Bergman Et Al. Structured Care for Men Who Want to Get Tested for Prostate
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DEVELOPMENT OF CARE Structured care for men who want to get tested for prostate cancer FINDINGS FROM CAPIO S:T GÖRAN PROSTATE CANCER CENTER Authors: is that new diagnostics should be introduced within a In Sweden, 10,474 men were diagnosed with prostate can- Martin Bergman the framework of today’s financial resources, and that Specialist Physician cer in 2016. About 5% of men in Sweden can be ex- critical resources such as human resources, technical Marie Hjelm-Erikssona pected to die of prostate cancer as cause of death. [1] Senior Physician It has now been several years since Professor Jonas equipment and other infrastructure are not exceeded. Fredrik Jäderlinga c,e Hugosson and his colleagues in Gothenburg were able Here we describe our initial experience of using Senior Physician, to demonstrate that early diagnosis of prostate cancer in structured nurse-led diagnosis and the Stockholm3 test Medical Doctor the form of screening with the prostate-specific antigen in combination with MRI followed by targeted biopsies a Edvard Meurling (PSA) blood sample reduces the risk of dying of prostate for prostate cancer diagnosis. Senior Physician cancer and suffering from advanced metastatic disease Andreas Torstenssona The Capio S:t Göran Model for Prostate Can- Senior Physician, [2]. This is entirely in line with the findings of the major Medical Doctor European screening study ERSPC [3] but not with the cer Diagnosis Tobias Nordströmbd american PLCO study that was negative [4]. The Swed- Specialist Physician, ish National Board of Health and Welfare, which recent- The Capio S:t Göran hospital is located in central Medical Doctor ly made a comparison of all scientific literature, comes Stockholm and is mandated by the Stockholm Henrik Grönbergab to the conclusion that population-based screening with County Council to handle approximately 25% of Senior Physician PSA reduces mortality in prostate cancer. prostate cancer care in Stockholm, which is equiv- Professor alent to approximately 500 new prostate cancer Stockholm3 can improve diagnostic precision cases per year. In 2017, Capio S:t Göran Prostate a Prostate Cancer Center, Cancer Center was established with the aim to Surgery Clinic, Capio S:t Prostate cancer diagnosis has developed rapidly, Görans Sjukhus AB provide cost-effective prostate cancer diagnostics b Department for Medical and several diagnostic tools have been suggested to in- Epidemiology and Biosta- using new diagnostic methods and efficient and tistics (MEB), Karolinska crease the precision of finding prostate cancer requir- structured processes. Clinical research to improve Institutet ing treatment. c Department for Molecular prostate cancer diagnosis is an integral part of the Medicine and Surgery One example is the blood-based Stockholm3 test (MMK), Karolinska Institu- work at the Prostate Cancer Center. tet that uses a combination of clinical information, pro- d Based on published results from the Stockholm3 test Surgery and Urologic Clinic, tein levels and genetic information to identify signifi- Danderyds Sjukhus AB and MRI followed by targeted prostate biopsies [6.7], e Radiology Clinic, Karolinska cant prostate cancer. Another example is targeted pros- University Hospital, Solna we have chosen to establish a diagnostic chain struc- tate biopsies with magnetic resonance imaging (MRI) tured as follows (see Figure 1: Standardized care pro- that can identify the location of a possibly significant cess Capio S:t Göran Prostate Cancer Center): cancer. Both the Stockholm3 test and MRI followed Corresponding author 1. Men of relevant age (45-75 years) who have not by targeted prostate biopsies have proved to show very Henrik Grönberg previously been diagnosed with prostate cancer promising results [5,6]. A recently published study [email protected] and who request prostate cancer testing either con- with 532 Swedish and Norwegian men using both tact the Prostate Cancer Center or are referred from Stockholm3 and MRI shows that a combination of general practitioners. both further increases the precision. The Stockholm3 Conflicts of interest test accounted for about 2/3 and MRI for about 1/3 of 2. A nurse contacts the man by phone and asks ques- Henrik Grönberg holds patents the improvement [7]. tions for risk stratification and to identify men who related to the Stockholm3 blood do not benefit from a prostate cancer diagnosis. sample and may receive compensa- This means that fewer men need to undergo medi- tion in connection with the use Men who do not benefit from testing because of, for cal examinations (prostate biopsies or MRI) and also of the Stockholm3 test. The other example, high age or comorbidity, are discouraged authors have no conflicts of interest. entails a reduction in overdiagnoses in which men from testing. We have chosen