Genetic Testing for Prostate Cancer

Recruiting at 7 trial locations

Overseen By G-Major Study

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University of Michigan Rogel Cancer Center

Disqualifiers: T3 disease, Metastatic cancer, Prior treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

900 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Decipher and other genomic tests for prostate cancer?

Research shows that genomic tests like Decipher, Oncotype DX, and Prolaris can help predict outcomes and guide treatment for prostate cancer. These tests have been validated to assess the risk of cancer progression and recurrence, helping doctors make more informed decisions about patient care. ^{1 2 3 4 5}

Is genetic testing for prostate cancer safe for humans?

The genetic tests like Decipher, Oncotype DX, and Prolaris have been used to guide treatment and predict outcomes in prostate cancer, but the available research does not specifically mention any safety concerns for humans. ^{1 2 4 6 7}

How is the treatment using genetic testing for prostate cancer different from other treatments?

This treatment uses genetic tests like Decipher, Oncotype DX Genomic Prostate Score, and Prolaris to assess the aggressiveness of prostate cancer, helping to personalize treatment plans. Unlike standard treatments, these tests analyze specific genes in the cancer to predict outcomes and guide decisions on whether to pursue active surveillance or more aggressive therapies. ^{2 4 5 8 9}

Research Team

Todd Morgan, M.D.

Principal Investigator

University of Michigan

Daniel Spratt, M.D.

Principal Investigator

University of Michigan

Eligibility Criteria

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.

Inclusion Criteria

I can understand and am willing to sign the consent form, or I have someone who can legally do it for me.

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.

Exclusion Criteria

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Patients are randomized to either a control arm or an intervention arm. In the control arm, the provider reviews the askMUSIC score with the patient. In the intervention arm, the provider reviews both the askMUSIC and GEC scores with the patient.

4-8 weeks

Follow-up

Long-term follow-up will be tracked through the Michigan Urological Surgery Improvement Collaborative (MUSIC) registry.

Up to 5 years

Treatment Details

Interventions

• Decipher
• Oncotype Dx Genomic Prostate Score (GPS)
• Prolaris
• Standard of care (askMUSIC score)

Trial Overview 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.

Participant Groups

Group I: Standard of care (no pre-treatment genomics testing) Active Control 1 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 testing Active Control 4 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.

Decipher is already approved in United States, European Union for the following indications:

Approved in United States as Decipher Prostate Genomic Classifier for:

• Risk stratification of patients with localized prostate cancer

Approved in European Union as Decipher Prostate Genomic Classifier for:

• Risk stratification of patients with localized prostate cancer

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+

MDx Health

Industry Sponsor

Trials

5

Recruited

4,300+

Veracyte, Inc.

Industry Sponsor

Trials

5

Recruited

1,004,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Myrexis Inc.

Industry Sponsor

Trials

17

Recruited

4,800+

Findings from Research

A study of 22 patients who underwent at least two genomic tests for localized prostate cancer revealed significant differences in prognostic outcomes among the tests OncotypeDx, Prolaris, and Decipher, indicating that they may not be interchangeable.

The agreement between the genomic tests and treatment recommendations from the National Comprehensive Cancer Network (NCCN) was also variable, with Prolaris showing 75% agreement and Decipher only 60%, suggesting that clinicians should be cautious when interpreting results from these tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prostate cancer genomics: comparing results from three molecular assays. Alam, S., Tortora, J., Staff, I., et al.[2020]

In a study of 160 patients with grade group 2-4 prostate cancer who underwent radical prostatectomy, gene expression analysis using commercial panels (Decipher, Oncotype DX, Prolaris, and MSK-IMPACT) was effective in predicting metastasis-free survival and prostate cancer-specific death, outperforming traditional clinical parameters.

Among the gene panels, Decipher, MSK-IMPACT, and Prolaris showed similar predictive capabilities, while Oncotype DX had the lowest performance for metastasis prediction and the highest number needed to diagnose, indicating variability in the effectiveness of these gene panels for clinical decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcript analysis of commercial prostate cancer risk stratification panels in hard-to-predict grade group 2-4 prostate cancers. Lehto, TK., Stürenberg, C., Malén, A., et al.[2022]

The Decipher Prostate Genomic Classifier (GC) test significantly influences treatment decisions for prostate cancer, with patients receiving the test being more likely to choose active surveillance or watchful waiting, especially those classified as low-risk (41% compared to 11% for high-risk).

Higher GC scores are linked to a greater likelihood of adverse pathological findings during surgery and increased use of postoperative radiotherapy, indicating that the GC can help identify patients who may need more aggressive treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the Decipher genomic classifier among men with prostate cancer in the United States. Zaorsky, NG., Proudfoot, JA., Jia, AY., et al.[2023]

The 17-gene Oncotype DX® Genomic Prostate Score™ assay is a significant independent predictor of adverse pathology findings in men with very low, low, or intermediate risk prostate cancer, even when diagnosed through advanced imaging techniques like multiparametric MRI.

