Using genomic testing to improve outcomes in men with early-stage prostate cancer

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

This study is testing if adding genomic testing to standard care can help men with early-stage prostate cancer make better treatment decisions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 900 (estimated)
• Ages: 18 Years and up
• Sex: Male
• Sponsor: University of Michigan Rogel Cancer Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 8 sites (Ann Arbor, Michigan and 7 other locations)
• Trial ID: NCT04396808 on ClinicalTrials.gov

What this trial studies

This study evaluates the clinical impact of Gene Expression Classifier (GEC) testing in men with newly diagnosed favorable risk prostate cancer. Participants will be randomized into two groups: one receiving standard care based on the askMUSIC score, and the other receiving both the askMUSIC and GEC scores. The GEC scores will be derived from biopsies analyzed using Decipher, Prolaris, or Oncotype Dx Genomic Prostate Score. The goal is to enhance decision-making regarding management strategies for prostate cancer patients.

Who should consider this trial

Good fit: Ideal candidates are men aged 18 and older with newly diagnosed favorable risk prostate cancer who have undergone a diagnostic biopsy within the last 9 months.

Not a fit: Patients with advanced prostate cancer, prior treatments, or those with certain clinical evidence of disease progression may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized treatment plans for men with prostate cancer, potentially improving patient outcomes.

How similar studies have performed: Other studies utilizing genomic classifiers in prostate cancer have shown promising results, indicating potential for this approach.

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

Where this trial is running

Ann Arbor, Michigan and 7 other locations

• University of Michigan Rogel Cancer Center — Ann Arbor, Michigan, United States (Recruiting)
• Henry Ford Health System — Detroit, Michigan, United States (Recruiting)
• Sherwood Medical Center — Detroit, Michigan, United States (Recruiting)
• Spectrum Health Medical Group — Grand Rapids, Michigan, United States (Recruiting)
• Western Michigan Urological Associates — Holland, Michigan, United States (Recruiting)
• Montefiore Medical Center — Bronx, New York, United States (Recruiting)
• University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)
• University of Pennsylvania Perelman School of Medicine — Philadelphia, Pennsylvania, United States (Recruiting)

Study contacts

• Principal investigator: Todd Morgan, M.D. — University of Michigan
• Study coordinator: G-Major Study

Conditions Prostate Cancer; Biomarkers; Active surveillance; Gene Expression Classifier