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  • “ExoDx” – Impressive New Urine Test for Biopsy Decision Making!

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    Old 07-31-2020, 12:33 PM   #1
    IADT3since2000
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    Lightbulb “ExoDx” – Impressive New Urine Test for Biopsy Decision Making!

    I just became a aware of a “new” FDA approved urine test to aid in the decision whether or not a man needs a biopsy when he has a PSA in the 2 to 10 range. Recently we have had the benefit of a handful of tests that can shed light on this issue, in the context of PSA, perhaps free-PSA, DRE results, and other clinical information. This new test is aimed at determining whether there is significant cancer, meaning, here, cancer that has a Gleason score of 7 or higher, or below 7. It is called “ExoDx” because it examines “exosomes” in the urine to DX (diagnose, here aid diagnosis) of higher Gleason score prostate cancer. Exosomes are nano sized particles excreted by normal and cancerous cells that carry genetic information. Any easy way of thinking of them, at least to me, is that they are the equivalent of cellular dandruff. (Maybe someone can comment on the relevance of that analogy.) The ExoDx test is being referred to as one of the new “liquid biopsies”, though it does not substitute for a biopsy.

    On Wednesday evening I viewed a webinar sponsored by the National Alliance of State Prostate Cancer Coalitions (NASPCC) ON THE ExoDX test. The presenter was a very well-known urologic oncologist and prolific researcher, Dr. Judd Moul, MD, a now retired colonel and originally with the Army’s Walter Reed urology clinic back when I first knew of his work in 2000 but at Duke University since 2004. As an indication of his amazing productivity as a researcher, a search of www.pubmed.gov today for - moul jw [au] AND prostate cancer – yielded a list of 389 published medical research papers! Quite astounding! The whole webinar recording, 1 hour and 8 minutes long, is available via https://naspcc.org/index.php/resources/webinar-archives after a quick name and email registration.


    The FDA gave the test its Breakthrough designation, indicating approval, in June of 2019, so this is quite recent. The Breakthrough designation is given to drugs satisfying an unmet medical need.


    Unlike at least one other formerly used urine test, the ExoDx test does not involve a prostate massage. It is simply a matter of collecting urine in a kit, done in the doctor’s office or even at home, and sending the kit for analysis.


    The accuracy of the test is impressive, using a cut-off score of 15.6 (out of 100) below which risk of significant prostate cancer is quite low, pointing the doctor and patient away from a biopsy, and above which risk is increasingly elevated, suggesting that a biopsy is warranted. For those interested in detail, in one trial the “sensitivity” of the test, meaning ability to detect prostate cancer if it is there, was 92% and the “negative predictive value”, basically the percentage of negative results that are true, rather than either true plus false negatives, was 91.3%. Both are very impressive figures, and the pairing of such high figures is most unusual for tests for prostate cancer. A number of papers have been published about the test, based on at least two clinical trials that served as the basis for the FDA’s approval. They are well described and cited, with graphics, in the webinar.

    I would like to know more about how this new test adds independent value to other fairly recent tests for patients who are trying to decide whether to have a biopsy.

    I hope to post more about this new test in the near future, but am interested whether any of our Board readers has had it done. My impression from the presentation is that Medicare coverage is good but that not all private insurers will cover it at this time.

    Based on the webinar, which we can all view, I (or others of us) can answer some questions about the ExoDx test.

    ….Jim

    - - - - - - - - - - - - - - - - - - - - - - - -
    Diagnosis Dec 1999 PSA 113.6 (first ever), age 56
    Gleason 4+3=7 (J. Epstein, JHU), all cores +, most 100%; "rock hard" prostate with ECE - stage 3, PNI, PSADT determined later 3-4 months; technetium bone scan and CT scan negative; prognosis 5 years.
    Later ProstaScint scan negative except for one suspicious small area in an unlikely location. ADT Lupron as first therapy, in Dec 1999, then + Casodex in March 2000, then + Proscar and Fosamax in Sep 2000. Rejected for surgery January 2000; offered radiation but told success odds were low; switched to ADT only vice radiation in May 2000, betting on holding the fort for improved technology; PSA gradual decline to <0.01 May 2002. Commenced intermittent ADT3 (IADT3) with first vacation from Lupron & Casodex. Negative advanced scans in 2011 (NaF18 PET/CT for bone) and 2012 (Feraheme USPIO for nodes and soft tissue). With improved technology, tried TomoTherapy RT, 39 sessions, in early 2013, plus ADT 3 in support for 18 months (fourth round of IADT3), ended April 2014. Continuing with Avodart as anti-recurrence shield. Current PSA remarkably low and stable at <0.01; apparently cured. (Current T 99 6/5/20.) Supportive diet/nutrition, exercise, supportive medications during this journey, as well as switches in antiandrogen, 5-ARI, and bone drugs.

     
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    Old 07-31-2020, 07:25 PM   #2
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    Re: “ExoDx” – Impressive New Urine Test for Biopsy Decision Making!

    Jim,

    On Wednesday night, I joined the AnCam/USToo/Zero seminar on Active Surveillance featuring Dr. Peter Carroll, who started an AS program at UCSF way back in 1990. Very interesting, and he is always looking forward.

    Dr. Carroll wants to eliminate biopsies, that is a goal that all AS men share. He showed some slides about the prospects for blood and urine liquid biopsies, which he described as 98 percent accurate in detecting significant cancer. Being an AS pioneer, he is not interested in biopsying men with low grade PCa.

    The webinar and slides are online. Let me know if anyone wants the link.
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    Six biopsies from 2009 to 2019. Three were were positive with 5% Gleason(3+3) found.

     
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    Old 08-01-2020, 05:27 AM   #3
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    Re: “ExoDx” – Impressive New Urine Test for Biopsy Decision Making!

    Yes, I would like the link. Thanks.

    Both Dr. Peter Carroll (don't know how he had time to coach the Seahawks and also do all that medical work) and Dr. Matthew Cooperberg of UCSF have spoken about that UCSF active surveillance program at the series of annual conferences on prostate cancer that is given in Los Angeles, sponsored by PCRI. I haven't seen the schedule of speakers yet, but it's likely there will be a speaker on AS, and it could be one of these two doctors.

    Jim

     
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    Old 08-01-2020, 06:04 AM   #4
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    Re: “ExoDx” – Impressive New Urine Test for Biopsy Decision Making!

    Quote:
    Originally Posted by IADT3since2000 View Post
    Yes, I would like the link. Thanks.

    Both Dr. Peter Carroll (don't know how he had time to coach the Seahawks and also do all that medical work) and Dr. Matthew Cooperberg of UCSF have spoken about that UCSF active surveillance program at the series of annual conferences on prostate cancer that is given in Los Angeles, sponsored by PCRI. I haven't seen the schedule of speakers yet, but it's likely there will be a speaker on AS, and it could be one of these two doctors.

    Jim
    Here's the link:

    https://ancan.org/event/active-surveillance-prostate-cancer-webinar-series-1-dr-peter-carroll-as-beyond/
    __________________
    In Active Surveillance program at Johns Hopkins since July 2009.

    Six biopsies from 2009 to 2019. Three were were positive with 5% Gleason(3+3) found.

     
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    IADT3since2000 (08-02-2020)
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