: At time of prostatectomy (for patients who undergo procedure), up to 2 years
Mean score per arm of patient reported urinary function questionnaire
Assessed by patient reported Expanded Prostate Cancer Index (EPIC) Urinary Incontinence Domain (UIN) questionnaire. Response options form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better quality of life (QOL).
Measured: At 2 years
Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).
Assessed by patient reported EPIC UIN questionnaire. For this measure, MID = 9 points.
Measured: Baseline to 12 months and 2 years
Mean score per arm of patient reported sexual function questionnaire
Assessed by patient reported Expanded Prostate Cancer Index (EPIC) sexual domain questionnaire. Response options form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better QOL.
Measured: At 2 years
Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID).
Assessed by patient reported EPIC sexual function questionnaire. For this measure, MID = 11 points.
Measured: Baseline to 12 months and 2 years
Time to biochemical recurrence (BCR)
Time from treatment PSA >= 0.2 ng/mL for patients undergoing surgery (with PSA at least 5 weeks after surgery) and nadir plus 2.0 ng/mL for patients undergoing radiotherapy.
Measured: From time of radical therapy until the event or the last measured follow-up, up to 2 years
Time to distant metastases
Assessed by CT, MRI, bone scan, and/or PET scan
Measured: From time of radical therapy until the event or the last measured follow-up, up to 2 years
Mean score per arm of health-related quality of life (HRQOL)
Assessed by patient reported Expanded Prostate Cancer Index Composite short form (EPIC-26). EPIC-26 encompasses 5 domains (Urinary Incontinence, Urinary Irritative/Obstructive, Bowel, Sexual, and Hormonal). Response options for each of 26 items form a Likert scale, and multi-item scale scores are transformed linearly to a 0-100 scale, with higher scores representing better HRQOL.
Measured: At 2 years
Rate of adverse pathology at prostatectomy
To determine the performance of GEC testing in predicting adverse pathology, defined as GG≥3 and/or ≥pT3 disease.
Measured: At time of prostatectomy, up to 5 years from enrollment
Rate of biochemical recurrence
To determine the performance of GEC testing in predicting biochemical recurrence, defined as PSA >= 0.2 ng/mL for patients undergoing surgery (with PSA at least 5 weeks after surgery) and nadir plus 2.0 ng/mL for patients undergoing radiotherapy.
Measured: Up to 5 years following treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start5 Nov 2020
- Primary completionMar 2028 (estimated)
- Study completionMar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer CenterThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 1:1 cluster-crossover in 3 month blocks
- Masking
- None (open label)
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Myrexis Inc., Veracyte, Inc., MDx Health, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Todd Morgan, M.D., Principal investigator, University of MichiganDaniel Spratt, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04396808
- Sponsor's protocol ID
- UMCC 2019.132
- Other IDs
- HUM00173277, R01CA240991
- Status last verified
- Apr 2026
- First submitted
- 15 May 2020
- Last updated
- 9 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vince RA Jr, Jiang R, Qi J, Tosoian JJ, Takele R, Feng FY, Linsell S, Johnson A, Shetty S, Hurley P, Miller DC, George A, Ghani K, Sun F, Seymore M, Dess RT, Jackson WC, Schipper M, Spratt DE, Morgan TM. Impact of Decipher Biopsy testing on clinical outcomes in localized prostate cancer in a prospective statewide collaborative. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):677-683. doi: 10.1038/s41391-021-00428-y. Epub 2021 Jul 20.
PubMed 34285350
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR): A Randomized Multi-center Study for Men With Newly Diagnosed Favorable Risk Prostate Cancer
- ClinicalTrials.gov ID
- NCT04396808
- Acronym / sponsor ID
- UMCC 2019.132
- Conditions
- Prostate Cancer
- Keywords
- Biomarkers, Active surveillance, Gene Expression Classifier
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 805 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Myrexis Inc., Veracyte, Inc., MDx Health, National Cancer Institute (NCI)
- Study start
- 5 Nov 2020 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2031 (estimated)
- First posted
- 21 May 2020 (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 study seeks to determine the clinical impact of Gene Expression Classifier (GEC) testing in prostate cancer care while also developing a pragmatic approach for improved GEC clinical use and future study.
Detailed description
All patients in this study have received or will receive a score from the Michigan Urological Surgery Improvement Collaborative's Cancer of the Prostate Risk Assessment (askMUSIC) scoring system, at the time of enrollment. AskMUSIC is a risk calculator based on standard clinical and pathologic variables and is generally included as part of routine clinical care. The variables used in the risk calculator are prostate-specific antigen (PSA), Gleason score, number of positive core biopsies, number of negative core biopsies, and clinical stage.
