Wednesday, December 7, 2022

Decipher Genomic Testing For Prostate Cancer

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Use In Everyday Medical Care

Decipher, SelectMDx, and 4K Score in Active Surveillance & Intermediate Prostate Cancer | PCRI

Current guidelines from leading medical organizations don’t recommend routine use of the Decipher test. But the new study results should prompt these organizations to reconsider such guidelines on the basis of the strength of the evidence, Dr. McGuire wrote. The tests use in everyday medical practice should become commonplace, he added.

The question of whether hormone therapy should be added to radiation for patients with rising PSA after surgery is a question I see all the time in my practice, Dr. Feng said. My patients very much want to know if hormone therapy has a good chance of benefiting them. Tests like this are important because, if we can provide more information to patients and physicians, they can make better choices together.

There are still many questions about how to use the Decipher test in different groups of patients with prostate cancer, Dr. McGuire wrote. About 20 ongoing clinical studies are looking to provide some answers.

One area that needs further study is how well the test works in people of color, Dr. Feng noted. Recent evidence has shown that genetic-based tests can be less useful for people of color if there was a lack of diversity among participants in the studies that were done to develop and validate the test.

Genetic Testing For Prostate Cancer

Thanks to research funded by the Prostate Cancer Foundation, we now know that some prostate cancers are caused by changes in your genes. 5%-10% of all cancers are hereditary, meaning that certain cancer-causing gene changes are passed down from mothers and fathers to sons and daughters. Another 10%-20% of all cancers are familial, meaning that a type of cancer occurs in multiple family members, but is not directly related to specific gene changes.

Genes are made of DNA, which is the master instruction manual that tells every cell in the body which proteins to make essentially, the information that each cell needs to do its job. A genetic mutation is a change in part of the normal DNA that makes up a gene. Some mutations are hereditary, meaning that they are passed down from one family member to another. Mutations can also be caused after birth by various lifestyle and environmental factors, such as smoking or the UV rays from the sun.

Genetic mutations can be passed down from father to son, father to daughter, mother to son, or mother to daughter. We now know that some of the same gene mutations that cause prostate cancer can also cause other forms of cancer and vice versa. Therefore, it can be important to consider genetic testing if you have a history of cancer in your family, even if its not prostate cancer. This is referred to as genetic testing for an inherited mutation or genetic testing for inherited cancer risk.

Oncotypedx Genomic Prostate Score

In summary, Oncotype DX GPS helps assess underlying tumor biology on prostate biopsy tissue, and has a significant impact in the decision-making between initial treatment or surveillance options for patients with newly-diagnosed prostate cancer. Whether it also has a significant benefit during the course of surveillance remains to be established.

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Molecular And Genomic Testing For Prostate Cancer

Urology Austin offers additional molecular and genomic testing for our patients. The inclusion of molecular testing gives additional independent information, so that the patient and their doctor can confidently choose an individualized treatment plan that is appropriate.

There are several molecular and genomic tests available for different stages of treatment that include pre-biopsy, positive prostate biopsy, post-surgery and during treatment of advanced prostate cancer. Ordering a specific test depends on different factors including the patients specific clinical presentation, history and the volume and quality of the tumor tissue remaining after a biopsy.

Prostate Cancer Gene Expression Testing At Ucsf

Decipher Prostate Cancer Test

A major challenge in tailoring prostate cancer care is identifying men who require immediate or aggressive treatment and those who possess prostate cancers that can safely be surveyed. Several prediction tools have been developed and tested at UCSF including the CAPRA, and CAPRA-S scores. Recently, several commercially available genetic tests taken from an individuals prostate cancer tissue have become available that may assist urologists and patients in clinical decision making. UCSF Department of Urology has collaborated with Genomic Health, Inc and Myriad Genetics to evaluate genomic biomarkers, as well as conducted several independent studies of these markers.

