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NCT Number: NCT04396808

Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan Rogel Cancer Center, Ann Arbor, Michigan, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Decipher Prostate Cancer Classifier

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.

Other names: Prolaris Prostate Cancer Test

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

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

Primary outcomes

  1. Binomial proportion of men on active surveillance without treatment

    Time frame: At 2 years

Secondary outcomes

  1. Occurence of grade reclassification

    Time frame: At 2 years

    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

  2. Rate of indolent pathology

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

    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).

  3. Mean score per arm of patient reported urinary function questionnaire

    Time frame: At 2 years

    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).

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

    Time frame: Baseline to 12 months and 2 years

    Assessed by patient reported EPIC UIN questionnaire. For this measure, MID = 9 points.

  5. Mean score per arm of patient reported sexual function questionnaire

    Time frame: At 2 years

    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.

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

    Time frame: Baseline to 12 months and 2 years

    Assessed by patient reported EPIC sexual function questionnaire. For this measure, MID = 11 points.

  7. 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 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.

  8. Time to distant metastases

    Time frame: From time of radical therapy until the event or the last measured follow-up, up to 2 years

    Assessed by CT, MRI, bone scan, and/or PET scan

  9. Mean score per arm of health-related quality of life (HRQOL)

    Time frame: At 2 years

    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.

  10. Rate of adverse pathology at prostatectomy

    Time frame: At time of prostatectomy, up to 5 years from enrollment

    To determine the performance of GEC testing in predicting adverse pathology, defined as GG≥3 and/or ≥pT3 disease.

  11. Rate of biochemical recurrence

    Time frame: Up to 5 years following treatment

    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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Collaborators

  • MDx Health
  • Myrexis Inc.
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • Veracyte, Inc.

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2028
Study completion
2031
First posted
May 21, 2020
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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