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

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ClinicalTrials.gov Identifier: NCT04396808
Recruitment Status : Recruiting
First Posted : May 21, 2020
Last Update Posted : October 28, 2021
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Decipher Device: Prolaris Device: Oncotype Dx Genomic Prostate Score (GPS) Other: Standard of care (askMUSIC score) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 1:1 cluster-crossover in 3 month blocks
Masking: None (Open Label)
Primary Purpose: Other
Official 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
Actual Study Start Date : November 5, 2020
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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 Name: 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.
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 Name: 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 Name: 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.

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 Name: askMUSIC score




Primary Outcome Measures :
  1. Binomial proportion of men on active surveillance without treatment [ Time Frame: At 2 years ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04396808


Contacts
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Contact: G-Major Study 734-764-4060 gmajorstudy@med.umich.edu

Locations
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United States, Michigan
University of Michigan Rogel Cancer Center Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: G-Major Study    734-764-4060    gmajorstudy@med.umich.edu   
Principal Investigator: Todd Morgan, M.D.         
Sub-Investigator: Daniel Spratt, M.D.         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: Craig Rogers, MD         
Sherwood Medical Center Recruiting
Detroit, Michigan, United States, 48221
Principal Investigator: Conrad Maitland, MD         
Western Michigan Urological Associates Recruiting
Holland, Michigan, United States, 49423
Principal Investigator: John Ludlow, MD         
Sponsors and Collaborators
University of Michigan Rogel Cancer Center
National Institutes of Health (NIH)
Investigators
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Principal Investigator: Todd Morgan, M.D. University of Michigan
Principal Investigator: Daniel Spratt, M.D. University of Michigan
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Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT04396808    
Other Study ID Numbers: UMCC 2019.132
HUM00173277 ( Other Identifier: University of Michigan )
First Posted: May 21, 2020    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of Michigan Rogel Cancer Center:
Biomarkers
Active surveillance
Gene Expression Classifier
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases