Prostate specific antigen (PSA)‐based screening

‘The Japanese Urological Association guidelines on prostate specific antigen (PSA)-based screening for prostate cancer and ongoing cluster cohort study in Japan’ is published on pages 763–768 in the present issue of International Journal of Urology. Currently, there is controversy surrounding PSA-based screening in clinical practice. In order to widely discuss PSA-based screening, this Editorial was planned. In the first section, summaries of the five most recent articles on prostate cancer screening in International Journal of Urology are introduced. The second section is ‘AUA-JUA joint statement on screening for prostate cancer’ accompanied by an additional comment from Professor Robert C Flanigan (Loyola University Stritch School of Medicine, Chicago, IL, USA). The third section has been published as an Appendix in the Japanese Urological Association guidelines on screening for prostate cancer. The answers and opinions follow as Guest Editorials. International Journal of Urology is inviting submissions in response to any part of this Editorial, including views that oppose this Editorial. You are invited to submit Letters to the Editor by 31 January 2009. Please submit at: http://mc.manuscriptcentral.com/iju. Hiroyoshi Suzuki md Deputy Editor Lower urinary tract symptoms and risk of prostate cancer in Japanese men Matsubara A, Yasumoto H, Teishima J, Seki M, Mita K, Hasegawa Y, Yoshino T, Kato M, Usui TDepartment of Urology, Hiroshima University Graduate School of Biomedical Science, Hiroshima, Japan Matsubara et al. investigated whether or not men, in the Japanese population, with lower urinary tract symptoms are at increased risk of prostate cancer. Symptomatic Japanese men are not at higher risk of prostate cancer despite their higher prostate-specific antigen values compared with asymptomatic men of the same age group.1 (Int. J. Urol. 2006; 13: 1098–102) Willingness to pay for mass screening for prostate cancer: A contingent valuation survey Yasunaga HDepartment of Health Management and Policy, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan In an internet questionnaire survey by Yasunaga et al., 400 men aged 50–59 years in Japan were randomly split into two groups: the ill-informed group (n = 207), which was provided with information about the detection rate, and the well-informed group (n = 193), which was given additional information about false positive/negative results, latent cancer, and the yet-to-be-demonstrated mortality-reducing effect of the test. The mean willingness to pay was yen 1670 ($15.2). Giving sufficient information would not decrease willingness to pay for prostate-specific antigen screening.2 (Int. J. Urol. 2008; 15: 102–5) Ten year trend in prostate cancer screening with high prostate-specific antigen exposure rate in Japan Okihara K, Kitamura K, Okada K, Mikami K, Ukimura O, Miki TDepartment of Urology, Kyoto Prefectural University of Medicine, Kyoto, Japan Okihara et al. evaluated the tendency of the results and quality control of prostate cancer screening serially performed for 10 years in an area of Japan. Clinically localized prostate cancer increased by 17%, and locally advanced and metastatic cancers decreased by 12% in the second compared with the first 5 years of the 10-year period. Serial prostate cancer screening showed a tendency of stage migration in the screened cancer patients.3 (Int. J. Urol. 2008; 15: 156–60) Economic evaluation of prostate cancer screening with prostate-specific antigen Imamura T, Yasunaga HDepartment of Public Health Policy, Nara Medical University, Nara, Japan Economic issues cannot be ignored in conducting prostate cancer screening using prostate-specific antigen (PSA). Through an electronic search, Imamura et al. reviewed five descriptive cost studies and nine cost-effectiveness/cost-utility analyses concerning PSA screening. Most of the existing evidence was based on mathematical model analysis and the results are enormously disparate. At present, patients should be thoroughly informed of the limitations of PSA screening and, in consultation with urological specialists, make the personal decision of whether to receive it.4 (Int. J. Urol. 2008; 15: 285–8) Development of a new nomogram for predicting the probability of a positive initial prostate biopsy in Japanese patients with serum PSA levels less than 10 ng/mL Kawamura K, Suzuki H, Kamiya N, Imamoto T, Yano M, Miura J, Shimbo M, Suzuki N, Nakatsu H, Ichikawa TDepartment of Urology, Chiba University Graduate School of Medicine, Chiba, Japan Kawamura et al. developed a predictive model for Japanese males with a prostate-specific antigen (PSA) < 10 ng/mL to guide decision-making for prostate biopsies in order to provide more precise risk-analysis information for individual patients. Age and the independent predictors of a positive biopsy result (elevated PSA, decreased free to total PSA ratio, small prostate volume, and abnormal digital rectal examination findings) were used to develop a predictive nomogram based on 1037 