Prostate Health Index Blood Test

Phi As A Component Of Multivariable Risk Stratification

Dive into Dx: phi

There has been a paradigm shift in prostate cancer decision-making from a one-size-fits-all approach using total PSA, as was done in the early 1990’s, toward multivariable risk assessment taking into account individual patient characteristics. Such an approach is recommended by numerous contemporary clinical practice guidelines, such as the Melbourne Consensus statement.10

Given the substantial international evidence showing the superiority of phi over PSA, several tools have been created that combine phi with other clinical risk factors to aid in prostate biopsy decisions. Lughezzani et al. reported a study including 729 men from a major tertiary referral center in Italy undergoing extended prostate biopsy .11 These men had total PSA levels ranging from 0.5-20 ng/ml, and 17.7% had a suspicious DRE. Similar to the previous studies, phi had superior predictive accuracy for biopsy outcome compared to %fPSA or total PSA . The addition of phi to a multivariable model with age, prostate volume, DRE and prostate biopsy history led to a statistically significant 7% gain in predictive accuracy. The authors created a nomogram combining these 5 variables, which had an AUC of 0.80. The nomogram was well calibrated for men at low to intermediate risk. Of note, using PSA or %fPSA in the nomogram instead of phi resulted in significantly inferior predictive accuracy .

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Tests To Diagnose And Stage Prostate Cancer

Most prostate cancers are first found as a result of screening. Early prostate cancers usually dont cause symptoms, but more advanced cancers are sometimes first found because of symptoms they cause.

If prostate cancer is suspected based on results of screening tests or symptoms, tests will be needed to be sure. If youre seeing your primary care doctor, you might be referred to a urologist, a doctor who treats cancers of the genital and urinary tract, including the prostate.

The actual diagnosis of prostate cancer can only be made with a prostate biopsy .

Ct Scanning Mri And Bone Scanning

Men with PSA levels above 10 ng/mL, high-grade histology , or physical findings that suggest stage T3 disease should probably undergo a staging computed tomography scan and bone scan. CT scanning is the one modality with evidence-based guidelines. The CT scan can be used to evaluate extension into the bladder and lymph nodes to help stage the patient’s cancer or to consider lymph node sampling prior to treatment.

According to the National Comprehensive Cancer Network , technetium-99m-methyl diphosphonate bone scan is indicated in the initial evaluation of patients at high risk for skeletal metastases, as indicated by any of the following :

T1 disease, PSA 20
Symptoms suggestive of osseous metastasis

The NCCN recommends pelvic CT or magnetic resonance imaging in patients with any of the following:

T1-T2 disease and nomogram-indicated probability of lymph node involvement > 10%

Conventional endorectal MRI is helpful for localizing cancer within the prostate and seminal vesicles and for local staging. Dynamic, contrast-enhanced MRI and MR spectroscopic imaging are complementary in local staging, but their use is currently limited to a research setting.

Detection of large and poorly differentiated tumors
T staging: Detection of extracapsular extension, with high negative predictive values in low-risk men
N staging: MpMRI is equivalent to CT scan
M staging: MpMRI outperforms bone scan and targeted x-rays for M staging, with 98-100% sensitivity and specificity

Need For This Guidance

New Zealand men currently receive conflicting advice about prostate cancer testing and treatment. Some men may benefit from early diagnosis and treatment, but have limited opportunity to access appropriate health services.

Unlike other cancers, prostate cancer often grows slowly. With routine prostate specific antigen testing, many men can be diagnosed with a cancer that is not going to progress during their lifetime. Such a diagnosis may increase mens exposure to unnecessary treatment-related harms.

On the other hand, some men will still develop aggressive and potentially life-threatening prostate cancer. These men may benefit from prompt diagnosis and treatment.

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What Other Test Are Available For Men At Risk For Prostate Cancer

While traditionally, the options available to men at risk for prostate cancer were limited to PSA blood test and a prostate exam , a number of exciting innovative options are now available.

PSA is still a useful test but is being supplanted by more informative tests such as 4KScore and PHI , both of which incorporate the traditional PSA test as well. Thus, the report will list both the traditional PSA test and the 4KScore or PHI score respectively.

