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Polaris Test For Prostate Cancer

Is There Additional Information That Helps Assess Risk

Prolaris Testing in Men With Clinically Localized Prostate Cancer

In more recent years, additional information is available to help assess the potential aggressiveness of the cancer. While stage , grade and volume are the most important factors to identify risk group, genetic testing of the biopsy material is now available to identify certain genes which may suggest either an increase or decrease in the aggressive potential of the cancer cells. The additional information provided with genetic testing may help determine if a man is a suitable candidate for active surveillance, or whether he should consider undergoing intervention with either surgery or radiation. Also, prostate imaging with multiphase MRI may provide additional information that may help assess the extent of disease to assist with treatment selection.

Which Test Is Best For Me

Both Prolaris® and Decipher®are tissue-based gene expression tests that can be performed on specimen preserved after radical prostatectomy and may assist in making decisions. At present, no direct comparisons have been made between these two products. Consideration of gene expression testing should take place in careful consultation with your physician.

A Genetic Biomarker Test For Newly Diagnosed Prostate Cancer

Results from a study of a different genetic biomarker test suggest that it could one day help inform treatment decisions for men newly diagnosed with localized prostate cancer.

According to findings published February 24 in JCO Precision Oncology, a biomarker test called the Oncotype DX Genomic Prostate Score accurately predicted the long-term risk of metastasis and death from prostate cancer in men with localized disease. The test needs to be validated in larger forward-looking studies before it can be used to guide treatment, the study researchers noted.

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Prolaris Test Predicts Prostate Cancer Mortality Risk

Three new studies of Prolaris, a prognostic molecular test for risk stratification in prostate cancer, were presented at the American Urological Association Annual Meeting in Orlando, Florida.

Prolaris is a molecular diagnostic test that measures the level of RNA expression of genes involved in prostate tumor growth. This helps physicians stratify the risk of disease progression in patients with prostate cancer. Low levels of gene expression are associated with a low risk of disease progression and men in this group may be candidates for active surveillance. High levels of gene expression are associated with a higher risk of disease progression and these patients may benefit from additional therapy.

The first study followed 761 patients whose prostate cancer was diagnosed by needle biopsy and treated with conservative therapy. The primary end point was death from prostate cancer and the median follow-up time was 9.5 years. A patients risk of dying from prostate cancer doubled with each unit increase in the Prolaris score.

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The Prolaris test distinguished newly diagnosed patients who were likely to die from prostate cancer within 10 years from those with lower risk disease. The Prolaris test was a better predictor of mortality than Gleason score, prostate-specific antigen , age, clinical stage, or extent of disease.

Prostate Cancer Still No1

Genetic Testing and Prostate Cancer

According to the American Cancer Society, prostate cancer remains the most commonly diagnosed malignancy among men in the United States. The top five cancers in American men are shown here.

Prolaris is the first prognostic test to determine the aggressiveness of prostate cancer and has been studied in more than 10 clinical studies with thousandsof patients. The test measures the activity level of 46 genes and provides physicians with precise objective information that is based on the tumorsgenetic profile. Simply put, men with a low Prolaris score have a low risk of disease progression and may be candidates for active surveillance, whilethose with a high score are at higher risk and may benefit from additional therapy.

The Prolaris test already is changing the equation in the fight against prostate cancer. Any physician who has treated prostate cancer knows all too wellthe personal and financial cost of undertreating an aggressive cancer or overtreating a slow growing, indolent cancer. More work needs to be done toreduce the death toll from prostate cancer, but Medicares positive decision will help ensure that Medicare patients who need a Prolaris test will haveaccess.

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When Prostate Cancer Is Diagnosed Does It Always Need Treatment

Of all those men who are diagnosed with cancer, a subset will have an aggressive type disease that if left untreated, will progress with cancer spread beyond the prostate and which may eventually cause death from prostate cancer.

For those men who have aggressive disease, intervention with surgery or radiation addresses the prostate cancer in an effort to cure the prostate cancer or reduce its potential for subsequent spread. However, both of those treatment avenues pose potential hazards, which can include ED , or incontinence .

What Causes Prostate Cancer

According to the American Cancer Society, researchers do not know exactly what causes prostate cancer. However, they have found some risk factors and are trying to learn just how these factors may cause prostate cells to become cancer. These associations may increase the risk of developing prostate cancer:

  • Age:Most common in men ages 55-79 years
  • Ethnicity:AfricanAmericans are in the highest risk group.
  • Family history:2 to 11 times more atrisk
  • Smoking:Risk may double for heavy smokers
  • World Geography:Higher in North America and Northern Europe
  • Diet:Diets higher in fat may increase risk

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Why Use Active Surveillance For Prostate Cancer

As noted in the American Urology Association Guidelines, a program of active surveillance is based on the premise that some, but not all, patients may benefit from treatment of their primary prostate cancer. A program of active surveillance has two goals: to provide definitive treatment for men with localized cancers that are likely to progress and to reduce the risk of treatment-related complications for men with cancers that are not likely to progress.

