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Let’s take a male patient, 58 years, whose father had prostate cancer diagnosed at the age of 78. Our patient has African American roots (which indicates an elevated relative risk), is 193cm tall and weights 95kg. The patient has also never done any screenings beforehand. With these information, we look at the following factors [1]:
As for such a person an elevated risk is indicated, our software would recommend the following screenings [2]:
As recent studies showed, the PSA level is a good indicator for growth of prostate cancer and can be monitored closely. Our software continuously checks the PSA level and evaluates, if there is rise of PSA level compared to the last PSA level test or certain levels are already reached and further examination are indicated. This monitoring feature ensures to catch early indications and enables further steps.
Our personalized risk algorithm groups patients into 3 groups:
based on the risk group, we recommend the following screenings:
This algorithm will also undergo a clinical check with urologists to confirm that our algorithm are appropriate and effective in detecting higher risks and recommending the correct screenings.
The test for PSA is not included within the scope of screenings for Public Health Insurance, but ongoing studies [3] are about to find enough evidence, that a population wide approach including the PSA level within the screening program is beneficial.
Our program neglects in some meanings the coverage of the Public Health Insurance in Germany and uses all available medical knowledge, including examination and screening procedures which are not always covered by Public Health Insurance, but are already recommended by national and international guidelines, like the European Association for Medical Oncology or the American Society of Clinical Oncology for patients at higher risk of developing cancer.
As we do a risk-assessment and show the medical need for further screenings for patients at higher risk and provide relevant evidence to the patient, we aim that primary physicians see the indication and are willing to prescribe the screenings.
For our patient, the German Public Health Insurance covers only the following examination:
The Digital rectal examination is since ever controversial due to its relatively low sensitivity and specificity as well as a low acceptance within the male population. [4]
With the presence of proper PSA level testing, a combination of those two screening methods will provide a higher security of catching prostate cancer early, and going into further diagnostic to specify, which steps have to be undertaken next.
Important to mention is the high psychological burden men have with a DRE, which can also be the reason having a low attendance of men for prostate screenings. Given the option to do a regular blood test for PSA can increase the acceptance of doing regular screenings.
For completeness, it also has to be mentioned that PSA level screening is not without risk, as it can come with false positive results which can lead to biopsies. In our program, we want to fully inform our patients so that an active, informed decision can be made to do a screening or not.
To dive more into the topic of regular PSA level screening and risk of wrong results, we address the problem of overdiagnosis and overtreatment with connecting and reviewing our patients screening results with our specialized physicians, who bring in their experience to identify whether a suspicious lesion can cause malignant cancer or will never develop as one. Therefore, patients have immediate consultation through Curie Science Center and gets the relevant information to do an informed decision about the next steps.
As our algorithm can also recommend screenings, which deviate from the coverage of Public Health Insurance, the question, who pays for the examination, arises. Besides that, we also include the screenings which are covered by Health Insurance.
Now, we can’t give you the answer you’d like to hear, that everything is paid by insurance, because this wouldn’t just be the reality – at the beginning. As written down in the guidelines, our recommendations are based on medical evidence as well as medical experience, therefore if we indicate an elevated or high risk for a patient, the indication to do extended examination is given. But it would be naive to believe that all of our recommended screenings would be covered by Public Health Insurance. So we expect, that at the beginning, in some cases even though enough evidence is given, some patient have to privately pay for doing our recommended examinations. To put this in numbers, e.g. related to our patient, a PSA test costs around 25€-35€ nowadays.
Finally, our big goal is, that our platform and algorithm can provide the relevant medical indication based on guidelines, medical evidence and clinical trials with a transparent and clear informative structure for the primary doctors to prescribe the extended screenings within the scope of Public Health Insurance.
Stay tuned for our next post in this series, where we'll look at the technical and medical challenges we face during our development of the platform.
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Sources:
[1] Harvard Report on Cancer Prevention Volume 4: Harvard Cancer Risk Index; Colditz G.A. et al. (2000)
[2] Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up; Parker C. et al. (2020)
[3] https://www.dkfz.de/de/Personalisierte-Frueherkennung-Prostatakarzinom/PROBASE/Einleitung.html; accessed 26.09.2023
[4] Digital Rectal Examination for Prostate Cancer Screening in Primary Care: A Systematic Review and Meta-Analysis; Naji L. et al. (2018)
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