Japanese patients' data.5 (Int. J. Urol. 2008; 15: 598–62) Fig. 1 AUA-JUA joint statement on screening for prostate cancer (20 June 2007). In the United States, we have seen a decline in prostate cancer mortality that has occurred after the use of PSA screening became more widespread. The factors for this decline in mortality remain undefined but many experts believe that PSA screening with earlier detection of prostate cancer at a lower stage has been a major contributing factor. There has also simultaneously been a shift in our use of PSA, including lower threshold levels for young patients, the use of isoforms of PSA and PSA kinetics. I personally put a great deal of stock in the findings of the Tyrol Prostate Program of Austria that has suggested that PSA screened men are less likely to be under-diagnosed and less likely to have extra-prostatic disease. Therefore, I personally continue to advocate yearly PSA screening (along with digital rectal examination) for men beginning at age 50 years and ending at 75 years (I begin earlier in men at increased risk of disease, including those with a positive family history or in African American men). The formal proof of this practice awaits the results of large screening studies, but in the interim I believe that this practice is very justifiable. Robert C Flanigan md PresidentAmerican Urological Association Question: Is it acceptable to conduct a population-based screening for prostate cancer based on a well-balanced fact sheet including updated reviews on screening, diagnostic procedure and treatment for prostate cancer? Akihiko Okuyama md Editor-in-Chief Comment from Professor Fernand Labrie MD Fernand Labrie, md phd oc oq Director of Research l'Université Laval (CHUL)Québec, Canada[email protected] In response to your question ‘Is it acceptable to conduct a population-based screening for prostate cancer based on a well-balanced fact sheet including updated reviews on screening, diagnostic procedures and treatment for prostate cancer?’ The answer is YES. Since metastatic prostate cancer is and will remain for a long time non curable, it is essential, in order to decrease deaths from prostate cancer, to diagnose the cancer at the localised stage when cure is a possibility in the majority of cases. With this well known scientific evidence that early diagnosis is a necessity, it remains important to explain to the patient the precision of the available diagnostic procedures (including detection of some cases of slow – growing cancer) and also the efficacy and side effects of the various treatments available for prostate cancer. It most also be clearly stated to the patient that the important reduction of the death rate from prostate cancer observed during the last of 15 years is due to early diagnosis coupled with efficient treatment while no cure exists for metastatic disease found in most cases if no screening is performed. The patient must decide between a small percentage of cases with potential overtreatment compared to the large number of lives saved with early diagnosis and appropriate treatment. It thus remains to the patient well informed by his physician and otherwise to decide to be screened or not to be screened but the answer is very clear for me: it is YES for annual screening with PSA followed by other techniques if abnormal PSA. Comment from Professor Francesco Montorsi MD Francesco Montorsi, md phdDepartment of UrologyVita-Salute San Raffaele UniversityMilan, Italy[email protected] The EAU are producing a guideline on prostate cancer for publication in 2009; ‘Screening and early detection’. Population or mass screening is defined as the examination of asymptomatic men (at risk). Usually, screening takes place within the framework of a trial or study and is initiated by a screener. Contrary to that, early detection or opportunistic screening represents individual case findings. It is initiated by the screenee (patient) and/or his physician. The primary endpoint of both is two-fold: first, the reduction of CaP-specific mortality. The goal is not to detect more and more carcinomas, nor is survival the endpoint because survival is heavily influenced by lead-time. Second, quality of life is important as expressed by quality of life adjusted gain in life years (QUALY). The trends in mortality from CaP show a wide variety from country to country all over the industrialized world. A decrease in mortality rates due to Cap is currently seen in the USA and Austria, but also in the UK and France, which share a similar decrease in CaP mortality rates. Similarly, in Sweden, the relative 5-year survival rates increased in the period from 1960 to 1988, which was attributed to increased diagnostic activities and the detection of more non-lethal tumours. However, this trend could not be confirmed in a similar study from the Netherlands. The reduction in mortality seen lately in the USA is often attributed to the widely adopted aggressive screening policy. However, there is still no absolute proof that the concept of prostate-specific antigen (PSA) screening is the cause for reduced mortality due to CaP. A non-randomized screening project in Tyrol (Austria) may support the hypothesis that screening can be effective in reducing CaP mortality. The early detection programme in combination with the availability of free treatment was used as an explanation for the 33% decrease in the CaP mortality rate seen in Tyrol as compared with the rest of Austria (level of evidence: 2b). In addition, Labrie and co-workers from Quebec (Canada) claim lower mortality rates in men randomized to active CaP screening, even though these results have been challenged. Other studies have contradicted the positive findings attributed to screening, with a comparative study between the Seattle area (highly screened population) and Connecticut (seldom screened population) by Lu-Yao and co-workers showing that, notwithstanding the very large diversity in PSA testing and in use of curative treatments, there was no difference in the reduction in the rate of CaP mortality (level of evidence: 2b). In order to be able to really evaluate the efficacy of CaP screening, prospective, preferably population-based, randomized trials are needed. Two large trials are underway, the PLCO (Prostate, Lung, Colorectal and Ovary) trial in the USA and the ERSPC (European Randomized Screening for Prostate Cancer) in Europe. The first analysis of the main endpoint of these trials-differences in CaP mortality is scheduled for 2008 (level of evidence: 1b). Thus, at the present time, there is a lack of evidence to support or disregard widely adopted, population-based screening programmes for early detection of CaP aimed at all men in a given population (level of evidence: 3). Less controversial, and recommended in most guidelines, is the use of PSA in combination with digital rectal examination (DRE) as an aid to early diagnosis (11) (see chapter 5) (level of evidence: 3). The group has also produced a shorter version for publication in European Urology (Eur. Urol. 2008; 53: 68–80). Comment from Professor Robert C Flanigan MD Robert C Flanigan, md Department of UrologyLoyola University Stritch School of MedicineChicago, Illinois, USA[email protected] I am very pleased to support the concept that it is acceptable to conduct a population – based screening for prostate cancer based on a well – balanced fact sheet including updated reviews on screening, diagnostic procedures and treatment for prostate cancer. Prostate cancer remains a major killer of men across the world. It is clear to me that early detection of this disease has led to the decreased death rate from prostate cancer that we have been experiencing in our country over the past several years. I am therefore personally very happy to support this proposed effort. I will send this note to you on my stationery. Comment from Professor Kenneth Lin MD Kenneth Lin, md faafp Medical Officer Center for Primary Care, Prevention and Clinical PartnershipsAgency for Healthcare Research and QualityRockville, Maryland, USA[email protected] Prostate cancer is the most common non-skin cancer in men in the United States; 1 in 6 men will be diagnosed during their lifetimes. However, the vast majority of men diagnosed with prostate cancer (218 890 in the US in 2007) do not die from it (27 350 deaths in 2006).6,7 These statistics suggest that our current methods for detecting prostate cancer that is clinically important (e.g. with the potential to cause health problems during a patient's lifetime) leave much to be desired. Prostate-specific antigen (PSA) screening in men over the age of 50 has been the norm in the United States since the early 1990s. PSA screening is also one of the few preventive benefits paid for by the US Medicare program for patients aged 65 and older, despite the lack of evidence from randomized trials showing that such screening reduces prostate cancer mortality8 and ample evidence that screening and treatment lead to significant psychological and physical harms.9–11 Why is this so? Ransohoff et al. have suggested that prostate cancer screening is ‘a system without negative feedback’; patients are likely to be grateful for early detection and rationalize adverse effects from treatment.12 A recent case report in the New England Journal of Medicine13 regarding a 54 year-old man with early-stage prostate cancer that was detected after multiple PSA tests and benign biopsies illustrated two points: (i) the harder you look for prostate cancer, the more you will find; and (ii) once confronted with a prostate cancer diagnosis, virtually all men in reasonably good health will choose invasive therapy. Given these realities, it is vitally important for a man to have an informed discussion with his physician about the potential benefits and known harms of PSA testing before deciding whether or not to get the test. Shared decision-making is recommended by most major US medical organizations, including the US Preventive Services Task Force (USPSTF).14 Many decision aids to assist shared decision-making about prostate cancer screening have been developed and have been shown to improve patient knowledge and involvement in the decision.15 Unfortunately, recent studies show that few physicians and patients are actually having these discussions, for a variety of reasons.16 The question posed to me was whether or not it was ‘acceptable to conduct population-based screening for prostate cancer based on a well-balanced fact sheet.’ I would argue that is not possible to create such a balanced fact sheet until we know more of the facts. The first critical question which will hopefully be answered within the next few years by two ongoing randomized trials,17,18 is whether population-based screening actually reduces prostate cancer mortality. If it does, the next questions will be which men benefit the most from screening, how often should screening be performed, and for how long? Many years (and quite possibly decades) of additional research will be required to answer these questions. In the meantime, there are many other preventive measures that clinicians should be recommending to men over 50 that have much stronger evidence of benefit, such as colorectal cancer screening, smoking cessation counseling, and yearly influenza vaccination. Better to spend one's time at an office visit discussing things that we know help before doing what might help. The opinions expressed in this commentary are those of the author and do not represent the official position of the Agency for Healthcare Research and Quality or the US Department of Health and Human Services. Comment from Professor William J Catalona MD William J Catalona, md Director Clinical Prostate Cancer ProgramRobert H Lurie Comprehensive Cancer CenterNorthwestern University Feinberg School of MedicineChicago, IL, USA[email protected] The informed use of PSA and PSA kinetics, with appropriate and effective can and death from prostate cancer. Since there has been a decline in United States prostate cancer mortality a reduction that I believe must be at in to early detection screening with effective treatment. A PSA a risk about the and of prostate cancer. The serum PSA with PSA with the and with mortality after treatment. If a man has a PSA of to there is a to prostate cancer will be found on on the number of biopsy risk to to if the PSA is to 10 and if the PSA is than studies show that the PSA for men in their and can prostate cancer and prostate cancer mortality. is less is prostate cancer risk using as a the PSA for the age group in the In my PSA study that years and men in their and of and in their PSA values of and in their of these are lower than the PSA suggested for recommending biopsy men in their as the PSA over the to there is a risk will develop prostate cancer over the next years. The risk to if the PSA is between and and to if the PSA is than men in the and as PSA values the for their age the risk of diagnosed with prostate cancer and for having aggressive prostate cancer also In findings of my PSA similar to those of the Prostate Cancer Prevention showed that in men with a PSA of less than and a digital rectal there was a in the percentage prostate cancer found on = biopsy as their PSA values from to from to from 1 to from to and from to to for high cancer, when the PSA was of cancers detected a high when it increased the percentage that were high to more than there is a of prostate cancer in men have PSA values of less than for cure the most important of PSA screening, in my personal of more than men with many is that if cancer was detected at a of to the cure rate is to if diagnosis occurred at factors can PSA rectal and in a PSA which can by to over two but for for are PSA and the percentage of free PSA. If the PSA is over it is for cancer and PSA also to volume, PSA and Similarly, if the percentage of free PSA is less than there is a the man has prostate the percentage of free PSA is than there is an the patient has prostate cancer. for PSA kinetics, PSA – which is the absolute in PSA year – is a for men have not been diagnosed with prostate cancer, because it is independent of the PSA. PSA time is also used for diagnosis and but since it is a of the PSA, the higher the the it takes for to two patients develop prostate cancers that for a A with a PSA of 1 ng/mL not have while patient with a PSA of ng/mL At the of one patient PSA has from 1 to for a and a PSA of has has to 5 from a of for the same PSA of time, is because it will years to from to if it at the same The diagnostic is that patient A might be to have a less aggressive and patient a more aggressive based their PSA PSA I for initial diagnosis, while time is for men have because patients have or with very after treatment – or – the PSA is not critical in the The PSA for man with no prostate cancer is for an of about one of a In a we found that if PSA increased by in the year before diagnosis, it was with a higher rate of mortality compared with lower PSA The PSA for prostate cancer is which there is an increased risk of prostate cancer mortality. There is as no proof from randomized clinical trials that PSA screening There