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PHI NOW AVAILABLE IN THE US - more accurate than PSA

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Posted 4/24/2014 5:44 PM (GMT 0)
Beckman-Coulter today announced that the FDA-approved Prostate Health Index (PHI) test is available now in the US. It has been used in Europe for years already. Because it is not affected by prostatitis, BPH or urinary retention- it tests for a kind of PSA only released by PC called -2ProPSA - it has the potential to increase cancer detection without increasing unnecessary biopsies. At a cut-off value of 25, PHI will detect cancer in two-thirds of men who have PC, while sending a third of men without PC for unnecessary biopsies*. This contrasts with the PSA test that at a cut-off of 2.0 to send men to a biopsy is missing almost half of the cancers and sending 28% of men who have no cancer to unnecessary biopsies.

It also has a role to play in Active Surveillance. It is more sensitive than PSA in detecting higher Gleason scores, higher tumor volumes, and metastases.

It is determined via a blood test that your doctor can order through Innovative Diagnostics. Medicare covers it, and they guarantee that your health insurance plan will cover it too.

It's not a perfect test, and it won't eliminate all overdetection, but it's a step along the way.

*among men with PSA between 2-10 and negative DRE
Posted 4/24/2014 5:56 PM (GMT 0)
Tall -

How would you compare this test to the Mi-Prostate test, which is also now available to patients?

http://www.mlabs.umich.edu/files/pdfs/MiPS_FAQ.pdf

http://www.pathology.med.umich.edu/handbook/?search=MIPS

 

Posted 4/24/2014 6:32 PM (GMT 0)
medved,

They are in some ways complementary. PHI is a high sensitivity test - it improves detection of cancers that are there, while Mi-Prostate is a high specificity test, meaning that it won't send many men to unnecessary biopsies if it is positive.

From what I can tell, Mi-Prostate is just two tests - the PCA3 test and a TMPRSS2:ERG fusion test. PCA3 is covered by insurance after a first negative biopsy if suspicion remains. Many cancers do not express PCA3, but if it does, it's a good indicator (low sensitivity, high specificity).

TMPRSS2:ERG fusion is not covered by insurance at all. The ERG fusion test also is not great -- it has low sensitivity for prostate cancer -- about half of cancers seem to express it, and some normal prostates express it too. So it misses a lot of cases when it is there, and the value to avoid unnecessary biopsies is quite high. But if it is very high, it's a good indicator.

Combining the two increases the accuracy - if the cancer does not express one, perhaps it expresses the other. Like the other genetic tests (e.g., Prolaris, Oncotype Dx), it probably will not be worth paying for for the average guy, but if money is no object, why not? Even so, it would be good to get PHI in addition in order to get a higher detection rate.
Posted 4/24/2014 7:52 PM (GMT 0)
Allen,

Thanks for the heads up on this...

I did note in the article that it says, "After years of collaboration with some of the world's leading prostate cancer researchers and medical institutions who have studied the scientific and clinical benefits of phi, we are pleased that the test is now available to help physicians and patients with an elevated PSA test result, more accurately detect prostate cancer,".

 

 

A couple of quesitons:

 

1.  So will the plan moving forward be that doctors will do a PSA test and if elevated...then do a PHI test or will doctors start with ordering the PHI test?

2.  If men still need to have a PSA test to see if it is elevated...and then get a PHI test then hopefully this will help the USPSTF change their mind about their recommendation of no prostate cancer screening.

3.  I'm always looking for additional and/or better cancer markers for my own cancer.  Does this test help after you've had treatment(s) to monitor PC status?  For example, I've had surgery and radiation.  Can I now use this with PSA as an additional marker?

Thanks again...great information and timely...

Jerry 

 

Posted 4/24/2014 9:42 PM (GMT 0)
Allen this is at the PCAF site. I have made available a presentation on the PHI test.

advancedpcatalk.freeforums.net/thread/98/improving-biopsy-phi-big-help

No login needed to view it.
Posted 4/24/2014 10:37 PM (GMT 0)
Thanks Tony...

My kindle was able to read your slides, ppt...but for some reason my laptop with IE9 had issues....just fyi...

I haven't really kept up on the Phi testing...very interesting...look forward to learning more.

Posted 4/24/2014 10:42 PM (GMT 0)
Jerry,

1. I still think it's a good idea to rule out confounding sources of PSA increase. PHI, while an improvement over PSA, still is not the single test that will eliminate over-detection of PC. Because it has only been validated for PSAs between 2-10 and a negative DRE, one would still want a normal PSA test first, I think. In fact, one would probably want a PSA history, a DRE, and PSA density.

2. It doubt it will change their minds in the short term. I have no idea what USPSTF will do, but they are looking for high-level evidence that a new biomarker will not lead to overtreatment the way PSA has. That kind of evidence will take a long time to accumulate. PHI is better, but still not very good at distinguishing those cancers that require immediate treatment from those that don't. An increase in the utilization of Active Surveillance may do more to change their minds, imho.

3. To my knowledge, PHI has not been tested for use after salvage RT. Because surgery removes the prostatic sources of PSA, PSA becomes a very good indicator of cancer progression, rendering PHI superfluous. TMPRSS2:ERG fusion increases with disease progression in many cases, but I'm not sure how knowing that would make a difference in your treatment.

- Allen
Posted 4/24/2014 11:01 PM (GMT 0)
Tony,
Thanks for the link. I attended a presentation sponsored by Beckman-Coulter back in June 2012 by Dr. Kevin Slawin who was the lead inventor and also the inventor of the free PSA test. I'm not sure why it took them so long to make it available in the US. Perhaps the recent release of the 4Kscore egged them on. I did my own presentation on it for my PC Support group back then. It is highly technical and full of charts showing comparative sensitivities, specificities & AUCs. I wouldn't know how to post it here, but perhaps I will dust it off and post it on the PCAF site.

- Allen
Posted 4/24/2014 11:12 PM (GMT 0)
Thanks Allen...
Posted 4/24/2014 11:29 PM (GMT 0)
Allen I can post it in my SlideShare account or Google drive account. And if it can be compressed enough you can post it at PCAF (1m limit as of right now) How big is it?
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