Genetic Testing for Prostate Cancer
Recruiting in Palo Alto (17 mi)
+7 other locations
Overseen byTodd Morgan, M.D.
Age: 18+
Sex: Male
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Michigan Rogel Cancer Center
Disqualifiers: T3 disease, Metastatic cancer, Prior treatment, others
No Placebo Group
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.
12345Is 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.
12467How 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.
24589Eligibility 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.
+3 more
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.
+1 more
Trial 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
Participant Groups
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.
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Montefiore Medical CenterBronx, NY
University of North CarolinaChapel Hill, NC
Spectrum Health Medical GroupGrand Rapids, MI
Sherwood Medical CenterDetroit, MI
More Trial Locations
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Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer CenterLead Sponsor
MDx HealthIndustry Sponsor
Veracyte, Inc.Industry Sponsor
National Institutes of Health (NIH)Collaborator
Myrexis Inc.Industry Sponsor
References
Prostate cancer genomics: comparing results from three molecular assays. [2020]OncotypeDx, Prolaris, and Decipher have each been validated to predict outcomes and guide treatment for patients with clinically localized prostate cancer, but they have yet to be compared to one another. Here we assess the correspondence between the results of each.
Transcript analysis of commercial prostate cancer risk stratification panels in hard-to-predict grade group 2-4 prostate cancers. [2022]Improved prognostication is needed to minimize overtreatment in grade group (GG) 2-4 prostate cancer. Our aim was to determine, at messenger RNA (mRNA) level, the performance of the genes in the commercial panels Decipher, Oncotype DX, Prolaris, and mutational panel MSK-IMPACT to predict metastasis-free and prostate cancer-specific death (PCSD) in patients with GG 2-4 prostate cancer at radical prostatectomy.
Use of the Decipher genomic classifier among men with prostate cancer in the United States. [2023]Management of localized or recurrent prostate cancer since the 1990s has been based on risk stratification using clinicopathological variables, including Gleason score, T stage (based on digital rectal exam), and prostate-specific antigen (PSA). 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 database of men with prostate cancer.
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]Multiparametric magnetic resonance imaging and biopsy based molecular tests such as the 17-gene Oncotype DX® Genomic Prostate Score™ assay are increasingly performed to improve risk stratification in men with clinically localized prostate cancer. The prostate score assay was previously shown to be a significant independent predictor of adverse pathology findings at radical prostatectomy in men diagnosed by systematic biopsies only. Therefore, we investigated the ability of the prostate score assay to predict adverse pathology findings in the setting of magnetic resonance imaging guided prostate biopsy.
The 17-gene Genomic Prostate Score assay as a predictor of biochemical recurrence in men with intermediate and high-risk prostate cancer. [2022]The validated 17-gene Oncotype DX Genomic Prostate Score® (GPS™) assay risk-stratifies prostate-cancer patients with localized disease. The assay has primarily been utilized in lower risk patients deciding between active surveillance versus definitive therapy. In this retrospective cohort study, we analyze the association of the GPS result with time to biochemical recurrence post-prostatectomy in patients with National Comprehensive Cancer Network® (NCCN) intermediate and higher risk prostate cancer. The 141 patients included in the study were from the NorthShore University HealthSystem diagnosed 2014-2019 with NCCN intermediate (n = 109) or higher risk (n = 32) prostate cancer, treated with radical prostatectomy 2015-2019. The association of GPS result with time to biochemical recurrence was evaluated using univariable and multivariable Cox proportional hazards models in 120 patients with unfavorable intermediate or higher risk. Median (interquartile range) follow-up time was 28 (20 to 38) months. The GPS result was significantly associated with time to biochemical recurrence as both a continuous and dichotomous variable in univariable (hazard ratio [HR] per 20 GPS units 2.36, 95% CI 1.45-3.80, p
Contemporary Role of the Decipher® Test in Prostate Cancer Management: Current Practice and Future Perspectives. [2020]We performed a systematic literature search to identify original articles and editorials about the Decipher(®) Prostate Cancer Test (GenomeDx Biosciences, San Diego, CA) to provide an overview of the current literature and its present role in urologic clinical practice. The Decipher test, which uses the expression of 22 selected RNA markers (from a total of over 1.4 million), showed a very high discrimination in predicting clinical metastasis (0.75-0.83) and cancer-specific mortality (0.78) in external validation studies, outperforming all routinely available clinicopathologic characteristics. Further, the timing of postoperative radiotherapy (adjuvant vs salvage) may be guided based on Decipher scores. The Decipher test was also the only independent predictor of clinical metastasis in patients with biochemical recurrence after surgery. The Decipher Genomic Resource Information Database (GRID) is a novel research tool that captures 1.4 million marker expressions per patient and may facilitate precision-guided, individualized care to patients with prostate cancer. In this era of precision medicine, Decipher, along with the Decipher GRID platform, is a promising genomic tool that may aid in managing prostate cancer patients throughout the continuum of care and delivering appropriate treatment at an individualized level.
How Precisely Can Prostate Cancer Be Managed? [2020]Progress has been made in applying genetic information to disease management in the postgenomic era, and precision medicine is emerging in prostate cancer management. The prostate health index, the 4-kallikrein (4K) score, and the PCA3, TMPRSS2- ERG, and Prostarix tests have potential for refining prostate cancer screening in conjunction with traditional prostate-specific antigen testing. The Confirm MDx and PCA3 tests have shown promise in identifying men who need be rebiopsied after a primary negative biopsy. Oncotype DX, Prolaris, the biopsy-based Decipher prostate cancer test, and ProMark may improve predictive risk stratification in addition to the traditional Gleason score and tumor stage. Decipher and Prolaris may predict biochemical recurrence and metastasis after radical prostatectomy and possibly help identify patients who need adjuvant therapy. Androgen receptor splice variant 7 appears effective in guiding the selection of second hormonal manipulation with abiraterone or enzalutamide versus chemotherapy when treating metastatic castration-resistant prostate cancer.
17-Gene Genomic Prostate Score Test Results in the Canary Prostate Active Surveillance Study (PASS) Cohort. [2022]Label="PURPOSE">The 17-gene Oncotype DX Genomic Prostate Score (GPS) test predicts adverse pathology (AP) in patients with low-risk prostate cancer treated with immediate surgery. We evaluated the GPS test as a predictor of outcomes in a multicenter active surveillance cohort.
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]The 17-gene Oncotype DX® prostate cancer assay (Genomic Health Inc., Redwood City, California) is a validated, biopsy based gene expression assay that reports the Genomic Prostate Score. Combined with clinical risk features, Genomic Prostate Score provides an individualized estimation of disease aggressiveness at diagnosis. With this retrospective chart review we assessed the impact of incorporating the Oncotype DX Genomic Prostate Score on treatment recommendations and decisions for men with newly diagnosed low risk prostate cancer in community urology practices.