Role For Somatic Inherited Genetic Testing In Prostate Cancer Continues To Grow

Prostate Cancer Testing

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Leonard G. Gomella, MD, discusses the growing importance of genetic testing in prostate cancer.

The recommendations for genetic testing in prostate cancer continue to evolve, with the role for somatic testing and inherited testing becoming more pronounced, according to Leonard G. Gomella, MD, who added that the information yielded from these tests could inform personalized treatment approaches.

We should not only ask about the family history of prostate cancer. Rather, we should seek out all cases of cancer in the family. We may find other hereditary genes that are associated with the patients risk of developing prostate cancer, Gomella explained. While were starting to do more genetic testing based on buccal swabs and blood tests, need to start thinking about somatic testing, where we evaluate a very large panel of genes based on the primary tumor and the metastasis. Ultimately, this could hold the key to an optimal course of therapy for a patient.

In an interview with OncLive® during the 2020 Institutional Perspectives in Cancer webinar on Prostate Cancer, Gomella, chair of the Department of Urology at Sidney Kimmel Cancer Center, director of the Kimmel Cancer Center Network, and co-chair of the 2019 Prostate Cancer Consensus Conference, discussed the growing importance of genetic testing in prostate cancer.

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Upon Receiving Test Results How Do You Choose Among The Available Approaches

To date, very few papers have connected mutated genes with active surveillance. One paper, which was published by Johns Hopkins University a couple of years ago, suggested that a patient who had a BRCA1/2 mutation was more likely to fall off the active surveillance pathway. However, we don’t have a lot of guidelines on that yet, so, that’s one of the areas that needs more work.

This is, however, integrated into screening decisions. In fact, if one of these common hereditary breast and ovarian cancer syndromes, usually discovered when a sister, mother, aunt, or grandmother went through screening. Breast cancer, as we all know, is about 15 years ahead . Its actually a double-edged sword because these genetic alterations are much more significant in women who develop breast or ovarian cancer than they are in men who develop prostate cancer. However, if a patient does have a family history of hereditary breast and ovarian cancer, they should consider early prostate cancer screening.

At the other end of the spectrum, when it comes to treatment of localized disease, we’re not there yet. I have an inkling that in the next 5 to 6 years, we’re going to identify the men at early stages, who need an aggressive treatment, something that no other test could pick up. However, we are not there yet.

Opportunities To Improve Care

Genetic tests that aid risk stratification have the potential to reduce both over- and undertreatment of PCa. Their cost-effectiveness cannot be determined until more is known about how they influence clinical decision-making and long-term patient outcomes. For now, none of the major guidelines on PCa management provides definitive recommendations for incorporating these tests into practice.

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How Does Prolaris Impact Treatment

Since every individuals prostate cancer is different, their treatment plan should also be different. Luckily, the Prolaris test provides additional information about the aggressiveness of the cancer that is specific and unique to each patient. A Prolaris Score yields additional information about the true nature of the cancer that no other test can. Testing with Prolaris adds a new level of confidence when determining the best treatment option.

Prolaris helps to make better informed decisions.

  • Provides information no other test on the market can.
  • Helps in determining the best course of treatment.
  • Gives the physician and patient more confidence in treatment decisions.

How Is Prostate Cancer Diagnosed

Personalized medicine in prostate cancer care

Dr. Steinberg is an expert at diagnosing, monitoring, and developing treatment plans for prostate cancer. Diagnosis of prostate cancer is a multi-step process:

Medical History and Physical Exam– During an initial office visit, Dr. Steinberg will perform a Digital Rectal Exam , inserting a gloved, lubricated finger into your rectum to examine your prostate. If your doctor finds any abnormalities in the size, shape or texture of the gland, further diagnostic tests may be needed to determine if you have prostate cancer. In addition, Dr. Steinberg may ask you about any symptoms you are having, such as any urinary or sexual problems, and how long you have had them. You might also be asked about possible risk factors for prostate cancer, including your family history

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The Real Clinical Utility Of Tests Like Prolaris And Oncotype Dx In Management Of Prostate Cancer

Regular readers who are interested in gaining more understanding of the potential clinical utility of the new, gene-based prognostic tests for the management of localized prostate cancer will be interested in reading a new article on the Medscape Oncology web site.

This article covers a presentation at ASCO given by Jack M. Cuzick, PhD, of Queen Mary College University of London on the potential of the Prolaris test as well as the follow-up discussion following the presentation. It also addresses similar issues discussed by your correspondent when talking to representatives of Genomic Health at the meeting regarding their Oncotype DX test.

