Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer

NCT04396808 | Active Not Recruiting

• 3 other identifiers: UMCC 2019.132HUM00173277R01CA240991
• Study Type: interventional
• Target: 805
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Prostate Cancer

Keywords

Biomarkers; Active surveillance; Gene Expression Classifier

Outcome Measures

Primary Outcomes (1)

• Binomial proportion of men on active surveillance without treatment

  At 2 years

Secondary Outcomes (11)

• Occurence of grade reclassification

  At 2 years

• Rate of indolent pathology

  At time of prostatectomy (for patients who undergo procedure), up to 2 years

• Mean score per arm of patient reported urinary function questionnaire

  At 2 years

• Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).

  Baseline to 12 months and 2 years

• Mean score per arm of patient reported sexual function questionnaire

  At 2 years

Study Arms (2)

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).

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.

Device: Decipher; Device: Prolaris; Device: Oncotype Dx Genomic Prostate Score (GPS); Other: Standard of care (askMUSIC score)

Interventions

Decipher DEVICE

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.

Also known as: Decipher Prostate Cancer Classifier

Standard of care + pre-treatment genomics testing

Prolaris DEVICE

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.

Also known as: Prolaris Prostate Cancer Test

Standard of care + pre-treatment genomics testing

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 + pre-treatment genomics testing

Standard of care (askMUSIC score) OTHER

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.

Also known as: askMUSIC score

Standard of care (no pre-treatment genomics testing); Standard of care + pre-treatment genomics testing

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Veracyte, Inc.: collaborator
• MDx Health: collaborator
• National Institutes of Health (NIH): collaborator
• Myrexis Inc.: collaborator
• University of Michigan Rogel Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Sherwood Medical Center

Detroit, Michigan, 48221, United States

Location

Spectrum Health Medical Group

Grand Rapids, Michigan, 49503, United States

Location

Western Michigan Urological Associates

Holland, Michigan, 49423, United States

Location

Montefiore Medical Center

The Bronx, New York, 10461, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

University of Pennsylvania Perelman School of Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• 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.

  PMID: 34285350 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Todd Morgan, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

• Daniel Spratt, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1:1 cluster-crossover in 3 month blocks

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 21, 2020
• Study Start: November 5, 2020
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)