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Abstract

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

The exposure rate of screening for prostate cancer using prostate-specific antigen (PSA) in Japan is still very low compared with that in the USA or Western Europe. The mortality rate of prostate cancer will increase in the future and in 2020 it will be 2.8 times higher than in 2000. Therefore, there is an urgent need to determine the best available countermeasures to decrease the rate of prostate cancer death.


Policy statement of the Japanese Urological Association on screening for prostate cancer

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

The Japanese Urological Association (JUA) recommends PSA screening for men aged 50 years or older. The recommendation is based on fact sheets indicating the present status and future perspectives on prostate cancer and the merits and demerits of screening for prostate cancer in Japan. The JUA provides the best available screening system for men who want to be screened.

Theoretical background of the policy statement

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References
  • 1
    The exposure rate of screening for prostate cancer using PSA in Japan is still very low compared with that in the USA or Western Europe. Therefore, about 30% of newly detected prostate cancer cases have bone metastases and many clinically significant cancer cases may be undetected and missed in Japan until they develop into clinically advanced disease. In the mean time, incidence rates of prostate cancer have increased and are estimated to increase in the future. The number of patients with newly diagnosed prostate cancer will be 78 468 in 2020, which will be the second highest male cancer following lung cancer.1 The mortality rate of prostate cancer will also increase in the future and in 2020 it will be 2.8 times higher than that in 2000.2 Therefore, there is an urgent need to determine the best available countermeasures to decrease the rate of prostate cancer death.
  • 2
    The Cancer Countermeasure Fundamental Law, one of the important national policies declared in 2007 stated the goal of a 20% decrease in the mortality rates of cancer in Japan within 10 years. The JUA recommends PSA screening based on well-balanced fact sheets in human dry-dock (Ningen dock) and also population-based screening for prostate cancer to contribute to achieving the goal in terms of reducing the mortality rate of prostate cancer, which has been shown in the USA since 1992.
  • 3
    The screening rate in the USA is about 75% among men aged 50 years or older. According to the latest cancer registry in the US, the mortality rate of prostate cancer has decreased since 1992, and in 2004 showed a 34% decrease compared with 1990.3 Because there is no effective preventive method for clinically manifested prostate cancer, the decreasing prostate cancer mortality demonstrated in the USA may be due to PSA-based screening and subsequent appropriate treatments for screen-detected prostate cancer.
  • 4
    According to the latest regional correlation study,4 there is a positive correlation between the incidence of metastatic prostate cancer and the mortality rate of prostate cancer. Furthermore, there is a negative correlation between the penetration of the PSA test and the incidence rate of prostate cancer. These findings may result in a negative correlation between the exposure rate of the PSA test and the mortality rate of prostate cancer.
  • 5
    Two large prospective randomized controlled trials (RCT) are now ongoing in the USA, named the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening study, and in Europe, named the European Randomized Study of Screening for Prostate Cancer (ERSPC). The latest report from the ERSPC section in Sweden indicated that the rate of advanced prostate cancer (which is defined as metastatic prostate cancer and prostate cancer with PSA levels above 100 ng/mL) showed a 49% decrease in the screening group compared with the control group.5 This study clearly showed the effectiveness of PSA screening in terms of reducing advanced prostate cancer. The prognosis of cases with advanced prostate cancer is significantly worse than that of early detected prostate cancer cases. Therefore, a decrease in the incidence rate of advanced prostate cancer may be a surrogate marker for a decrease in the mortality rate of prostate cancer.
  • 6
    The latest results in the Tyrol screening project demonstrated a 70% decrease in metastatic prostate cancer in the area following the introduction of free a PSA test, and the exposure rate was high at 86.6%.6 The mortality rate of prostate cancer in 2005 showed a 54% decrease compared with that expected. These results may be due to high exposure of PSA screening and subsequent appropriate treatment. The reliability of the Tyrol study is high because all statistical analyses have been carried out by a third party, the International Agency for Research on Cancer (IARC).
  • 7
    There are still controversies in the routine use of PSA screening for asymptomatic males over the age of 50. However, the point of controversy has changed with time to issues of overdetection, overtreatment and a decrease in quality of life (QOL) after treatment. However, these issues will be solved in the future with progress in active surveillance protocols and also in minimally-invasive prostate cancer treatment.
  • 8
    The American Urological Association7 (AUA) and the American Cancer Society8 (ACS) recommend screening for prostate cancer using PSA and digital rectal examination (DRE), based on well balanced fact sheets on screening for prostate cancer. The US preventive service task force (USPSTF), which has the most prudent attitude in the world, does not recommend routine use of the PSA test for asymptomatic men and proposes doing PSA screening after shared-informed decision-making between doctors and men who want to be screened.9 Therefore, the baseline consensus on PSA screening around the world is that doctors should show and discuss the fact sheets on PSA screening and prostate cancer. Then, doctors should provide the optimal screening system, including biopsy and treatment for men who want to be screened after reviewing the well-balanced fact sheets to facilitate shared-informed decision-making.
  • 9
    Recently, people's values have diversified, so, results from RCT showing a decrease in death from prostate cancer may not be the only acceptable scientific evidence for all men. If a man considers that having positive results in decreasing death from prostate cancer from ongoing RCT is very important, he should not undergo screening for prostate cancer at present. If a man considers that the Tyrol study, which demonstrated reliable results on decreasing mortality from prostate cancer, is important, he could be a candidate for PSA screening. If a man considers that a significant decrease in the incidence of metastatic prostate cancer is very important, he could be a candidate for prostate cancer screening. The number of men having the latter two opinions may be quite large, so, we must keep providing opportunities for PSA screening with the two main screening systems in Japan; the population-based screening and human dry-dock (Ningen dock).

