Earlier this year, at the annual Genitourinary Cancer symposium in San Francisco, we were first given information about the potential of three new tests for the diagnosis of prostate cancer: the so-called miR Sentinel tests from miR Scientific. Frankly, the results were so astonishing that we have waited to see the full details of the published data before we reported these, but the full, peer-reviewed results from the major trial of these tests have now been reported by Wang et al. in the Journal of Urology. The entire paper is available for anyone to read on line, and see also this media release issued by miR Scientific.
There are three of these Sentinel tests, and all three tests are based on the analysis of small noncoding RNA molecules (sncRNA) isolated from urinary exosomes in urine samples that are taken without the need for prior digital rectal manipulation. In other words, all that is needed from the patient is a simple urine sample. The tests are:
- The miR Sentinel™ PCa Test, which classifies men with prostate cancer from men with no evidence of prostate cancer
- The miR Sentinel CS Test, which stratifies men with prostate cancer between those with low-risk disease (Grade Group 1)and those with intermediate- and high-risk disease (Grade Group 2-5)
- The miR Sentinel HG Test, which stratifies men with prostate cancer between those with low- and favorable intermediate-risk prostate cancer (Grade Group 1 or 2) and those with high-risk (Grade Group 3-5) disease
But what is critical for the future of the accurate diagnosis of prostate cancer is the high degree of specificity and sensitivity of these three tests.
Based on data from a study of 1,436 subjects, it has been show that:
- The miR Sentinel PCa Test had a sensitivity of 94 percent and a specificity of 92 percent for prediction of the presence/absence of prostate cancer.
- The miR Sentinel CS Test had a sensitivity of 93 percent and a specificity of 90 percent for prediction of the presence of prostate cancer of Grade Group 2 or higher.
- The miR Sentinel HG Test had a sensitivity of 94 percent and a specificity of 96 percent for the prediction of the presence of prostate cancer of Grade Group 3 or higher.
The authors conclude, bluntly, that:
The Sentinel PCa, CS and HG Tests demonstrated high levels of sensitivity and specificity, highlighting the utility of interrogation of urinary exosomal sncRNAs for noninvasively diagnosing and classifying prostate cancer with high precision.
Frankly, these results, if confirmed over time — and they will need independent re-confirmation — are more accurate that biopsy results (when it is entirely possible to just miss a prostate cancer lesion entirely or to mis-read pathological data from the biopsy specimens). They thus raise real questions about whether biopsies may become unnecessary and irrelevant in the future diagnosis and management of prostate cancer (but that isn’t going to happen overnight).
It may well also be the case that these test can be more accurate for monitoring the effects of some types of treatment among men with prostate cancer over time. The one thing we can be quite sure about, though, is that they are not going to be as low in cost as a PSA test.
Now your sitemaster has not had prostate cancer; he has never been suspected of having prostate cancer; and he is now 72 years of age. What your sitemaster can tell you with absolute certainty, however, is that if he was to be suspected of the possibility of having prostate cancer from this point forward, he would move heaven and earth to see if he could have one or more of these tests before he ever subjected himself to a biopsy.
Use of these tests are expected to become commercially available in the very near future. They are not widely available as yet. However, …
We suspect that over the next 3 to 5 years there will be a lot more data forthcoming about the potential uses of these tests. For example, it looks as though these tests could be used easily — along with PSA testing — to confirm the appropriateness of active surveillance for the management of men with low- and favorable intermediate-risk prostate cancer. This might eliminate the need for regular MRI scans and/or biopsies.
Filed under: Diagnosis, Risk | Tagged: Diagnosis, exome, miR, sentinel, test, urine |
THE "NEW" PROSTATE CANCER INFOLINK 
If these results continue to be typical for this test it truly will be ground-breaking for early diagnosis of prostate cancer. Thanks for this post!
You wrote: “Frankly, these results, if confirmed over time — and they will need independent re-confirmation — are more accurate than biopsy results (when it is entirely possible to just miss a prostate cancer lesion entirely or to mis-read pathological data from the biopsy specimens). They thus raise real questions about whether biopsies may become unnecessary and irrelevant in the future diagnosis and management of prostate cancer (but that isn’t going to happen overnight).”
They cannot yet know if they are more accurate than biopsy results because they were so far only compared to biopsy results as the gold standard for this study.
But, they say they are working on a retrospective analysis against prostatectomy specimens:
They wrote: “Therefore, it is plausible that in this case the apparent false-positive cases resulting from the Sentinel HG Test may in fact be those who harbor higher grade cancer missed on the systematic biopsy. An alternative explanation is that some of these represent actual false-positive test results. To further investigate this issue we are currently performing a large retrospective study comparing the Sentinel Scores with radical prostatectomy pathology.”
In addition to what Sitemaster and Allen pointed out about the new tests, I was struck by two other aspects.
The first is that the study stated that PSA levels were “not available”. That surprised me because PSA levels have traditionally been used to distinguish between low-, intermediate-, and high-risk prostate cancers, and I would have thought that some comparison to PSA levels and the test results would have been made. Second, I am wondering about the potential utility of the RNA markers to provide a better prognosis for advanced prostate cancer patients and more information which might help the patient decide which second generation and novel treatments should be pursued and in what sequence.
Regardless, I am encouraged by the advance in utilizing RNA. Thank you for the post.
Best regards,
Richard
I hope this urine test is everything that it promises.
Not only would it be useful in identifying men with the cancer de novo but also in the regular monitoring and response to treatments of those who do have prostate cancer.
This is a very good development. I was diagnosed back in 2012 with a Gleason 4 + 4. (How) will this new test determine the aggressiveness of the disease?
Chuck:
Basically it appears to be able to tell you up front (i.e., prior to a biopsy) that (a) you do or don’t have cancer at all and that (b) if you do have cancer it can be categorized as
— low risk (equivalent to Grade Group 1)
— favorable intermediate-risk (equivalent to Grade Group 2)
— unfavorable intermediate- or high-risk (equivalent to Grade Groups 3 to 5)
In many cases this may eliminate the need for a biopsy at all — assuming that (c) the test can be revalidated in another significant group of patients and then (d) it can also be tested prospectively over time and the results compared to data from pathological outcomes in men who have radical prostatectomies for treatment.
I’ve looked through the site to try and find an email address to contact the Sitemaster. Can you please direct me to page that has the contact details or can you please provide me with the email address? Thank you
As Charles McGill wrote, there is a dire need to monitor men post treatment, in particular men who have had radiation, where the PSA level can fluctuate. A more accurate test would be extremely valuable.
Gaby: You can contact the sitemaster at mike@pcainternational.org.
Amazing. I missed this due to a notification glitch. All I know is they missed a known lesion at my last biopsy (law of small numbers. No: it did NOT remit …) whereas the law of large numbers suggests the same would not happen in a urine test.