We dont wish to give anyone the impression that these are bad or useless tests. Clearly they arent. The available data do clearly show a significant correlation between the predictions made by these tests of risk for more or less aggressive disease and the short-term outcomes of patients after surgery and radiation therapy. However, as we have said before, all these data are based on retrospective studies, which raises the question of their day-to-day, practical, clinical value in predicting patients long-term clinical outcomes.

To quote Scott Tomplins, MD, PhD , who was one of the discussants after Dr. Cuzicks initial presentation,

Likely Place In Therapy

Prolaris would be used to help make decisions about treatment for low or intermediate-risk localised prostate cancer in people who are being considered for active surveillance or radical treatment, to estimate the risk of mortality before surgery or the risk of biochemical recurrence after prostatectomy. It would be used in addition to existing risk stratification information.

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Discordance Between Tests With Nccn Risk Criteria

byCharles Bankhead, Senior Editor, MedPage Today May 18, 2018

SAN FRANCISCO — Genomic tests to help guide treatment decisions for prostate cancer frequently pointed in different directions when used to evaluate the same patient, a small retrospective study showed.

The Decipher and Prolaris tests produced discordant results a third of the time when used to evaluate patients who met National Comprehensive Cancer Network criteria for active surveillance. The Prolaris and Oncotype DX tests disagreed a fourth of the time. Used to evaluate only two patients, the Decipher and Oncotype DX agreed on one and disagreed about the other.

Individually the tests also differed with respect to how often they supported the NCCN criteria for active surveillance. Though limited to a total of 22 patients, the results underscored the complexities of using genomic tests to select patients for active surveillance, Joseph R. Wagner, MD, of Hartford Hospital in Connecticut, said here at the American Urological Association meeting.

“What we can say from these results is that there are notable differences in favorable prognostic outcomes obtained from Oncotype DX, Prolaris, and Decipher,” Wagner said during an AUA press briefing. “For patients who are candidates for active surveillance, Prolaris is most likely to support that option. Results with Prolaris and Oncotype DX were in agreement most often.”

Disclosures

Prostate Cancer Gene Expression Testing At Ucsf

Dr. Brawer on Clinical Utility of CCP Test in Prostate Cancer

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

Commercial Success Of Prolaris

As a result of the Medicare coverage expansion to intermediate-risk patients, revenue from the Prolaris test nearly doubled in the quarter ending 31 March 2018, from US$3,400,000 to US$6,500,000, compared with the same quarter in the previous year. Prolaris testing revenue in the 2018 fiscal year reached US$20,900,000.

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Prolaris Test Accurately Predicts Risk Of Metastasis In Men Diagnosed With Localized Prostate Cancer

Validation Study Shows Prolaris Test Identifies Men Who May Benefit from Surgery or Radiation at the Time of a Prostate Cancer DiagnosisProstate Cancer and Prostatic Diseases

This study demonstrates that the Prolaris test effectively identified those men with localized prostate cancer who progressed to metastatic disease, said Stephen Bardot, M.D., a study investigator and chairman, Department of Urology Associate Medical Director, Surgical Services at the Oschner Clinic. Importantly, the Prolaris test provided critical information that can be used to determine which men with localized prostate cancer are candidates for active surveillance and which men should receive definitive therapy with surgery or radiation at the time of diagnosis.

Figure 1. Prolaris Test Accurately Predicts Risk of Prostate Cancer Progression

Oncotypedx Genomic Prostate Score

Two local Guildford charities make substantial donation to the ...

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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An Introduction To A Novel Genomic Test And Its Role In Improving Clinical Decisions: Part I: Prostate Biopsy Genomic Testing

Edited from Insights February 2014 Vol. 17 Iss. 1 | John W. Davis, MD, FACS

Associate Professor, Urology | Director, Urosurgical Prostate Program | MD Anderson Cancer Center | Houston, Texas

Contact: for readers: Office 713-792-3250 |

In 2013, the American actress Angelina Jolie made a life-altering decision that fascinated the public and made the cover of Time magazine . Based upon her family history and a genetic blood test for the BRCA1 gene, she was counseled that she had an 87% chance of developing breast cancer. This led to her decision to undergo a preventive double mastectomy. The Time article was titled The Angelina Effect and focused on the power of genomic medicine to guide clinical decision making. A family history can be considered part of clinical information and would certainly increase the odds of developing breast cancer, but only the genomic test increased those odds such that a preventive procedure became a reasonable strategy.

Diagnosis: Favorable Risk Prostate Cancer. Choice: Observe or Treat.

Biopsy Grade: Gleason 3+3

Number of involved cores: 1 or 2

Percentage of involved cores: < 50%

PSA: < 4 or similar with enlarged gland

DRE: normal or very minimal findings

References:

1. Kluger, Jeffrey . The Angelina Effect: Times New Cover Image Revealed. Time.com Retrieved May 19, 2013.

3. Klotz L. Active surveillance for favorable-risk prostate cancer: background, patient selection, triggers for intervention, and outcomes. Curr Urol Rep 2012 13: 153-9.

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