Review of the literature on the pros and cons of PSA screening

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

The exposure rate of PSA screening in the USA is very high at about 75% of men aged 50 years or above. According to research on the trend in the mortality rate of prostate cancer based on the cancer registry in USA, the mortality rates of screening have continued to decrease since 1992 and showed a 34% decrease between 1990 and 2004.3 Because there is no effective primary prophylaxis to prevent the development of prostate cancer, the drastic decrease in the mortality rate of prostate cancer may be due to the high exposure rate of PSA screening and the subsequent appropriate treatment strategies in the USA. According to the most recent regional correlation study in the USA, there is a positive relationship between the incidence rate of distant metastases and mortality rate of prostate cancer and a negative relationship between PSA use and the incidence of distant metastases.4 In other words, PSA screening can decrease the incidence of distant disease, which may lead to decreases in death from prostate cancer. Two large prospective randomized controlled trials investigating the effect of PSA screening on mortality from prostate cancer are now ongoing in the USA and Europe. The most recent publications from the ERSPC section in Sweden demonstrated that the incidence of advanced prostate cancer cases, defined as metastatic prostate cancer and cancer with pretreatment PSA levels above 100 ng/mL, significantly decreased (49%) in the screening arm compared with the control arm.5 The prognosis of advanced prostate cancer is worse than that of cancer detected in the earlier stage. Therefore, the results can be evaluated as a high priority study in the field of screening for prostate cancer. According to the latest results in the Tyrol study, the exposure rate of screening was extremely high at 86.6% in 2005, and the incidence rate of metastatic prostate cancer showed a 70% decrease.6 In the meantime, the mortality rate of prostate cancer showed a drastic decrease at 54% compared with the expected mortality rate in the area. Because all analyses were carried out by a third institution, the International Agency for Research on Cancer (IARC), the reliability of the results is thought to be very high.

An observational study conducted in Japan demonstrated an effect of PSA- based screening on mortality reduction.10 Cause-specific survival in prostate cancer cases detected in PSA-based screening was significantly higher than in those detected in the screen system before introducing the PSA test. The 10-year relative survival rate in screen-detected prostate cancer cases was close to 100%, but that in non-screen-detected prostate cancer cases was significantly low at around 40% (P < 0.05). Lead-time bias should be taken into account for such an observational study; the most recent study demonstrated that the effect of lead-time bias on survival in screen-detected cancer was not very large.11 Although self-selection bias could not be eliminated from such an observational study, screening and subsequent appropriate treatment may be effective to improve cause-specific and relative survival. According to the other observational study in Japan, the proportion of metastatic prostate cancer cases in a specific area, where the exposure rate of screening between 1995 and 2004 was estimated to be high at 65%, was low at 8% between 1995 and 1999 and decreased to 3% between 2000 and 2004.12

Alternatively, the reliability of all time series research and regional correlation studies that denied or did not show a positive relationship between PSA screening and a decrease in the mortality rate of prostate cancer included serious flaws in their study protocols in terms of insufficient duration of follow-up and a small difference in the exposure rates of PSA screening among comparable regions.13–22

Informed consent in screening for prostate cancer

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

Screening for prostate cancer using the PSA test for asymptomatic men is still controversial in terms of effectiveness. However, all reliable studies revealed a positive correlation among PSA screening with a decreasing incidence of metastatic prostate cancer and also the mortality rate of prostate cancer. Therefore, the debatable points have shifted and will change from whether the PSA test decreases the mortality rate to the issue of overdiagnosis, overdetection and influence on QOL after various treatments for screen-detected prostate cancer. In the mean time, advances in minimally-invasive treatment for maintaining QOL for patients and development of active surveillance protocols may solve uncertainties and controversies regarding the negative effect of PSA screening. The present baseline recommendation on PSA screening is to conduct PSA-screening after shared-informed decision-making based on fact sheets indicating updated information on epidemiological features, and merits and demerits of screening and treatment. The JUA recommends providing fact sheets, including all important issues on prostate cancer, to men who want to be screened in the near future. Fact sheets should be divided into two stages, one for men before undergoing screening (Table 1) and the other one is for men after undergoing the PSA test (Table 2). The guideline on screening for prostate cancer edited by the JUA clearly indicates expected outcomes, including both positive and negative effects, on men undergoing PSA screening and also those on men not undergoing PSA screening.

Table 1.  Fact sheet on screening for prostate cancer for men before undergoing the prostate-specific antigen (PSA) test
For men before deciding whether or not to take the test for screening
About prostate cancer and the diagnostic modality/procedureBenefits and limitations of screening for prostate cancer
• The number of men that died from prostate cancer in 2006 is estimated to be around 10 000, which is the eighth-most lethal cancer in Japanese men. • It is estimated that the number of men with detected prostate cancer will increase and it will be the second highest male cancer following lung cancer in 2020. The number of deaths from prostate cancer in 2020 is estimated to be three times higher than that in 2000. • The risk of developing prostate cancer increases with age. In general, men aged 50 years or older are recommended to begin PSA screening. • The risk of developing prostate cancer may increase in men with a family history of prostate cancer, in which case it is recommended that screening begins from an earlier age (e.g. 40 or 45 years). • In Japan, men have a chance to undergo screening for prostate cancer in population-based screening conducted by local governments or a human dry-dock conducted mainly by screening centers in public or private hospitals. The screening modality is PSA in both a screening system and digital rectal examination (DRE) occasionally in human dry-dock. • In general, there are no specific symptoms in early stage prostate cancer. Therefore, it may be difficult to detect early stage prostate cancer without screening using the PSA test and/or DRE. • PSA is the best screening tool in terms of detecting prostate cancer in the early stage with a high sensitivity at 80–90%. The probability of prostate cancer increases with increasing PSA levels in serum. • About 8% of men screened may have PSA levels above the cutoffs and may need a prostate biopsy. Men with abnormal findings on a PSA test and DRE are recommended to undergo transrectal ultrasonography (TRUS)-guided prostate biopsy, which takes cores of prostate tissue using a fine needle. The number of biopsy cores is set between 6 and 12 on average at institutions in Japan, but occasionally it takes more than 12 cores in some institutions. • Prostate biopsy is carried out under local or lumbar anesthesia in outpatient or inpatient clinics. The operating time is about 15 min. • If a man undergoes prostate biopsy, prostate cancer is detected in about 40% of men. The detection rate is about 20% in men with a slight increase in PSA level, but that increases with higher PSA levels.• If screening for prostate cancer is not provided to the public, about 30% of men diagnosed with prostate cancer would have metastases. If a man undergoes screening for prostate cancer, the risk of detecting prostate cancer in the metastatic stage decreases. • Effect of PSA screening in terms of decreasing mortality is still uncertain in randomized controlled trials, which are now ongoing in the USA and Europe. The latest results in the Tyrol study, which is a well-controlled and reliable study, demonstrated about a 50% decrease in the mortality rate of prostate cancer in 2005 as compared with that expected without screening. • Although rare, 2–3% of prostate cancer cases cannot be detected in PSA screening because very poorly differentiated or undifferentiated prostate cancer cells do not secrete PSA. • Some biopsied men may have complications such as fever, rectal bleeding, hematuria and hematspermia, etc. However, severe complications such as high fever which needs hospitalization and septic shock are rare at 1.1% and 0.07%, respectively. • If a man undergoes a standard prostate biopsy, about 20–30% of prostate cancer is missed. Therefore, men with suspicious findings on PSA and/or DRE, but without prostate cancer on biopsy should be followed carefully. • If men with PSA levels below 10 ng/mL underwent prostate biopsy, prostate cancer would be detected in 20–40% of them and 60–80% of men would undergo unnecessary biopsy without detecting prostate cancer. However, the likelihood of unnecessary biopsy may decrease with higher PSA levels. • About 30–50% of men have latent insignificant prostate cancer throughout their lives. There is little possibility of detecting such insignificant prostate cancer within a screening system using PSA with or without DRE. • Screening for prostate cancer can detect many clinically significant prostate cancer cases within the curative stage. However, about 10% of screen-detected prostate cancer may be clinically insignificant, which is known as overdetection. However, the risk of overdetection decreases with higher PSA levels.
Table 2.  Fact sheet on screening for prostate cancer for men after knowing their own prostate-specific antigen (PSA) test results
For men after undergoing PSA screening
Correspondence according to individual PSA resultsMerits, demerits and uncertainties regarding biopsy and treatment
• Men with PSA levels of 1.0 ng/mL or lower may have a low risk of increased PSA above 4.0 ng/mL at 1.3% over 5 years of follow-up and should be screened every 3 years. • Men with PSA levels between 1.1 and 2.0 ng/mL may have a risk of increased PSA above 4.0 ng/mL at 7.5% over 5 years of follow-up and should be screened annually. • Men with PSA levels between 2.1 and 3.0 ng/mL may have a high risk of increased PSA above 4.0 ng/mL at 30% over 5 years of follow-up and are highly recommended to undergo annual screening. • Men with PSA levels between 3.1 and 4.0 ng/mL have a very high risk of increased PSA above 4.0 ng/mL at 62% over 5 years of follow-up and are highly recommended to undergo annual screening. • The cut-off of PSA for biopsy indication is set at 4.0 ng/mL in general. Alternative cut-offs are set in an age-specific manner (50–64 years; 3.0 ng/mL, 65–69 years; 3.5 ng/mL, 70 years or older; 4.0 ng/mL). • Men with abnormal findings on a PSA test and digital rectal examination (DRE) are recommended to undergo transrectal ultrasonography (TRUS)-guided prostate biopsy, which takes cores of prostate tissue using a fine needle. The number of biopsy cores is set between 6 and 12 on average at institutions in Japan, occasionally taking more than 12 cores in some institutions. • Men diagnosed with prostate cancer are recommended to check disease status by computed tomography (CT), magnetic resonance imaging (MRI), bone scan, DRE and TRUS. • Primary treatments for prostate cancer are active surveillance, radical prostatectomy, radiation therapy and hormonal therapy. • Patients with prostate cancer decide their treatment strategy after getting enough information on available treatments in terms of merits and adverse effects. It is also important to select the treatment according not only to their own disease status, but also to socioeconomic status, individual tolerability and future perspectives.• Some biopsied men may have complications such as fever, rectal bleeding, hematuria and hematspermia, etc. However, severe complications such as high fever, which needs hospitalization, and septic shock, may be rare at 1.1% and 0.07%, respectively. • If a man underwent standard prostate biopsy, prostate cancer would be missed in about 20–30% of them. Therefore, men with suspicious findings on PSA and/or DRE, but without prostate cancer on biopsy should be followed carefully. • If men with PSA levels below 10 ng/mL undergo prostate biopsy, prostate cancer would be detected in 20–40% of them and 60–80% of them would undergo unnecessary biopsy without detecting prostate cancer. However, the likelihood of unnecessary biopsy decreases with higher PSA levels. • About 30–50% of men have latent insignificant prostate cancer throughout their lives. There may be little possibility of detecting such an insignificant prostate cancer within a screening system using PSA with or without DRE. • Screening for prostate cancer can detect many clinically significant prostate cancer cases within the curative stage. Alternatively, about 10% of screen-detected prostate cancer may be clinically insignificant, which is known as overdetection. However, the risk of overdetection decreases with higher PSA levels. • Radical prostatectomy may give high curability if cancer is limited to the prostate. However, the likelihood of residual cancer may not be rare because there is a limitation with clinical staging before surgery. Major complications are erectile dysfunction and urinary incontinence, but the frequency of urinary incontinence is not so high at around 10%. If patients want to preserve sexual function, nerve-sparing radical prostatectomy may be one option. Mortality from the operation itself is very rare. • Treatment modalities for radiation therapy are varied, including external beam radiation therapy and brachytherapy. Recently, intensity modulated radiation therapy (IMRT), which improves the treatment efficacy and decreases adverse effects, has been made available in Japan. Another option is carbon ion beam and proton beam therapy, but there are only a few institutions offering the treatment. Indications for primary radiation therapy are localized and locally advanced prostate cancer. There may be a high curability even for patients with locally advanced prostate cancer in combination with radiation therapy and hormonal therapy. Major complications are radiation proctitis, prostatitis and urethritis. The risk of erectile dysfunction is about 20–40% of treated cases, but that may be lower than radical prostatectomy. • Hormonal therapy can be effective even for patients with metastatic disease. Treatment agents are monthly or 3-monthly luteinizing hormone-releasing hormone (LHRH) agonist injection, anti-androgen drugs and castration. LHRH agonists and castration may have equal efficacy. An LHRH agonist in combination with an anti-androgen may be an important treatment option. Estrogen agents are also used, especially for patients with disease recurrence after treatment with primary androgen deprivation therapy such as an LHRH agonist and castration. Alternative treatment options for hormonal therapy are combination therapy with surgery and radiation in neoadjuvant, adjuvant or salvage settings. Major complications of primary hormonal therapy are erectile dysfunction, loss of bone mineral density, hot flushes, sweating, and reduced muscle power. • Active surveillance may be an important treatment option, especially for older men, with small and low grade cancer. • There may be many men who survive prostate cancer without lowering their quality of life (QOL) after receiving appropriate treatment. However, some patients survive prostate cancer but have a resultant loss of QOL. Also, some patients may be overtreated without merits in terms of prolonging their lives.

