Genetic Testing for Prostate Cancer

Recruiting at 8 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how genetic tests can improve decision-making in prostate cancer treatment. Researchers compare standard care with and without gene tests such as Decipher (a genomic classifier), Oncotype Dx Genomic Prostate Score (GPS), and Prolaris in assessing prostate cancer. Men who have had a prostate biopsy in the last nine months and exhibit specific cancer characteristics may be suitable candidates. Participants will help determine if genetic testing can better guide cancer management. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future prostate cancer treatment strategies.

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 prior data suggests that these genomic tests are safe for prostate cancer patients?

Research has shown that the genomic tests Decipher, Oncotype Dx Genomic Prostate Score (GPS), and Prolaris are safe for patients. These tests help predict prostate cancer outcomes and assist doctors in making better treatment decisions.

Decipher has undergone thorough testing and provides doctors with crucial information for managing prostate cancer. It helps identify patients who might need more aggressive treatment and those who might be suitable for close monitoring without immediate intervention.

Oncotype Dx GPS predicts the likelihood of encountering more serious issues during prostate surgery. It serves as a strong, independent tool that aids doctors and patients in making informed care decisions.

The Prolaris test is also valuable for predicting the aggressiveness of prostate cancer. It assists doctors in deciding whether to initiate treatment immediately or to monitor the cancer. Studies have shown it provides reliable information for different patient groups.

Research has not mentioned specific side effects for these genomic tests, suggesting they are safe to use. However, discussing any concerns with a healthcare provider before joining a clinical trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the genetic testing approach for prostate cancer because it adds a new layer of precision to treatment decisions. Standard care often relies on general assessments like the askMUSIC score, but genetic tests such as Decipher, Oncotype Dx Genomic Prostate Score (GPS), and Prolaris offer insights into the cancer's genetic makeup. This approach allows doctors to tailor treatment plans based on each patient’s unique genetic profile, potentially improving outcomes and minimizing unnecessary treatments. By integrating genomics into standard care, there's hope for more personalized and effective management of prostate cancer.

What evidence suggests that this trial's genomic tests could be effective for prostate cancer?

Research shows that genomic tests like Decipher, Oncotype Dx Genomic Prostate Score (GPS), and Prolaris help doctors make better treatment choices for prostate cancer. In this trial, one group of participants will receive standard care without pre-treatment genomics testing, while another group will receive standard care plus pre-treatment genomics testing using one of these tests. The Decipher test predicts tumor aggressiveness and helps determine if active surveillance (watchful waiting) is a suitable option. Studies have shown that using the Oncotype Dx GPS test leads to more patients choosing active surveillance instead of immediate treatment. The Prolaris test predicts outcomes and can change treatment decisions in about 65% of cases. All these tests aim to provide doctors with more information to guide treatment decisions effectively. ^{1 3 4 6 7}

Who Is on the Research Team?

Todd Morgan, M.D.

Principal Investigator

University of Michigan

Daniel Spratt, M.D.

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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.

PSA <20 ng/ml

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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 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&#174; 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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2588931124001834

Association Between the Decipher Genomic Classifier and ... Among biopsy-tested participants, metastasis rates at 2 yr were 0.5% (95% CI 0.4–0.6%) in those with Decipher low-risk scores, 0.7% (0.4–1.0%) in those with ...

2. decipherbio.com decipherbio.com/decipher-prostate/physicians/decipher-prostate-overview/

The Most Validated Genomic Test for Prostate Cancer Decipher Prostate by Veracyte is the most validated prostate cancer genomic test offering physicians actionable insights for decisions.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8883188/

Association Between a 22-feature Genomic Classifier and ... We found that the Decipher genomic classifier score was associated with subsequent biopsy upgrading among patients enrolled on active surveillance for low-risk ...

4. veracyte.com veracyte.com/decipher-prostate/

Decipher Prostate - Exceptional Prognostic Testing The Decipher Prostate test helps match treatment timing and intensity with the tumor's aggressiveness for patients with prostate cancer. Patients with low risk ...

5. eajm.org eajm.org/Content/files/sayilar/234/EAJM_20250828_nlm_new_indd%5B45%5D.pdf

The Clinical Impact of the Decipher Genomic Classifier in ... The Decipher GC has demonstrated clinical utility across risk groups, helping to distinguish candidates for active surveillance in low-risk ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10505256/

Use of the Decipher genomic classifier among men with ... In this study a novel prognostic test, the Decipher Prostate Genomic Classifier (GC), was used to stratify risk of prostate cancer progression in a US national ...

7. urotoday.com urotoday.com/center-of-excellence/decipher-genomic-classifier-in-prostate-cancer.html

Decipher® Genomic Classifier in Prostate Cancer The Decipher genomic classifier (GC) has shown to independently prognosticate outcomes in prostate cancer. The objective of this study was to validate the GC in ...