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Oncotype Testing For Prostate Cancer

The Initial Causes Description Of Oncotype Gene Testing For Prostate Cancer

Dr. Klein on Predicting Tumor Aggressiveness With Oncotype DX Test in Prostate Cancer

One of the first symptoms of prostate issues is pain or tenderness in the groin or lower back. This can be the result of a noncancerous condition called enlarged prostatic tissue, or it could be an infection of the bladder. In either case, its important to see a doctor as soon as possible. If youre suffering from prostate pain, you may want to consider reducing your caffeine intake.

Another symptom of a potentially enlarged prostate is difficulty starting a stream of urine, leaking, or dribbling. These symptoms are not serious, but theyre still alarming. Most men put up with an enlarged prostate for years before seeking medical attention, but they typically seek treatment as soon as they notice symptoms. Even if you dont have symptoms, its worth getting checked to determine if you have any prostate issues.

If you experience nightly bathroom runs, you may be experiencing an enlarged prostate. You may be having difficulty starting a stream of urine, or you may even be dribbling or leaking during the day. These problems arent life-threatening, but can become a nuisance. You should not ignore these signs and seek treatment as soon as you notice them. If you feel any of these symptoms, you should consult a doctor.

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Another type of prostate issue is chronic prostatitis, or chronic pelvic pain syndrome. This condition causes pain in the lower back and groin area, and may cause urinary retention. Symptoms include leaking and discomfort. In severe cases, a catheter may be required to relieve the symptoms. If the problem is unresponsive to other treatments, your doctor may suggest a surgical procedure. If these do not work, your symptoms could progress and become chronic.

An acute bacterial infection can cause a burning sensation. Inflammation of the prostate can affect the bladder and result in discomfort and other symptoms. This is the most common urinary tract problem in men under 50, and the third most common in men over 65. The symptoms of acute bacterial prostatitis are similar to those of CPPS. Patients may experience a fever or chills as a result of the infection.

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An enlarged prostate can also be the cause of other problems. If the enlarged prostate is causing symptoms, the best treatment would be a natural remedy. In the meantime, there are treatments for a wide range of conditions that cause a man to experience pain. A common surgical procedure involves an electric loop, laser, or electro-stimulation. The procedure is a safe and effective option for treating enlarged or symptomatic BPH.

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Executive Vice President Of Corporate Development And General Counsel

Mr. Sollee has more than 20 years of experience in the healthcare industry, including senior management roles in both private and publicly listed pharmaceuticals, health information technology and molecular diagnostics companies. He has served as chief legal counsel to MDxHealth since its inception in 2003. Prior to MDxHealth, he led the Life Sciences Practice Group at the law firm of Kennedy Covington and held senior legal and management positions at TherapyEdge and Triangle Pharmaceuticals. In addition, he has practiced as a corporate attorney in the Washington D.C. legal firm Swidler & Berlin and as an investment banker at Smith Barney in New York. Mr. Sollee received a Juris Doctorate in Law and a Masters degree in International Law from Duke University, a BA degree from Harvard University, and has been awarded New York, Washington D.C. and North Carolina legal bar certifications.

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

Gene test may help guide prostate cancer treatment

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

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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.

Chairman And Independent Director Representing Ahok Bv

Koen Hoffman has served as Independent Chairman of the Board of Directors of Fagron NV since May 8, 2017. He obtained a Master in Applied Economics at the University of Ghent in 1990 and a Master in Business Administration at Vlerick Business School in Ghent in 1991. Mr. Hoffman was appointed Chief Executive Officer of Value Square in August 2016. Prior to joining Value Square, he was Chief Executive Officer of KBC Securities, member of the supervisory board of Patria Securities and member of the board of directors of Omnia Travel Belgium. He started his career at the corporate finance department of KBC Bank in 1992.

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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 .

Genomic Test May Help Guide Prostate Cancer Treatment

Dr. Febbo Explains the Oncotype DX Genomic Prostate Score

A new genomic testthe Oncotype DX® Prostate Cancer Testmeasures the aggressiveness of prostate cancer and may help scores of men choose between immediate treatment or active surveillance. Each year in the United States, more than 240,000 men are diagnosed with prostate cancer and more than 27,000 die of the disease. Prostate cancer is typically a disease of aging. It may persist undetected for many years without causing symptoms. In fact, most men die with prostate cancer not from prostate cancer. Approximately 20% of men will develop prostate cancer during their lifetime, yet only 3% will actually die of the disease.

The treatment of early-stage prostate cancer is controversial because thus far there is no clear proof that aggressive treatment prolongs survival compared with deferred treatment. Furthermore, treatment can cause lasting side effects, such as impotence and incontinence. Some men opt for a more conservative approach, called active surveillance or watchful waitingwhich defers treatment until symptoms appear and/or there is evidence of progression. This approach can help some men avoid unnecessary treatment and potentially long-lasting side effects however, until now, it wasnt possible to predict which cancers were aggressive and required treatment and which were slow-growing and could be watched until treatment was necessary.

Reference:

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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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Prostate Cancer Oncotype Dx Results

The prostate cancer Oncotype DX test analyzes 12 genes to produce a score from 0 to 100 correlating with the aggressiveness of your cancer.

Your patient report will provide you with a rating of your cancer from very low to high risk. The report also gives you your odds of death from cancer within 10 years and the chances of your cancer progressing to a Gleason score over 4 + 3 or pT3.

Recent Studies Find Oncotype Dx Can Reliably Predict Risk Of Aggressive Prostate Cancer

Health Economic Impact and Prospective Clinical Utility of Oncotype DX ...

Based on findings from three separate studies, it appears that the 17-gene Oncotype DX® Genomic Prostate Score can help predict disease aggressiveness in prostate cancer at the time of diagnosis and therefore help physicians choose appropriate treatment. The results of these studies were published in European Urology.

The treatment of early-stage prostate cancer is controversial because thus far there is no clear proof that aggressive treatment prolongs survival compared with deferred treatment. Furthermore, treatment can cause lasting side effects, such as impotence and incontinence. Some men opt for a more conservative approach, called active surveillance or watchful waitingwhich defers treatment until symptoms appear and/or there is evidence of progression. This approach can help some men avoid unnecessary treatment and potentially long-lasting side effects however, until now, it wasnt possible to predict which cancers were aggressive and required treatment and which were slow-growing and could be watched until treatment was necessary.

The Oncotype DX prostate cancer test measures the level of expression of 17 genes across four biological pathways to predict prostate cancer aggressiveness. The test results are reported as a GPS that ranges from 0 to 100 and is combined with other clinical factors to further clarify a mans risk prior to treatment intervention.

Reference:

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Ep 1b: The Role Of Imaging And Genomic Testing In Prostate Cancer Therapy

In this companion article, Neeraj Agarwal, MD, discusses the role of genomic testing and imaging in the initial diagnosis, staging, and treatment of prostate cancer.

Results from the VISION trial announced at the 2021 American Society of Clinical Oncology Annual Meeting signaled an exciting future for precision medicine in prostate cancer. The results showed that theranostic lutetium 177-PSMA-617 significantly improved radiographic progression-free survival and overall survival when compared with best standard of care alone in patients given a diagnosis of prostate-specific membrane antigen positive, metastatic, castrate-resistant prostate cancer who had progressed after chemotherapy and hormone therapy. Further, treatment with LuPSMA revealed no unexpected or concerning safety signals. Together, these findings heralded possibilities both for the target population and for other men given the diagnosis of advanced prostate cancer.

Thus, LuPSMA opens prostate cancer to theranostics, an exciting area of precision medicine.

In the New Precision Medicine Approaches in Advanced Prostate Cancer series, experts discuss the evolving spectrum of precision medicine in advanced prostate cancer. This series features a review of NCCN guidelines, genomic testing, nuclear imaging, PSMA, advanced disease, and the rapidly developing treatment landscape and emphasizes the potential impact of newer therapies on prostate cancer treatment.

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Surgical procedures to remove the diseased prostate are usually necessary. Surgical procedures are not always necessary. If the disease is caused by bacterial infections, a doctor can treat the symptoms using alpha-blockers or surgery. Physical therapy, relaxation exercises, and warm baths are all recommended. A physician may also prescribe antibiotics to cure the infection. A bacterial infection can also cause a recurrence of the condition.