Ideal screening system in Japan

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

Candidates for PSA screening are men aged 50 years or older in general and 40 or 45 years or older in men with a family history. The screening modality should be the PSA test for population-based screening for prostate cancer mainly concomitant with the basic health check-up system in Japan and PSA with or without DRE in human dry-dock (Ningen dock). Fact sheets including the merits and demerits of PSA screening should be provided to candidates before carrying out the screening test. The cut-off of PSA test for the biopsy indication is recommended at 4.0 ng/mL. Alternative cut-offs for the biopsy indications are age-specific reference ranges of PSA, which are set at 3.0, 3.5 and 4.0 ng/mL in the age ranges of under 65, 65–69 and 70 years or older, respectively.23 The optimal screening interval cannot be stated at present, but it is well-known that the risk of developing prostate cancer may strongly relate with baseline PSA levels. Therefore, it is reasonable to set the screening interval according to baseline PSA levels. One recommendation is to set the screening interval at once every 3 years for men with baseline PSA levels lower than 1.0 ng/mL and annually for men with baseline PSA levels between 1.0 ng/mL and the cut-offs.24–26

Systematic prostate biopsy must be carried out by transrectal ultrasonography guidance. The optimal number of biopsy cores is uncertain at present, but should be set at at least six cores. Recently, the usefulness of multiple-core biopsy has been demonstrated in many studies around the world. Therefore, a multiple-core biopsy, which takes around 12 cores, is an alternative option for prostate biopsy.

Merits and demerits of screening for prostate cancer

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

Merits for men who undergo screening for prostate cancer

  • 1
    Decrease in the incidence of metastatic prostate cancer.
  • 2
    Decrease in the mortality of prostate cancer is uncertain in ongoing RCT, but is certain in the latest results from the Tyrol study.
  • 3
    The probability of men being diagnosed with prostate cancer in the early stage increases if he decides to be screened. If men are diagnosed with prostate cancer in the early stage, they can be recommended various treatment strategies including radical prostatectomy, external beam radiation therapy, brachytherapy, hormonal therapy and active surveillance according to age, tumor grade, PSA level, clinical stage, social activity, economic issues and patient's preference, etc.

