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Gene Expression Classifier
Standard of care (no pre-treatment genomics testing) for Prostate Cancer
N/A
Recruiting
Led By Todd Morgan, M.D.
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Grade Group (GG) 1 cancer with > 2 biopsy cores involved with cancer OR GG2 cancer
Age 18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years following treatment
Awards & highlights
Study Summary
This trial will help researchers understand if a certain type of genetic testing can help improve treatment for prostate cancer patients, as well as how best to use this testing in the future.
Who is the study for?
This trial is for men 18 or older with newly diagnosed favorable risk prostate cancer, having a PSA level below 20 ng/ml. Participants must have had a diagnostic biopsy within the last 9 months and have available tissue samples. It's suitable for those with Grade Group 1 cancer involving more than two biopsy cores or Grade Group 2 cancer. Men who've already had gene expression classifier testing or any prostate cancer treatment are excluded.Check my eligibility
What is being tested?
The G-MAJOR study is evaluating the impact of Gene Expression Classifier (GEC) tests like Prolaris, Decipher, and Oncotype Dx GPS on managing prostate cancer compared to standard care based on askMUSIC scores. The goal is to refine how these genomic tests are used in clinical practice and set up future research.See study design
What are the potential side effects?
Since this trial focuses on genomic testing rather than drug interventions, traditional side effects associated with medications aren't expected. However, there may be some risks related to data privacy and potential emotional impacts from learning about one's genetic risk factors.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My prostate cancer is either low grade with more than 2 biopsy cores involved or is moderate grade.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years following treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years following treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Therapeutic procedure
Secondary outcome measures
Mean score per arm of health-related quality of life (HRQOL)
Mean score per arm of patient reported sexual function questionnaire
Mean score per arm of patient reported urinary function questionnaire
+8 moreTrial Design
2Treatment groups
Active Control
Group I: Standard of care (no pre-treatment genomics testing)Active Control1 Intervention
Provider will discuss askMUSIC results with patient prior to deciding on a management strategy (standard of care).
Group II: Standard of care + pre-treatment genomics testingActive Control4 Interventions
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Prostate cancer treatments primarily target the androgen receptor pathway, which is crucial for prostate cancer cell growth. Androgen deprivation therapy (ADT) reduces androgen levels or blocks androgen receptors, thereby inhibiting cancer cell proliferation.
Radiation therapy uses high-energy rays to damage the DNA of cancer cells, leading to cell death. Chemotherapy involves drugs that kill rapidly dividing cells, including cancer cells.
Gene expression classifiers, like the ones studied in the Gene Expression Classifier trial, analyze the activity of specific genes to predict how a patient's cancer will respond to these treatments. This personalized approach can help optimize treatment plans, improving outcomes and minimizing unnecessary side effects for prostate cancer patients.
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Who is running the clinical trial?
MDx HealthIndustry Sponsor
4 Previous Clinical Trials
3,378 Total Patients Enrolled
2 Trials studying Prostate Cancer
1,600 Patients Enrolled for Prostate Cancer
Veracyte, Inc.Industry Sponsor
4 Previous Clinical Trials
1,003,393 Total Patients Enrolled
2 Trials studying Prostate Cancer
1,000,493 Patients Enrolled for Prostate Cancer
National Institutes of Health (NIH)NIH
2,723 Previous Clinical Trials
7,494,846 Total Patients Enrolled
28 Trials studying Prostate Cancer
6,057 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can understand and am willing to sign the consent form, or I have someone who can legally do it for me.I have had gene testing for prostate cancer.I have had treatment for prostate cancer before.My cancer is at stage T3 based on physical exam or MRI results.My prostate cancer has spread to my lymph nodes or other parts of my body.My prostate cancer is either low grade with more than 2 biopsy cores involved or is moderate grade.I am 18 years old or older.I had a prostate biopsy within the last 9 months.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care (no pre-treatment genomics testing)
- Group 2: Standard of care + pre-treatment genomics testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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