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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Prostate Cancer
• Intervention / Treatment: Other: Standard of care (askMUSIC score); Device: Decipher; Device: Prolaris; Device: Oncotype Dx Genomic Prostate Score (GPS)

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 Type: Interventional
• Enrollment (Actual): 805
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan Rogel Cancer Center
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
    • Detroit, Michigan, United States, 48221
      • Sherwood Medical Center
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health Medical Group
    • Holland, Michigan, United States, 49423
      • Western Michigan Urological Associates
  • New York
    • The Bronx, New York, United States, 10461
      • Montefiore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania Perelman School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: 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.; Other Names: askMUSIC score
Active Comparator: 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.	Other: 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.; Other Names: askMUSIC score; Device: 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.; Other Names: Decipher Prostate Cancer Classifier; Device: 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 Names: Prolaris Prostate Cancer Test; Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Binomial proportion of men on active surveillance without treatment	At 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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).	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.	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.	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.	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.	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	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.	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.	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.	Up to 5 years following treatment

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH); Myrexis Inc.; Veracyte, Inc.; MDx Health
• Investigators: Principal Investigator: Todd Morgan, M.D., University of Michigan; Principal Investigator: Daniel Spratt, M.D., University of Michigan

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2031

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 15, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Active surveillance; Biomarkers; Gene Expression Classifier
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: UMCC 2019.132; HUM00173277 (Other Identifier: University of Michigan); R01CA240991 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes