UPCC 01823 Genomics in Michigan to AdJust Outcomes in prostate canceR (G-MAJOR): A randomized controlled multi-center study for men with newly diagnosed favorable risk prostate cancer
Studying Gene Expression Classifier Testing in Prostate Cancer
Brief description of study
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 of study
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.
FEB2026- Amendment was approved to decrease accrual from 900 to 800 as the study had been going on for longer than anticipated due to decreasing enrollment.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Prostate Cancer
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Age: 18 years or above
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Gender: Male
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
The purpose of this study is to investigate the impact of Gene Expression Classifier (GEC) testing on prostate cancer care. This study involves men with newly diagnosed favorable risk prostate cancer. Participants will be assigned to one of two study arms: the intervention arm or the control arm. The control arm will review a risk score from the askMUSIC scoring system, which considers factors like prostate-specific antigen (PSA) levels and Gleason scores. The intervention arm will review both the askMUSIC score and a GEC score, which helps assess the cancer's behavior.
Participants will not undergo any additional biopsies for this study. Instead, biopsies taken as part of standard care will be used. The GEC scores will be derived from tests like Decipher, Prolaris, or Oncotype Dx Genomic Prostate Score. After reviewing scores, patients and their doctors will decide on a management strategy. Long-term follow-up will be conducted through a registry to track outcomes.
- Who can participate: Men aged 18 years or older with newly diagnosed favorable risk prostate cancer can participate. They must have undergone a prostate biopsy in the past 9 months and have prostate biopsy tissue available for processing. Key eligibility includes a PSA level under 20 ng/ml and specific cancer grade group criteria.
- Study details: Participants will be randomly assigned to one of two arms. In the control arm, only the askMUSIC score will be reviewed, while the intervention arm will review both the askMUSIC and GEC scores. No additional biopsies are required as part of this study.
Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.
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