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Prostate Biopsy Based Genetic Testing

There are definite advantages to non-invasive genetic testing with regards to patient comfort and inconvenience, however, tissue samples are still required for more detailed genomic analysis at present time . The prostate biopsy based tests require a small section of diagnostic material to be sent to a central laboratory for analysis, relying upon the services of local pathologists to select an appropriate sample of tissue. The raw data generated from genetic testing is then interpreted in the context of the validation cohorts for each specific product and then reported to the physician and patient in an easy to read manner that typically provides some type of score with a corresponding percentage of patients who developed a specific outcome .

Table 2

Biomarker And Genomic Tests In Prostate Cancer

Its important to talk to your doctor to find out if you are a candidate for a genomic test. There are several tests available today. Current tests include:

  • FoundationOne Liquid CDX:
  • FoundationOne Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw. It is the only FDA-approved blood test to analyze over 300 genesmaking it the most comprehensive FDA-approved liquid biopsy on the market. With more targeted therapy options for prostate cancer now available, this comprehensive genomic profiling can help guide treatment strategies and help predict how patients will benefit from those treatments.
  • This test looks at the activity of certain genes in the prostate tumor and assigns a personalized result, called the Genomic Prostate Score, to each case. This number predicts the chance that the disease will be more aggressive and spread to other parts of the body if left untreated. This is used after a confirmed prostate cancer diagnosis of low-risk disease and uses biopsy tissue to predict the likelihood of future growth and spread. It is helpful for those considering active surveillance.
  • This test looks at a sequence of certain genes and provides a personalized genetic panel to determine aggressiveness. This is used after a confirmed prostate cancer diagnosis and uses biopsy tissue to predict the likelihood of future growth and spread. It is helpful for those considering active surveillance.
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    Why Genetic Testing For Prostate Cancer

    Studies have revealed several inheritable genes which are associated with prostate cancer. Getting whole-genome sequencing through a company like Nebula Genomics can help you discover how high your risk of developing prostate cancer is. Some of the gene mutations associated with prostate cancer are on the MLPH, BRCA1 and BRCA2, CHEK2, and TP53 genes.

    About 10% of men are at risk of being diagnosed with prostate cancer. However, men with family members who have prostate cancer are 20% likely to develop it. If the family member is in the immediate family, such as a father or a brother, the risk increases to about 50%. Genes that are suspected to be linked with prostate cancer have a 50% chance of being passed on to the next generation.

    Genetic testing for prostate cancer has other benefits aside from early diagnosis. After genome sequencing, if a person is found to carry gene variants that are associated with prostate cancer, it can help other family members decide to get tested too. Genetic counselors can help review the results of genetic testing once performed.

    Genetic testing helps you determine if your prostate cancer is hereditary or not and then helps the specialists make more informed decisions on treatment.

    Genetic research is also helping with the nearly 600 clinical trials designed to help create better treatments.

    Genomic Test Could Help Predict Aggressive Disease In Men Newly Diagnosed With Prostate Cancer

    Using Decipher Testing to Inform ADT Decisions in Intermediate Risk Prostate Cancer

    An analysis of patient data from across Michigan found scores from the Decipher Biopsy test independently aligned with outcomes.

    After a biopsy comes back positive for prostate cancer, patients and their doctors are often left with a choice between taking a watch-and-wait approach, known as active surveillance, or proceeding with surgery or radiation.

    And identifying which patients will benefit from more immediate and aggressive treatment isnt always clear.

    A new, University of Michigan-led study analyzing data from more than 850 patients across the state of Michigan, however, found a commercially available genomic test known as Decipher Biopsy may help identify patients who are at high risk of cancer progression.We have long needed better tools to reduce the uncertainty of these initial treatment decisions, said study first author Randy Vince, Jr., M.D., M.S., an oncology fellow at U-M.Veracyte, the company that makes the tests, did not sponsor the study or play a role in the analysis.

    Between February 2015 and October 2019, 855 patients participating in the state Michigan Urological Surgery Improvement Collaborative registry underwent testing with the Decipher Biopsy test after being diagnosed with prostate cancer one of the first real-world, observational studies of a commercially available genomic test designed to aid in decision-making after an initial diagnosis.

