Genomics in Michigan to AdJust Outcomes in Prostate canceR (G-MAJOR) for Men With Newly Diagnosed Favorable Risk Prostate Cancer
Status
RECRUITING
Phase
NA
Age
≥ 18 Years
Enrollments
900Conditions
Prostate CancerSummary
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.
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.
Locations
8 locations Found with status Recruiting
Status
- RECRUITING
Contact Person
- G-Major Study
- 734-764-4060
- [email protected]
Principal Investigator
- Todd Morgan, M.D.
Status
- RECRUITING
Contact Person
- Craig Rogers, MD
Principal Investigator
- Todd Morgan, M.D.
Status
- RECRUITING
Contact Person
- Conrad Maitland, MD
Principal Investigator
- Todd Morgan, M.D.
Status
- RECRUITING
Contact Person
- Conrad Tobert
Principal Investigator
- Todd Morgan, M.D.
Status
- RECRUITING
Contact Person
- John Ludlow, MD
Principal Investigator
- Todd Morgan, M.D.
Status
- RECRUITING
Contact Person
- Andarea Asencio
- 718-741-2426
- [email protected]
Principal Investigator
- Todd Morgan, M.D.
Status
- RECRUITING
Contact Person
- Ray Tan
Principal Investigator
- Todd Morgan, M.D.
Status
- RECRUITING
Contact Person
- Hanna Stambakio
- 215-614-5039
- [email protected]
Principal Investigator
- Todd Morgan, M.D.
Eligibility 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
Study Plan
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)Description:
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.
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:
DecipherDescription:
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.DEVICE:
ProlarisDescription:
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.DEVICE:
Oncotype Dx Genomic Prostate Score (GPS)Description:
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)Description:
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.
Outcome Measures
Primary Outcome Measures
Binomial proportion of men on active surveillance without treatment
Secondary Outcome Measures
Occurence of grade reclassification
Rate of indolent pathology
Mean score per arm of patient reported urinary function questionnaire
Proportion of patients with changes from baseline in urinary function exceeding Minimal Important Differences (MID).
Mean score per arm of patient reported sexual function questionnaire
Proportion of patients with changes from baseline in sexual function exceeding Minimal Important Differences (MID).
Time to biochemical recurrence (BCR)
Time to distant metastases
Mean score per arm of health-related quality of life (HRQOL)
Rate of adverse pathology at prostatectomy
Rate of biochemical recurrence
Timeline
Last Updated
September 3, 2024Start Date
May 21, 2020Today
January 23, 2025Completion Date ( Estimated )
July 1, 2025
Sponsors of this trial
Lead Sponsor
University of Michigan Rogel Cancer CenterCollaborating Sponsors
National Institutes of Health (NIH), Myrexis Inc., Veracyte, Inc., MDx Health
RECRUITING 
21 - 64 Years