In a study of 134 men, the prostate score assay remained a strong predictor of adverse pathology after adjusting for other clinical factors, suggesting it can enhance risk stratification and treatment decisions for prostate cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 17-Gene Genomic Prostate Score Assay Provides Independent Information on Adverse Pathology in the Setting of Combined Multiparametric Magnetic Resonance Imaging Fusion Targeted and Systematic Prostate Biopsy. Salmasi, A., Said, J., Shindel, AW., et al.[2019]

The Oncotype DX Genomic Prostate Score (GPS) assay is a strong predictor of biochemical recurrence in prostate cancer patients with intermediate and higher risk, based on a study of 141 patients who underwent radical prostatectomy.

In this study, higher GPS scores were significantly associated with shorter time to biochemical recurrence, indicating that the assay can help guide treatment decisions for patients at risk of recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The 17-gene Genomic Prostate Score assay as a predictor of biochemical recurrence in men with intermediate and high-risk prostate cancer. Helfand, BT., Paterakos, M., Wang, CH., et al.[2022]

The Decipher Prostate Cancer Test, which analyzes 22 RNA markers, has shown high accuracy in predicting clinical metastasis (0.75-0.83) and cancer-specific mortality (0.78), outperforming traditional clinicopathologic characteristics.

This test can guide treatment decisions, such as the timing of postoperative radiotherapy, and serves as an independent predictor of clinical metastasis in patients with biochemical recurrence after surgery, highlighting its potential in personalized prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary Role of the Decipher® Test in Prostate Cancer Management: Current Practice and Future Perspectives. Dalela, D., Löppenberg, B., Sood, A., et al.[2020]

Emerging tests like the prostate health index and 4-kallikrein score enhance prostate cancer screening alongside traditional PSA testing, potentially leading to better early detection.

Tests such as Decipher and Prolaris can predict the risk of cancer recurrence and help determine the need for additional treatments after surgery, improving personalized care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Precisely Can Prostate Cancer Be Managed? Zhuang, L., Johnson, MT.[2020]

The 17-gene Oncotype DX Genomic Prostate Score (GPS) test was evaluated in a study of 432 men with low-risk prostate cancer under active surveillance, but it did not significantly improve the prediction of adverse pathology (AP) compared to traditional clinical variables like Gleason Grade Group (GG) and prostate-specific antigen density (PSAD).

While GPS was associated with AP when adjusted for GG, this association became non-significant when PSAD was also considered, indicating that GPS may not provide additional predictive value in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

17-Gene Genomic Prostate Score Test Results in the Canary Prostate Active Surveillance Study (PASS) Cohort. Lin, DW., Zheng, Y., McKenney, JK., et al.[2022]

Incorporating the Oncotype DX Genomic Prostate Score in treatment decisions led to a 22% relative increase in the recommendation for active surveillance among men with newly diagnosed low-risk prostate cancer, rising from 50% to 61%.

The use of active surveillance also increased significantly by 56%, from 43% to 67%, indicating that the Genomic Prostate Score helps physicians make more informed treatment choices aligned with the assessed risk of disease aggressiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of the Oncotype DX® Prostate Cancer Assay in Clinical Practice for Treatment Selection in Men Newly Diagnosed with Prostate Cancer: A Retrospective Chart Review Analysis. Dall'Era, MA., Maddala, T., Polychronopoulos, L., et al.[2023]

References

1. Canada pubmed.ncbi.nlm.nih.gov

Prostate cancer genomics: comparing results from three molecular assays. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Transcript analysis of commercial prostate cancer risk stratification panels in hard-to-predict grade group 2-4 prostate cancers. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Use of the Decipher genomic classifier among men with prostate cancer in the United States. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

A 17-Gene Genomic Prostate Score Assay Provides Independent Information on Adverse Pathology in the Setting of Combined Multiparametric Magnetic Resonance Imaging Fusion Targeted and Systematic Prostate Biopsy. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

The 17-gene Genomic Prostate Score assay as a predictor of biochemical recurrence in men with intermediate and high-risk prostate cancer. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Contemporary Role of the Decipher® Test in Prostate Cancer Management: Current Practice and Future Perspectives. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

How Precisely Can Prostate Cancer Be Managed? [2020]

8. United States pubmed.ncbi.nlm.nih.gov

17-Gene Genomic Prostate Score Test Results in the Canary Prostate Active Surveillance Study (PASS) Cohort. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Utility of the Oncotype DX® Prostate Cancer Assay in Clinical Practice for Treatment Selection in Men Newly Diagnosed with Prostate Cancer: A Retrospective Chart Review Analysis. [2023]