PHI is a new test that provides an incremental improvement over the PSA test alone when it comes to predicting the risk of prostate cancer. It can be used to reduce the need for unnecessary biopsies in some men.

If you have any questions, to schedule a consultation or if you need a second opinion, pleasecontact us or call:

Prostate Health Index Testing

HealthWatch: New Blood Test Can Improve Screenings For Prostate Cancer

The Prostate Health Index test is a diagnostic blood test that combines free and total PSA and the pro-PSA isoform . The PHI test is intended to reduce the number of unnecessary prostate biopsies in PSA-tested men. In prospective multicenter studies, the PHI test has outperformed free and total PSA for detection of prostate cancer and has improved prediction of clinically significant prostate cancer in men with a PSA of 2 or 4 ng/mL to 10 ng/mL.

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Comparison Of Phi To Other Prostate Cancer Tests

Several other marker tests are commercially available for prostate biopsy decisions. One of these is the 4 kallikrein panel , which is conceptually similar to phi by using a combination of PSA-based markers and has also been validated in US and European populations to improve specificity.23 Both are presented as options in the 2015 National Comprehensive Cancer Network Guidelines.24 Unlike phi which is FDA approved, the 4KScore is a CLIA-certified test and is currently more expensive in the U.S. In a comparative study including 531 Swedish men, phi and the 4KScore had similar discrimination for overall prostate cancer detection and high-grade disease .25 Both markers provided significant incremental value compared to a model with PSA and age alone. A key difference between the tests in clinical practice is that the 4KScore uses a proprietary algorithm which also incorporates the patient’s age, DRE and prior biopsy status along with the 4 kallikrein markers to estimate the number of men it is necessary to biopsy to find one high-grade prostate cancer. Although either test can be used for decisions about initial or repeat biopsy, the 4KScore does not yet have a validated algorithm for active surveillance.

Specialist Referral And Biopsy

Your doctor will discuss your prostate check results with you. If the PSA and DRC results suggest you have a high risk for prostate cancer, your doctor will refer you to a urologist .

The specialist will discuss having a prostate biopsy, in which a small sample of your prostate gland cells are taken for examination.

The aim of the biopsy is to confirm whether or not you have prostate cancer and, if so, whether it needs treatment. The treatment options will then be discussed with you.

If the biopsy shows no evidence of cancer, you may be advised to attend future check-ups.

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How Is The Psa Test Used In Men Who Have Been Treated For Prostate Cancer

The PSA test is used to monitor men after surgery or radiation therapy for prostate cancer to see if their cancer has recurred . If a mans PSA level begins to rise after prostate cancer treatment, it may be the first sign of a recurrence. Such a biochemical relapse typically appears months or years before the recurrence causes symptoms.

However, a single elevated PSA measurement in someone who has a history of prostate cancer does not always mean that the cancer has come back. Someone who has been treated for prostate cancer should discuss an elevated PSA level with their doctor. The doctor may recommend repeating the PSA test or performing other tests to check for evidence of a recurrence. The doctor may look for a trend of rising PSA level over time rather than a single elevated PSA level.

A rising trend in PSA level over time in combination with other findings, such as an abnormal result on imaging tests, may lead the doctor to recommend further cancer treatment.

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6 Tests to Diagnose Prostate Cancer: Symptoms & Treatment

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If Screening Test Results Arent Normal

If you are screened for prostate cancer and your initial blood PSA level is higher than normal, it doesnt always mean that you have prostate cancer. Many men with higher than normal PSA levels do not have cancer. Still, further testing will be needed to help find out what is going on. Your doctor may advise one of these options:

Waiting a while and having a second PSA test
Getting another type of test to get a better idea of if you might have cancer
Getting a prostate biopsy to find out if you have cancer

Its important to discuss your options, including their possible pros and cons, with your doctor to help you choose one you are comfortable with. Factors that might affect which option is best for you include:

Your age and overall health
The likelihood that you have prostate cancer
Your own comfort level with waiting or getting further tests

If your initial PSA test was ordered by your primary care provider, you may be referred to a urologist for this discussion or for further testing.

