Clinical trial · Interventional
Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
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
NCT04396808CI-TRIAL-00108257active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Decipher | Device | — | UNRESOLVED |
| Oncotype Dx Genomic Prostate Score (GPS) | Device | — | UNRESOLVED |
| Prolaris | Device | — | UNRESOLVED |
| Standard of care (askMUSIC score) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard of care (no pre-treatment genomics testing)
- description
- Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care).
- interventionNames
- Other: Standard of care (askMUSIC score)
- type
- ACTIVE_COMPARATOR
- label
- Standard of care + pre-treatment genomics testing
- description
- 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.
- interventionNames
- Device: Decipher
- Device: Prolaris
- Device: Oncotype Dx Genomic Prostate Score (GPS)
- Other: Standard of care (askMUSIC score)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (1)
- DERIVEDVince 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. PMID 34285350