What is Prolaris®?

Prolaris® is a genomic test developed to aid healthcare professionals in predicting prostate cancer aggressiveness in conjunction with clinical parameters such as Gleason score and PSA, in order to better define the treatment and monitoring strategy for their patients.

Prolaris® functions as a risk stratification tool that measures the aggressiveness of a patient’s prostate cancer to better predict that individual’s risk of disease progression within ten years.

The prostate-specific antigen (PSA) level and the Gleason score tell a doctor how far the cancer has progressed, but not necessarily the “aggressiveness” of the disease. A Prolaris® Score™ will provide both the patient and physician additional information about the true nature of the cancer. By measuring the expression levels of genes involved in cancer cell proliferation, Prolaris® is able to assist the physician in recommending a personalized treatment plan.

Who should take the test?

Prolaris® can be performed only on patients that have undergone a biopsy or prostatectomy. Men with prior pelvic radiation and/or androgen deprivation or metastatic disease are not eligible.

Prolaris® is recommended for patients with localized prostate cancer at the time of initial of diagnosis and in the post-surgery settings:

At diagnosis, Prolaris® can help to identify patients with less aggressive cancer who may be candidates only for active surveillance.

Prolaris® testing is well suited for use in post-prostatectomy patients who have higher risk features after surgery (adverse pathology) to better estimate their risk of disease recurrence (biochemical recurrence, or BCR) and therefore adjust the level of monitoring or add additional therapy.

The result of the Prolaris® test is unique to each patient.

What are the clinical benefits of the test?

Prolaris® is the in-depth assessment of the prostate cancer aggressiveness that shapes patients’ lives, by avoiding unnecessary treatments that bring unwanted side effects, costs, and trauma to their families.

Prolaris® provides a 10-year prostate cancer-specific mortality risk by directly measuring tumor cell growth characteristics and combining this with important clinical and pathological features for stratifying the risk of disease progression in prostate cancer patients.

Prolaris® has been shown to be the single most clinically significant prognostic parameter of outcomes at the time of diagnosis. Clinical parameters, such as Gleason score, will continue to serve as the standard measurement for prostate cancer severity, but they do not measure the true hallmark of cancer – cell proliferation.

Prolaris® unique additional information is combined with standard clinical factors and it adds confidence in disease management decisions.

With Prolaris®, patients and doctors become partners in the journey to faster, smarter and more efficient personalized medical solutions.

What sample is required to perform the test? 

When submitting prostate needle biopsy samples for testing, Prolaris® requires a small amount of quality tumor to run the test, consisting in at least 7 consecutive slides, each 3 – 5 microns in thickness with tumor that is at least 0.5mm in length.

When submitting post-prostatectomy samples for Prolaris® testing, the submission of tumor blocks is preferred over tumor slides. Ideally, tumor size should be at least 5mm in length on the diagnostic H&E slide.

Frequently Asked Questions

How does a patient know if he is appropriate for Prolaris® testing?

Any man who has been diagnosed with localized prostate cancer is appropriate for Prolaris® testing, if no therapeutic measure has been yet applied.

Why should a patient get Prolaris® testing?

Not all prostate cancers are the same. The prostate-specific antigen (PSA) level and the Gleason score tell the physician how far the cancer has progressed, but not necessarily the “aggressiveness” of the disease. Two patients with the same PSA and Gleason scores may have a very different estimate of mortality risk when their Prolaris® Score is included in their evaluation. Since cancer is the uncontrolled rapid growth of abnormal cells, an aggressive prostate tumor carries the potential risk of growing and spreading rapidly to other parts of the body.
Getting a Prolaris® Score will tell the doctor additional information about the disease, which will help in determining its aggressiveness and guide the patient towards the most optimal treatment plan that’s tailored specifically for his case, thus avoiding unnecessary treatments that bring unwanted side effects, costs, and trauma to his family.

How are the metrics in Prolaris® testing calculated?

The Prolaris® Molecular Score™ is calculated by measuring the expression of cell cycle progression genes in the tumor. This shows theaggressiveness of the individual tumor.
The majority of Prolaris® Scores will fall between 0 and 10 with a higher score indicating more aggressive cancer. For every one unit increase in the Prolaris® Score, the patient’s risk doubles.
Clinical variables and the Prolaris® Molecular Score are used to calculate a patient’s risk assessment.
For considering active surveillance, the 10-year disease specific mortality (DSM) risk with conservative management is shown to be within or beyond the Active Surveillance Threshold. Patients with a DSM within the Active Surveillance Threshold may be considered appropriate for conservative management.
For considering primary radiation therapy or radical prostatectomy, the 10-year risk of developing metastasis with definitive treatment (prostatectomy or primary radiation) is provided.

What are the treatment options for men with prostate cancer

Men with localized prostate cancer have many treatment options, including:
• Active surveillance
• Surgery
• Radiation therapy
• Hormone therapy
• Chemotherapy and new therapies
These treatments may also be used alone or in combination with one another. The doctor should be able to describe the treatment choices, the expected results, and the possible side effects of each treatment.

How long does it take to get the test results

Prolaris® test results will typically be available within 21 business days following receipt of the sample at the lab, subject of adequate available DNA content.

How does the test work?

Prolaris® testing is easy and is appropriate for all localized prostate cancer patients. The test provides an analysis of the individual tumor aggressiveness, in addition to the clinically validated prostate cancer specific mortality and metastasis risk.

The Prolaris® Molecular Score™ is combined with clinical variables in a clinically validated weighted algorithm to calculate the individual 10-year prostate cancer disease specific mortality when treated conservatively and 10-year metastasis risk when treated with primary radiation therapy or radical prostatectomy.

Prolaris® testing should be done following an affirmative biopsy and prostate cancer diagnosis. Prolaris® testing on the biopsy tissue can help determine, in addition to traditional clinical features like Gleason and prostate-specific antigen (PSA), the aggressiveness of cancer to measure the cancer’s proliferation.

A Prolaris® score™ will:

Help differentiate patients with similar risk profiles.

Help better assess the specific risk of the prostate cancer mortality.

Help individualize prostate cancer treatment decisions for the patients.

Prolaris® has been proven to predict disease specific mortality in prostate cancer patients following needle biopsy. Prolaris® testing is also well-suited for post-prostatectomy patients to better estimate the risk of biochemical recurrence (BCR) within ten years. Prolaris® can identify patients who may be candidates for surveillance as well as patients who may be potentially at higher risk and benefit from closer monitoring or additional therapy.

When it comes to prostate cancer, there are many different factors that can increase a man’s risks of getting prostate cancer. These risks include age, race, nationality and the family history. When it comes to the level of aggressiveness, most prostate tumors tend to be slow growing, but 10-15% of men diagnosed with prostate cancer have fast-growing, life-threatening prostate tumors.

Luckily, the Prolaris® test can help the patient and his doctor determine just how aggressive the prostate cancer is, and what cancer treatment plan is best in his situation. Results from the Prolaris® test have changed treatment plans for 65% of men.*

*Crawford ED, et al. Cell cycle progression score and treatment decisions in prostate cancer: results from an ongoing registry, Current Medical Research and Opinion 2014, 30(6), 1025-1031. Available at http://informahealthcare.com/doi/abs/10.1185/03007995.2014.899208

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