Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
NCT ID: NCT04396808
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
900 participants
INTERVENTIONAL
2020-11-05
2031-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
NONE
Study Groups
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Standard of care (no pre-treatment genomics testing)
Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care).
Standard of care (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.
Standard of care + pre-treatment genomics testing
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.
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.
Standard of care (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.
Decipher
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.
Prolaris
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.
Interventions
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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.
Standard of care (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.
Decipher
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.
Prolaris
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
MALE
No
Sponsors
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National Institutes of Health (NIH)
NIH
Myrexis Inc.
INDUSTRY
Veracyte, Inc.
INDUSTRY
MDx Health
INDUSTRY
University of Michigan Rogel Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Todd Morgan, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Daniel Spratt, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States
Henry Ford Health System
Detroit, Michigan, United States
Sherwood Medical Center
Detroit, Michigan, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
Western Michigan Urological Associates
Holland, Michigan, United States
Montefiore Medical Center
The Bronx, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
University of Pennsylvania Perelman School of Medicine
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Conrad Tobert
Role: primary
Ray Tan
Role: primary
References
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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.
Other Identifiers
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HUM00173277
Identifier Type: OTHER
Identifier Source: secondary_id
UMCC 2019.132
Identifier Type: -
Identifier Source: org_study_id
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