not to offer prostate with a harmless tumor receive a cancer diagnosis. In cancer testing to men over 80 years to reduce the order to reduce the prostate cancer mortality, it is also known problem of over-testing among elderly men important that the sensitivity of finding men with sig- [8]. On this occasion, the man is also informed of nificant cancer with new diagnostics is at least as good the pros and cons of prostate cancer testing accord- as with today’s diagnostics. Another important aspect ing to the Swedish National Board of Health and 2 Läkartidningen; 115: FCDT DEVELOPMENT OF CARE Figure 1: Standardized care process Capio S:t Göran Prostate Cancer Center Capio S:t Göran Prostate Cancer Center Increased risk3 Increased risk3 Cancer requiring (Stockholm3 ≥ 11%) (PIRADS ≥ 3) treatment 3 Men who should Referral Stockholm test MRI scanner Targeted and Pathological Treatment have taken PSA as reflex when systematic assessment test in primary PSA≥1.5 ng biopsy care Phone / ml1 • Not previously diag- • Nurse calls patient, • MRI with abbreviated • 2-3 targeted fusion • Rapid pathology • Treatment with surgery, nosed males (45-75 records medical history, protocol (16 minutes) biopsies are taken with 3-7 days radiation, hormones or years) who want to informs on pros and without contrast against respective le- response time active monitoring cons of prostate cancer • Time for MRI, biopsy, sions identified by MRI take a prostate cancer testing and orders MDK and PAD notice is • Systematic complemen- test are referred to Stockholm3 test2 directly booked by the tary biopsies4 the Capio S:t Göran • Men who do not benefit nurse Prostate Cancer Center from prostate cancer from primary care testing due to age or co- morbidity are dissuaded from taking the test Low / normal Negative MRI result Benign biopsy result Stockholm3 Individual follow-up based on risk5 1) The Stockholm3 test is a reflex test. In practical terms, that means that a PSA test is performed first. If the PSA level is higher than or equal to 1.5 ng / ml, the Stockholm3 test is automatically performed without the patient having to provide additional blood samples. Reflex texting saves money within healthcare by analyzing only if necessary (in this case, if PSA is higher than 1.5 ng / ml). At the same time, reflex testing facilitates the procedure for the patient, who only needs to provide one blood sample. 2) In addition to the oral information, the corresponding information, including the Swedish National Board of Health and Welfare’s information sheet about the pros and cons of PSA sampling, is sent to the patient’s home address. 3) Increased risk means increased risk for treatment-requiring prostate cancer defined as Gleason Score ≥ 7. 4) Systemic biopsies have been taken in all patients with PI-RADS score ≥ 3. To reduce overdiagnosis, now only systematic biopsies are taken on men with PI-RADS score 4-5. 5) Men with Stockholm3 Risk Score <5% (low risk) are followed up after 6 years. Men with Stockholm3 Risk Score 6-10% (normal risk) are followed up after 2 years. Men with Stockholm3 Risk Score ≥ 11% and PI-RADS score 1-2 are followed up after 2 years. Men with Stockholm3 Risk Score ≥ 11%, PI-RADS score ≥ 3 and negative biopsy are followed up after 2 years. Welfare’s guidelines. In addition to the oral infor- MRI review, the findings are classified according mation, the corresponding information, including to PI-RADS v2 [9]. In cases of suspected changes the Swedish National Board of Health and Wel- (lesions with PI-RADS score ≥ 3), tissue sampling fare’s information informational sheet about the is offered with a combination of systematic and pros and cons of PSA sampling, is sent to the pa- targeted biopsies. In the startup, we have chosen to tient’s home address. perform both systematic and targeted biopsies on 3. The man receives a referral for a blood sampling all men with suspected changes. We have changed with the Stockholm3 test. Stockholm3 is a reflex this in spring 2018, and men with a PI-RADS score test performed if the PSA level is higher than 1.5 3 now only undergo targeted biopsies. This is done ng / ml that results in a risk score for a significant to reduce the risk of overdiagnosis of low risk can- prostate cancer (where significant prostate cancer cer. For men with a PI-RADS score 4-5 there is a is defined as Gleason Score ≥ 7 cancer). In practi- need for staging the entire prostate prior to surgery. cal terms, that means that a PSA test is performed Therefore, both targeted and systematic biopsies first. If the PSA level is higher than 1.5 ng / ml, the are performed on these men. Men with low or nor- Stockholm3 test is automatically performed with- mal risk in the Stockholm3 test or a negative MRI out the patient having to provide additional blood (PI-RADS score 1-2) are recommended to take a samples. Reflex texting saves money within health- new blood sample test in 6 and 2 years respectively.