What side effects are associated with this type of intervention?

Common treatments for prostate cancer, including androgen deprivation therapy (ADT), radiation therapy, and chemotherapy, have several known side effects. ADT can lead to hot flashes, reduced libido, fatigue, osteoporosis, and metabolic changes. Radiation therapy may cause urinary symptoms, bowel issues, and erectile dysfunction. Chemotherapy, often used for advanced cases, can result in nausea, hair loss, fatigue, and increased risk of infections. These side effects vary in intensity and duration among patients.

What prior FDA approvals exist?

The FDA has approved several treatments for prostate cancer, including androgen receptor inhibitors like enzalutamide and abiraterone acetate, which are used in metastatic castration-resistant prostate cancer (mCRPC). Additionally, gene expression classifiers such as the Oncotype DX Genomic Prostate Score (GPS) and the Decipher Genomic Classifier (GC) have shown utility in prognostication and guiding treatment decisions, although they are not specifically FDA-approved for this purpose. These classifiers analyze gene expression levels to help stratify patients and inform treatment strategies.

What other types of research exist?

Promising novel alternatives to Gene Expression Classifier for prostate cancer patients include: 1) Urinary-based protein biomarkers identified through advanced multiplex immunoassays and MS-based targeted approaches, which have shown significant promise in initial studies. 2) Immunotherapy options such as PD-1 pathway inhibitors (e.g., pembrolizumab and dostarlimab) for patients with specific genetic markers like dMMR or high TMB. 3) Genomic testing to identify candidates for immune checkpoint inhibitors, which is crucial for determining appropriate treatment plans. These alternatives offer non-invasive and targeted approaches that could enhance treatment decisions in 2024.

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Gene Expression Classifier

Genetic Testing for Prostate Cancer

N/A

Recruiting

Led By Daniel Spratt, 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

Must not have

Prior prostate gene expression classier testing

Prior prostate cancer treatment, including prostatectomy, radiation therapy, or hormone therapy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years following treatment

Awards & highlights

Summary

This trial studies how GEC testing can improve prostate cancer care by analyzing gene activity to better predict cancer aggressiveness. It targets prostate cancer patients to help make more informed treatment decisions.

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.

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.

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 below

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My prostate cancer is either low grade with more than 2 biopsy cores involved or is moderate grade.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had gene testing for prostate cancer.

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I have had treatment for prostate cancer before.

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My cancer is at stage T3 based on physical exam or MRI results.

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My prostate cancer has spread to my lymph nodes or other parts of my body.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years following treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

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 more

Trial 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.

0 / 6Eligibility criteria met

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.