Patients will be randomized to either an intervention arm or a control arm. In the control arm, the treating provider will review the askMUSIC score with the patient. In the intervention arm, the treating provider will review the askMUSIC and the GEC score with the patient. Biopsies obtained during the course of standard clinical care will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx Genomic Prostate Score. No additional biopsies will be obtained as part of this study.
After reviewing the results, patients and their treating physicians will decide on a management strategy.
Long-term follow-up will be tracked through the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry.
FEB2026- Amendment was approved to decrease accrual from 900 to 800 as the study had been going on for longer than anticipated due to decreasing enrollment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 cluster-crossover in 3 month blocks
| Arm | Type | Receives |
|---|---|---|
| Standard of care (no pre-treatment genomics testing) | Active comparator | Other: Standard of care (askMUSIC score)Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care). |
| Standard of care + pre-treatment genomics testing | Active comparator | Device: Decipher, Device: Prolaris, Device: Oncotype Dx Genomic Prostate Score (GPS), Other: Standard of care (askMUSIC score)Provider will discuss askMUSIC and Gene Expression Classifier (GEC) results with patient prior to deciding on a cancer management strategy. Patients' biopsy tissue will be analyzed using one of the following GECs: Decipher, Prolaris or Oncotype Dx. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Prostate cancer patients who have undergone diagnostic prostate biopsy in the past 9 months.
- Prostate biopsy tumor tissue (FFPR block) available for processing
- Age 18 years or older
- PSA <20 ng/ml
- Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
Key exclusion criteria (4 listed)
- Clinical (on digital rectal exam) or radiographic evidence (if MRI performed) of T3 disease
- Nodal or metastatic prostate cancer (if staging imaging performed)
- Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.
- Prior prostate gene expression classier testing
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 |
|---|---|---|
| DecipherAlso: Decipher Prostate Cancer ClassifierThe Decipher test (GenomeDx Biosciences) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision. | Device | Standard of care + pre-treatment genomics testing |
| ProlarisAlso: Prolaris Prostate Cancer TestThe Prolaris test (Myriad Genetics, Inc.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision. | Device | Standard of care + pre-treatment genomics testing |
| Oncotype Dx Genomic Prostate Score (GPS)The Oncotype Dx GPS test (Exact Sciences corp.) is a genomic test that will be performed on prostate biopsy tissue. Results will be provided to the patient and physician prior to making a treatment decision. | Device | Standard of care + pre-treatment genomics testing |
| Standard of care (askMUSIC score)Also: askMUSIC scoreAskMUSIC is a risk calculator based on standard clinical and pathologic variables (https://ask.musicurology.com/) and is generally included as part of routine clinical care. | Other | Standard of care (no pre-treatment genomics testing), Standard of care + pre-treatment genomics testing |
Primary outcome
Binomial proportion of men on active surveillance without treatment
Time frame: At 2 years
11 secondary outcomes
Occurence of grade reclassification
Time frame: At 2 years
Rate of indolent pathology
Time frame: At time of prostatectomy (for patients who undergo procedure), up to 2 years
Mean score per arm of patient reported urinary function questionnaire
Time frame: At 2 years
Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).
Time frame: Baseline to 12 months and 2 years
Mean score per arm of patient reported sexual function questionnaire
Time frame: At 2 years
Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID).
Time frame: Baseline to 12 months and 2 years
Time to biochemical recurrence (BCR)
Time frame: From time of radical therapy until the event or the last measured follow-up, up to 2 years
Time to distant metastases
Time frame: From time of radical therapy until the event or the last measured follow-up, up to 2 years
Mean score per arm of health-related quality of life (HRQOL)
Time frame: At 2 years
Rate of adverse pathology at prostatectomy
Time frame: At time of prostatectomy, up to 5 years from enrollment
Rate of biochemical recurrence
Time frame: Up to 5 years following treatment
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 9 Sep 2026.
- Derived from this study: PubMed 34285350Vince RA Jr, Jiang R, Qi J, Tosoian JJ, Takele R, Feng FY, Linsell S, Johnson A, Shetty S, Hurley P, Miller DC, George A, Ghani K, Sun F, Seymore M, Dess RT, Jackson WC, Schipper M, Spratt DE, Morgan TM. Impact of Decipher Biopsy testing on clinical outcomes in localized prostate cancer in a prospective statewide collaborative. Prostate Cancer Prostatic Dis. 2022 Apr;25(4):677-683. doi: 10.1038/s41391-021-00428-y. Epub 2021 Jul 20.
- 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.
Todd Morgan, M.D. principal investigator
University of Michigan
Daniel Spratt, M.D. principal investigator
University of Michigan
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decipher, Prolaris and Oncotype Dx Genomic Prostate Score (GPS) in people with Prostate Cancer, run by University of Michigan Rogel Cancer Center at 8 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 6 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 9 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 8 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?
Binomial proportion of men on active surveillance without treatment (time frame: At 2 years). 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 NCT04396808, 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 9 Sep 2026.