An enlarged prostate can be uncomfortable for both men and women. Some of the symptoms of an enlarged male reproductive organ include a weakened urine stream, urgent need to urinate, and urinary tract infections. BPH can also cause damage to the kidneys. A sudden inability to urinate can be life-threatening, as it can lead to bladder and kidney damage. Unfortunately, most men with enlarged prostrates put up with the symptoms for years before they seek treatment. However, many of the men with symptoms finally decide to go to a doctor for proper gynecological evaluation and to begin enlarged prostatic therapy.

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Why Your Tumors Gene Activity Matters

Not all prostate cancers are the samesome are aggressive and require treatment with surgery or radiation therapy. However, many are lower risk and can be managed with regular doctor visits and monitoring called active surveillancedelaying or completely avoiding treatments like surgery or radiation.

Its important for you to understand your personal risk before deciding on a management planwith this information in hand you can make a decision that is best suited to helping you live as long and healthy a life as possible. Oncotype DX GPS will help you and your health care team understand your individualized risk to better inform decisions about what happens nextactive surveillance or treatment.

Your Prostate Your Decision

Point-Counterpoint: Oncotype Dx Genomic Prostate Score in Active Surveillance Canary PASS Study

Just as every patient is different, so is every prostate cancer tumor. The GPS test uses genomics to give you and your doctor important risk information about how your individual tumor will likely behave. Valuable insights include:

  • How aggressive your cancer is
  • How likely you are to die from your cancer within 10 years of surgery
  • How likely your cancer is to spread to other parts of your body within 10 years of surgery

Your GPS result can help you and your doctor determine what type of treatment is right for you based on your tumors characteristics.

More than 1.5 million breast, prostate, and colon cancer patients have relied on an Oncotype DX® test for insights that help guide their treatment decisions

The test provides crucial information, such as the aggressiveness of your tumor and predictive tumor behavior to help you make confident treatment decisions

Risk estimates to help predict the benefit of surgery and radiation

Many localized prostate cancers are lower risk and not likely to be aggressive. They can be managed with active surveillance and regular doctor visits, thus delaying or completely avoiding the need for additional treatment

The GPS test is included in the NCCN Clinical Practice Guidelines in Oncology for prostate cancer

As a Category 2A molecular testing option for consideration in prostate cancer patients with low-risk and favorable intermediate-risk disease

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Reference Gene Normalization And Genomic Prostate Score Calculation

The five reference genes were selected in an independent study for their low inter-patient variability, lack of relationship to clinical outcome and robust analytical performance . Reference gene normalization was used to adjust for potential sources of pre-analytical variability, such as fixation, RNA fragmentation and tissue quality, analytical variation including assay plate and instrumentation , and varying RNA inputs . Gene expression was normalized by subtracting the aggregated expression of the reference genes from the weighted mean Cp for each of the 12 informative genes and centering by adding 10 units to the result. The formula used to calculate the GPS is shown in Figure 1.

Calculation of Genomic Prostate Score . The aggregate expression of 5 reference genes was used to reference normalize the expression of the 12 cancer-related genes. Normalized gene expression was used to calculate the individual group scores: stromal group score, cellular organization score, androgen groups score and proliferation score. Each of those group scores is algorithmically combined to calculate the unscaled Genomic Prostate Score the GPSu is then scaled to a 100-unit range GPS. A negative coefficient in the calculation of the GPS is associated with better outcome whereas a positive coefficient is associated with poorer outcome.

Independent Director Representing Hilde Windels Bvba

Ms. Windels has over 20 years of experience in the biotechnology sector with a track record of building and structuring organizations, fundraising, M& A, public capital markets and corporate strategies. At Biocartis, she was CEO and interim and Deputy CEO from September 2015 until September 2017 and CFO from 2011 until September 2015. Previously, Mrs. Windels worked as an independent CFO for several private biotech companies, and from 1999 to 2008 she was CFO of Devgen. Currently, Mrs. Windels is a consultant in the life sciences industry and serves as a board member at Erytech, Celyad and GIMV. In the past, she also served on the boards of Devgen, Biocartis, Ablynx, VIB, and FlandersBio. Mrs. Windels holds a Masters in Economics from the University of Leuven, Belgium.

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