Early Detection Saves Lives

Prostate cancer is the most common cancer affecting Australian men .

Prostate cancer is the growth of abnormal cells in the prostate gland. This gland is only found in males and is about the size of a walnut.

The causes of prostate cancer are not understood and there is currently no clear prevention strategy.

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Getting A Prostate Biopsy

For some men, getting a prostate biopsy might be the best option, especially if the initial PSA level is high. A biopsy is a procedure in which small samples of the prostate are removed and then looked at under a microscope. This test is the only way to know for sure if a man has prostate cancer. If prostate cancer is found on a biopsy, this test can also help tell how likely it is that the cancer will grow and spread quickly.

For more details on the prostate biopsy and how it is done, see Tests to Diagnose and Stage Prostate Cancer.

For more information about the possible results of a prostate biopsy, see the Prostate Pathology section of our website.

Executive Vice President Of Corporate Development And General Counsel

New blood test improves prostate cancer screening

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.

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What Is The Phi Test

The PHI or Prostate Health Index test is a blood test that is used to predict the risk of having prostate cancer in men. The PHI test is used instead of the traditional PSA test. The Prostate Health Index test is actually derived from the PSA test. The PHI test is a combination of the free PSA, total PSA, and the proPSA isoform of free PSA. These 3 tests are mathematically combined in a formula that results in a Prostate Health Index or PHI score. The PHI score is a better predictor of prostate cancer than the total PSA test alone or the free PSA test alone. The Prostate Health Index is also a better predictor of prostate cancer risk than the free PSA to total PSA ratio or the free PSA ratio.

The PHI test offers better sensitivity as well as better sensitivity for prostate cancer. This means that men with a low score are less likely to have prostate cancer and those with a higher score are much more likely to have prostate cancer.

Prostate Health Index Test

In recent years, there has been a significant focus on making early detection screening tests more accurate. What if there was a formula or prostate health calculator to make the PSA tests more accurate? This is almost precisely what the Prostate Health Index is used for. Although it is not an actual prostate health calculator, the PHI is an FDA-approved blood test that uses a mathematical formula that combines the results of Total PSA, Free PSA, and p2PSA to determine a score representing the probability of prostate cancer in an individual. The Prostate Health Index test score can help identify or classify a mans risk for developing prostate cancer and thus, reducing unnecessary biopsies. The PHI should not be used as an initial test for early screening, and based on the PSA test, your doctor will determine whether or not to use the prostate health index formula.

One of the reasons why the PSA test was considered controversial in the 1990s is that the blood test results often cant distinguish between prostate cancer and benign conditions. Hence, results were not always considered conclusive – PHI helps to differentiate between the two.

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Independent Director Representing Regine Slagmulder Bv

Dr. Regine Slagmulder is a partner and full professor in management accounting & control at Vlerick Business School. Previously, she worked as a strategy practice consultant at McKinsey & Company. She also previously worked as a professor of management accounting at INSEAD and at the University of Tilburg. She serves. as an independent director and chair of the audit committee on the board of the investment company Quest for Growth. and of Ekopak , both listed on Euronext. Dr. Slagmulder graduated in civil electrotechnical engineering and industrial management from the University of Ghent, after which she took a management doctorate at Vlerick Business School. As part of her research activities, she was a research fellow attached to INSEAD, Boston University and the P. Drucker Graduate Management Center at Claremont University .

What Happens If My Psa Level Is Elevated

Biomarkers and genomics in prostate cancer

If you have a high PSA level, you will need ongoing PSA tests and DREs so your provider can look for any changes. If the PSA level continues to increase or if your healthcare provider finds a lump during a DRE, you may need other tests, including:

Transrectal ultrasound and prostate biopsies.
Iso PSA or 4Kscore® .

A biopsy can tell you definitively if you have prostate cancer. The biopsy results also affect your treatment. For example, if the biopsy shows a lot of cancer cells, you might need more aggressive treatment.

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