The New Prostate Health Index Test

In 2003, 220,900 new cases of prostate cancer were diagnosed.  This number is estimated to reach 450,000 by 2015. In order to diagnose these new cases, there are roughly 1.5 million prostate biopsies per year with about 25 million men who have had at least one negative biopsy.  How can we improve diagnosis and treat all these patients?  Ideally, through a non-invasive, low cost, and effective therapy.  With a new, a three-pronged blood test, this improved standard of care may already be here.

The Prostate Health Index (PHI) test, now available nationwide through Innovative Diagnostics Laboratory, could fill the diagnostic gap clinicians currently have when screening for prostate cancer.  By using three different prostate specific markers, the test is three times more specific for prostate cancer than the current PSA test.  Over the last several years, there has been much debate in the realm of over-screening, over-diagnosis, and the inaccuracy of diagnostic tools in prostate cancer.  This test greatly improves this dilemma by giving clinicians more accurate information on what an elevated PSA level might mean and the probability of finding cancer on a biopsy. This improvement will allow a decrease in the number of prostate biopsies that are negative for cancer and done unnecessarily each year.

What is wrong with our current standard of testing?  Simply, the PSA (prostate specific antigen) is not specific to prostate cancer.  Elevations can be seen with any prostatic disease including prostatitis, BPH, and prostate cancer.  Below are a few other factors which will also affect PSA levels:

  1. Prostate Biopsy or prostate massage: Either will increase PSA levels temporarily.
  2. Race: African-Americans have higher baseline PSA levels than Caucasians.
  3. Prostate volume: Increase in PSA level of 4% for every mL of prostate volume.
  4. Age: Older men have a higher baseline PSA.
  5. 5-alpha reductase inhibitors (Finasteride and Dutasteride): This class of drugs is used in treating BPH and male pattern baldness.  Will decrease PSA by 50% after 6 months of therapy.

As you can see, physicians and patients alike are faced with challenges with the current standard for prostate cancer diagnosis, which is based on the fact that men with higher levels of the PSA protein are more likely to have prostate cancer.  This lack of specificity can lead to false‐positives for cancer and ultimately unnecessary biopsies. The PHI test promises to better distinguish prostate cancer from non-cancer disorders.  This is done by using a process that evaluates three different PSA markers: PSA, free PSA and p2PSA.  This new test will more reliably determine the likelihood of cancer in patients with elevated PSA levels.

According to Innovative Diagnostics, results from the PHI are meant to determine probability of cancer in men over 50 with a total PSA results between 4 and 10 ng/mL and negative digital rectal examination (DRE) findings. We hope that the accuracy of this test will decrease the need for many men who test positive for elevated PSA levels to have to get a biopsy in order to get a dependable diagnosis.

For more information about prostate cancer and diagnostic tools you can call your urologist or visit

David Samadi, MD - Medical Contributor

View posts by David Samadi, MD - Medical Contributor
Dr. Samadi is a board-certified urologic oncologist trained in open and traditional and laparoscopic surgery and is an expert in robotic prostate surgery. He is chairman of urology, chief of robotic surgery at Lenox Hill Hospital and professor of urology at Hofstra North Shore-LIJ School of Medicine. He is a medical correspondent for the Fox News Channel's Medical A-Team. Learn more at Visit Dr. Samadi's blog at Follow Dr. Samadi on Twitter, Instagram, Pinterest, and Facebook.
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