Prolaris®

by Myriad Genetics, Inc.

Prostate cancer develops in men in their prostate gland. This is a small (walnut sized) gland in the reproductive system located under the bladder, and in front of the rectum. This gland makes part of the seminal fluid that carries sperm out of the body during ejaculation.

The prostate surrounds the urethra, the tube that carries urine from the bladder to the penis. Because of that, one common sign of prostate problems is difficulty in urinating.

It is not yet known what specifically causes prostate cancer. However, there are some common risk factors — things that may increase the chance of getting a disease. Research has shown that men with these risk factors are more likely than others to develop prostate cancer. The main risk factors are race, age, and family history. The average age at the time of diagnosis is 70. It is rarely found in men younger than 45.

In its earliest stages, prostate cancer usually grows quietly, causing no detectable signs or symptoms. You can screen for prostate cancer risk during these early stages before symptoms appear with a simple PSA blood test. Because of PSA testing, most cancers are found before a man has ever had a single symptom.

Once the cancer has advanced it can cause these symptoms:

  • Trouble starting and maintaining a steady stream of urine
  • Weaker urine stream than usual
  • Frequent urination
  • Increased urination at night
  • Painful urination
  • Blood in the urine or the semen
  • Swelling in the legs
  • Pain or discomfort in the pelvic region
  • Pain in the bones
  • Difficulty achieving erection
  • Painful ejaculation

Tumors in the prostate are not always cancerous. There are benign (non-cancer) tumors, and malignant (cancer) tumors.

Benign prostatic hyperplasia (BPH) is a non-cancerous tumor in the prostate. It makes the prostate grow larger and squeezes the urethra, which causes changes in urination. BPH is very common in the US. In fact, most men over 50 have some symptoms of BPH. Sometimes the symptoms require treatment, but not cancer treatment. Although it is not cancer, BPH can increase your PSA test results. Benign growths are rarely life-threatening, can be removed permanently, and don’t spread to other parts of the body.

Malignant, or cancerous, tumors cause many of the same symptoms as benign tumors, so it is important to be tested to determine which kind of tumor you have.

Malignant tumors may be life-threatening, can be removed but sometimes grow back, can invade nearby tissues and organs, and can spread to other parts of the body.

What is Polaris®?

Prolaris® is a test that measures how fast the cells in your tumor are dividing. Since you have had a biopsy, that tissue sample can be used to determine your Prolaris Score. Studies have shown that Prolaris provides an accurate assessment of cancer aggressiveness. And, because every individual’s prostate cancer is different, the result of your Prolaris test is unique to you.

Your Prolaris Score can help you and your doctor make the best treatment decision for you. For example, if you have a low-risk cancer and a low Prolaris Score, you and your doctor may choose to delay treatment and just monitor it closely. This is called active surveillance. On the other hand, if your Prolaris Score is high, meaning a more aggressive cancer, you and your doctor may choose to treat your cancer with an aggressive therapy.

After you receive the results of your test, you and your doctor will decide your course of treatment. The added information from the Prolaris Score can allow you to have more confidence in the decisions you make about your medical care.

What can Prolaris® do?

Prolaris® was developed to help doctors predict prostate cancer aggressiveness, together with other clinical variables, such as: the Gleason score and PSA levels. Technically, Prolaris measures how fast your tumor is growing to predict disease outcome.

What Prolaris® measures is not whether you have prostate cancer, but how fast your cancer cells are dividing, or its aggressiveness. Because all prostate cancers are not the same, getting a Prolaris® Score will tell your doctor additional information about your cancer, which will help in determining its aggressiveness.

The signature has been evaluated in four clinical studies:

  • A study of 366 patients which predicted biochemical recurrence in patients who had undergone radical prostatectomy
  • A study of 413 patients which predicted biochemical recurrence in patients who had undergone radical prostatectomy
  • A study of 337 patients which predicted ten year mortality risk in patients with clinically localized prostate cancer diagnosed by transurethral resection and managed conservatively (watchful waiting)
  • A study of 352 patients which predicted ten year mortality risk in patients with clinically localized prostate cancer diagnosed by needle biopsy and managed conservatively (watchful waiting)

Prolaris was a statistically significant predictor of clinical outcomes in all four studies. Prolaris provides unique additional information about your prognosis and may be used with other clinical factors to help your doctor recommend the treatment that you need.

How will Prolaris® testing benefit me?

Your Prolaris® Score can help you and your doctor make the best treatment decision for you. For example, if you have a low-risk clinical features and a low Prolaris® Score, you and your doctor may choose to delay treatment and just monitor it closely. This is called active surveillance. On the other hand, if your Prolaris® Score is high, meaning a more aggressive cancer, you and your doctor may choose to treat your cancer with an aggressive therapy.

If you had a prostatectomy or primary EBRT (External Beam Radiation Therapy), Prolaris® helps to estimate the likelihood that the disease may return. This information may change the level of monitoring or therapy recommended by your physician.

After you receive the results of your test, you and your doctor will decide your course of treatment.

Prostate Cancer and Prolaris® FAQs

[accordion][accordion-item title="How do I get tested?"]Speak to your doctor. Once your doctor orders a test for you from us, we will take care of the rest. The clinic will take a small blood sample and send it to the lab for testing. The lab cannot accept a test directly from you, as a doctor first needs to assess whether or not the test is right for you. Once the testing is completed, a report will be sent to your doctor who will then go through and explain your results to you, and suggest the next steps. [/accordion-item][accordion-item title="Can I use any other sample collection kit that is not provided by Myriad?"]No! Our processes have been optimized and validated with the kits we provide.[/accordion-item][accordion-item title="Which completed forms must accompany my sample?"]The clinic will help you complete and sign an Informed Consent Form. This form will be submitted with the sample. The consent form will be used to match your sample to the test request submitted by the doctor, and is needed to let the lab know that you have agreed to send your sample for the test. Samples received without these forms cannot be processed, as your consent is required to test your sample. [/accordion-item][accordion-item title="Who will receive the test results?"]Myriad will provide your test report to the healthcare professional who ordered the test. [/accordion-item][accordion-item title="Why are the results of testing sent directly to the ordering healthcare professional rather than the patient or parent of a patient?"]Results are sent to the ordering healthcare professional as they would need to discuss the results, result interpretation, treatment management, and any follow-up testing with you.[/accordion-item][/accordion]