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    New Data Validate Clinical Utility Of Genomic Classifier Test To Help Guide Therapy For Men With Intermediate

    2/18/2022 3:26:54 PM

    New data validating the clinical utility of the Decipher prostate genomic classifier for guiding treatment selection in men with intermediate-risk prostate cancer was presented at the 2022 ASCO Genitourinary Cancers Symposium . Data from the randomized phase III NRG/RTOG 0126 study, confirm initial findings that the genomic test provides prognostic biomarker information that can help physicians and patients make personalized treatment decisions in the intermediate-risk setting.

    These findings represent the first high-level evidence of any genomic classifier in intermediate-risk prostate cancer and demonstrate that the Decipher 22-gene biomarker significantly improves prognostic performance across numerous clinically meaningful endpoints, said lead investigator for the study Daniel Spratt, MD, Chair of Radiation Oncology at University Hospitals Seidman Cancer Center and Professor and Chair of the Department of Radiation Oncology at Case Western Reserve University School of Medicine.

    These findings represent the first high-level evidence of any genomic classifier in intermediate-risk prostate cancer and demonstrate that the Decipher 22-gene biomarker significantly improves prognostic performance across numerous clinically meaningful endpoints. Daniel Spratt, MDTweet this quote

    Prognostic Performance Measured in Samples From NRG/RTOG 0126

    Informing Treatment in Asian Men With Prostate Cancer

    What Is Prostate Cancer

    Prostate cancer is a type of cancer that affects the prostate, the walnut sized gland in a biological male below the bladder, where the seminal fluid is produced. This fluid is responsible for providing food to and transporting sperm. Genetic testing for prostate cancer can play an important role in assessing risk and creating a treatment plan after diagnosis.

    Prostate cancer is one of the most common types of cancer. According to the CDC, out of every 100 men in the United States, about 13 will get prostate cancer during their lifetime, and about 2 to 3 men will die from the disease. The greatest risk factor of developing the condition is older age. African American men and those with a family history may be at an increased risk.

    The growth of prostate cancer is usually slow and is detected before it spreads beyond the prostate gland. Localized prostate cancer cases can remain benign for decades so it is possible to live with prostate cancer without realizing it. In this case, treatment may involve watching for changes.

    However, some subtypes may grow fast and spread aggressively. Men with metastatic prostate cancer may require more involved therapies immediately to treat this type of cancer.

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    Available Molecular And Genomic Tests

    The following is a brief outline of the available molecular and genomic tests your physician may order. We recommend that you learn more about these tests by visiting their company websites.

    Prolaris: a genomic test developed and marketed by Myriad Genetics, Inc. This test is indicated for patients who have been diagnosed with low to intermediate or high-risk prostate cancer. This risk assessment tool can help predict how aggressive the tumor may be or become in the future. This information guides the physician and patient with treatment decisions. The report provides information on pursuing active surveillance or if specific therapies like radiation or ADT are necessary. to learn more about Prolaris.

    Oncotype Dx: a genomic test developed and marketed by Genomic Health. Similar to other risk stratification tests, Oncotype is indicated for newly diagnosed patients with low to intermediate risk prostate cancer. Predicting the aggressiveness of the tumor can help a physician and patient decide the appropriate course of treatment. to learn more about Oncotype Dx.

    Oncotype Dx AR-V7 Nucleus Detect: This blood test is specifically designed for metastatic castrate-resistant prostate cancer and can test for the AR-V7 protein, which is a predictive biomarker. The results of the test allow the physician and patient to decide if switching to another oral oncolytic is appropriate or to proceed with chemotherapy. to learn more about Oncotype Dx AR-V7 Nucleus Detect.

    Myriad Genetics Genetic Testing For Prostate Cancer

    Hormone Therapy for Prostate Cancer? A Genetic Test Could Help Decide ...

    This genetic testing company offers genetic testing for prostate cancer. Myriad Genetics has been selling genetic testing services for over 25 years and is constantly making efforts to bring the significance of genetics in diseases to the attention of both patients and medical practitioners. Myriad Genetics has carried out various studies to link genetics with various diseases to improve the process of diagnosis and treatment of diseases.

    Myriads gene testing procedure for prostate cancer is called Prolaris. Prolaris costs $2400 per test. The company notes that most insurance companies will cover the entire cost of the test. For those with out-of-pocket costs, the price is usually less than $60.