are two trials in the United States and but the results will not be available for several years. both of these trials have significant and it is that will answer this question The population-based evidence for the of PSA screening to from a study of cancer more than of the US study in more than of the the between the of PSA-based screening, the of prostate cancer at diagnosis, and prostate mortality rates in the The results showed that the more PSA screening was the lower the of cases with disease at diagnosis, and the lower the prostate mortality rate in the The benefits of PSA-based screening in the US are also in the In the PSA screening was in there has been a reduction in the percentage of men with at time of in has a on the survival rate, which is for patients with or disease. There has been a reduction in the US prostate cancer mortality rate the trends are In PSA screening is such as France, the prostate cancer mortality has The of Tyrol has seen a decrease in deaths with PSA screening. In such as and Sweden, screening is not recommended for from to prostate cancer mortality is on the have been about whether PSA screening clinically However, prostate cancer deaths would not have decreased much if screening prostate cancer. The current for prostate cancer screening by US medical are The American Urological the American Cancer and the Comprehensive Cancer all that screening be to men over the age of 50 years with a life of at 10 and at a age in In the American of and the US Preventive Services Task Force do not believe there is sufficient evidence at this time to screening. The Cancer has on this the results of the screening current for prostate cancer screening PSA testing at age to provide a from which to over time and to appropriate risk the of the PSA you use – or Health PSA is more than lower if the is used (e.g. PSA = risk by their PSA values with the for their age group prostate biopsy if PSA is higher than ng/mL PSA and percentage of free PSA to evaluate from with and/or by PSA show that can after therapy. a PSA of to more aggressive is with an increased risk of death 15 years I would that prostate cancer death rates could be reduced by with the use of PSA with effective treatment. Comment from Professor MD and of protected] The controversy surrounding screening for prostate cancer with PSA PSA clinically significant prostate cancer in the majority of aggressive with or the in men diagnosed with clinically significant diagnosis and treatment of quality of The of prostate cancer to have been in the may be due in part by the fact that much of the have been from men, in is a because of their life In men, are most likely to benefit from early diagnosis and the for are much less a recent study has shown that even men over 65 years of age have a mortality benefit from treatment with or In the Tyrol in which the mean age of screened men was less than 65 the of to the of was the in the for of stage in the Tyrol was in the PSA of ng/mL to ng/mL and in the PSA of ng/mL to 10 In screening using the for than of men treatment for prostate reduction in prostate cancer mortality rates is it is also to the effects of prostate cancer screening and treatment on patient quality of in survival could be more than in quality of life that may result from diagnosis and suggest that to of the in mortality rates may to in to medical A of this study is that patients in Tyrol have to all and and that diagnosis and are free of for in prostate cancer mortality rates may be the to the of prostate cancer screening. can slow the of prostate cancer, as a curative treatment for advanced disease is not available any reduction in mortality is likely at in to that detect prostate cancer at an early stage and the the Since PSA screening was widely in prostate cancer mortality in the United States has decreased The prostate cancer mortality rate has decreased by an of yearly from to and the age prostate cancer mortality rate in the United States has decreased by an of In Austria, the decline was year while in the Tyrol it was The shift of stage in the PSA followed by effective should into a decrease of mortality. from the Tyrol have been using the same as in the for the of of our study findings. These findings continue to be with the that PSA testing and wide by men in the population, is with a reduction in prostate cancer mortality in a curative prostate cancer treatment are available free of to all patients. it is not possible from the available to the individual of PSA testing and curative treatment to the the more decline in mortality rates in Tyrol compared to the rest of Austria is to be The between early detection and treatment beginning in in and the decline in mortality in the age which in is with that seen in other screening with high It is likely that much of this decline in mortality rates is due to earlier detection and treatment of prostate cancer. However, an important of our study is that screening is the first in the of prostate cancer patients.

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