    Prolaris offers both tumor testing for confirmed tumors and genetic testing to identify if you have inherited a genetic mutation that increases your risk of developing cancer.

    Prolaris, in combination with other screening tests, can be used to assess the aggressiveness of prostate cancer and the chances it will spread to other parts of the body. This product is designed for men with untreated cancer. It can also be used to aid in treatment decisions, such as choosing active surveillance or a multi-model aggressive treatment.

    The genetic testing portion of Prolaris is for men with prostate cancer, treated or untreated. It assesses whether an inherited mutation may have caused your cancer. It can impact early treatment decision making and qualify individuals for certain treatments.

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    Biomarker Testing And Precision Medicine

    Biomarker testing and precision medicine are somewhat newer terms in the cancer space. Biomarker testing looks for genes, proteins, and tumor markers that tell us more about your specific cancer. Biomarkers can help doctors diagnose cancer and monitor cancer, and can also affect how some treatments will work for you.

    Prostate specific antigen is the most widely used prostate cancer biomarker but new and emerging blood, urine, and tissue biomarkers are also now available. The prostate health index, or PHI, as well as the 4KScore, are newer biomarker tests that help in diagnosing prostate cancer and identifying more aggressive disease, which also may reduce the number of prostate biopsies performed in men with low PSA levels.

    Biomarker testing, also called comprehensive genomic profiling , tumor testing, molecular profiling, tumor subtyping, or somatic testing, uses a single test to examine a persons genes. The test looks for mutations in genes that are relevant in cancer and that may drive cancer growth. Some of these biomarkers tell your doctors how aggressive your prostate cancer might be. Biomarker testing may help you and your doctor better understand your particular cancer and choose the best treatment option for you.

    Biomarker testing is not the same as genetic testing. Genetic testing tells you which genes have been passed on to you by your parents, or inherited.

    Genomic Decipher Score Predicts Prostate Cancer Metastasis Mortality

    The Decipher prostate cancer gene-expression classifier can predict patients risk of metastasis and prostate cancer-specific mortality using biopsy specimens prior to radical prostatectomy or radiotherapy plus androgen deprivation.

    The Decipher prostate cancer gene-expression classifier can predict patients risk of metastasis and prostate cancer-specific mortality using biopsy specimens prior to radical prostatectomy or radiotherapy plus androgen deprivation, according to a mixed-cohort study presented at the 2017 American Society of Clinical Oncology Genitourinary Cancers Symposium, held February 1618 in Orlando, Florida.

    It provided significant prognostic information beyond clinical variables alone, said Paul L. Nguyen, MD, vice chair for clinical research at Brigham and Womens Hospital and the Dana-Farber Cancer Institute in Boston. Those 20% of patients with genomic high risk actually had a very high 23.4% metastasis and a very high risk, almost 10%, of dying from prostate cancer. For these patients we have to think, could there be a role for treatment intensification or enrolling these patients in a clinical trial?

    Previous studies have evaluated the use of Decipher after radical prostatectomy. The authors of the new study sought to assess the Decipher classifiers prognostic utility when used earlier, with biopsy specimens, in order to inform initial treatment decisions.

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    What Is Decipher Test For Prostate Cancer

    It looks at certain genes to predict how aggressive is the cancer and its chances of metastasis.

    A small tissue sample from the prostatectomy tissue is analyzed and the expression levels of RNA biomarkers are determined.

    Decipher test is helpful in deciding the course of treatment for men after they undergo surgery for prostate cancer. In one study recommendations to undergo radiation therapy were reduced by 50%, based on Decipher test. Other studies using Decipher test reclassified 60% of men as lower risk category from higher risk. Out of these, 98.5% of patients did not develop metastasis with 5 years of radical prostatectomy.

    The classification of the patients in high, low and average risk of developing metastasis is based on the validation in over 2,000 patients in clinical studies. The test accurately predicts the probability of metastasis after surgery. It is an independent assessment of tumor aggressiveness and this information is distinct from that provided by Gleason score or PSA.

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