Demerits for men who undergo screening for prostate cancer

  • 1
    Increase in the risk of detecting clinically insignificant cancer. The percentage of insignificant prostate cancer in screen-detected prostate cancer was estimated at around 10% in Japanese males who participated in a prospective study on active surveillance.
  • 2
    Increase in likelihood of overtreatment. Risk of overtreatment may not decrease until establishment of a reliable active surveillance protocol.
  • 3
    Rare, but very high grade prostate cancer that does not secrete PSA may be missed in PSA screening.
  • 4
    About 60–80% of men with PSA above the cut-offs may undergo unnecessary biopsy, but the likelihood of undergoing unnecessary biopsy may decrease as PSA levels become higher.
  • 5
    According to the survey conducted by the JUA, about 15% of men biopsied may have complications including fever, rectal bleeding, hematuria and hematspermia, etc. The percentage of men with high fever above 38°C was rare at 1.1%, and those having severe complications such as septic shock were very rare at 0.07%.27

Merits for men who do not undergo screening

  • 1
    Significant decreased risk of overdetection and overtreatment.
  • 2
    Decreased risk of undergoing unnecessary biopsy.
  • 3
    Decreased risk of having anxiety about having prostate cancer, especially for men with false-positive PSA results.

Demerits for men who do not undergo screening

  • 1
    Increased risk of later detecting metastatic prostate cancer or advanced prostate cancer. If men are detected with prostate cancer in the advanced stage, the prognosis may be limited.
  • 2
    May miss the chance of decreasing the risk of death from prostate cancer, as already shown in the Tyrol study.
  • 3
    Difficulty in detecting prostate cancer in the early stage.

Baseline consensus on screening for prostate cancer

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

The AUA recommends PSA-based screening (with DRE) for prostate cancer to men aged 50 years or older and to men who have a life-expectancy of at least 10 years.8 Men with a high risk of developing prostate cancer (those with a family history of prostate cancer or African American men) are recommended to begin testing at an earlier age. Information should be provided to recipients about the benefits and limitations of PSA screening. Recently, the AUA and the JUA made a joint statement on screening for prostate cancer, which stated the above-mentioned policy. The ACS has almost the same policy7 as the JUA and the AUA.

The US Preventive Services Task Force (USPSTF) considers it vitally important for men to make informed decisions with their physicians about the potential benefits and known demerits of PSA testing before deciding whether or not to get the test (shared informed decision-making).9

Overall, almost all medical organizations have a policy that information on screening for prostate cancer, including the benefits and limitations of PSA screening, complications for biopsy and treatment etc. should be provided to recipients before taking the test. If a man wants to undergo the test, physicians should provide the best available screening system. A policy statement that PSA screening should be omitted and informed decision making is not necessary (i.e. D recommendation in the ranking proposed by USPSTF) is no more acceptable in either individual-based or population-based screening for prostate cancer at present.

Ongoing study on screening for prostate cancer in Japan

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References

Two large prospective randomized controlled trials, the Prostate, Lung, Colorectal and Ovarian (PLCO) cancer screening trial in the USA and ERSPC in Europe are now ongoing. However, contamination in control groups may be a serious problem. Also, the low exposure rate of screening in Japan may be a merit for a screening study in terms of lowering contamination in the control cohort. Therefore, a cluster prospective cohort study, the Japanese Prospective Cohort Study of Screening for Prostate Cancer (JPSPC), was conducted in order to evaluate the effectiveness of screening for prostate cancer in 2001 and has been ongoing since 2002. The primary endpoint of JPSPC is comparing changes in the mortality rate of prostate cancer between a screening cohort and a control cohort. JPSPC is a prospective cluster cohort study. The screening cohort is municipalities in Hokkaido, Gunma, Hiroshima and Nagasaki prefectures, which have about 100 000 men in the age range between 50 and 79. Within the screening cohort, a campaign on screening for prostate cancer has been conducted and it is expected to have a high exposure rate of screening of over 60% over 5 years. Control cohorts are municipalities in the same prefectures and also have almost the same male populations. Aggressive promotion of screening for prostate cancer has not been carried out in the control cohorts. In Gunma Prefecture, compliance with PSA screening in the screening cohort (Isesaki city) is high at about 75% over 5 years. The number of cases with prostate cancer has increased rapidly since conducting JPSPS in the screening cohort (Isesaki city). However, contamination of screening for prostate cancer in the control cohort (Kiryu city) was still low at 8% between 1992 and 2006. In the near future, changes in the number of metastatic prostate cancer cases in the screening and control cohort will be announced. Changes in the mortality rate of prostate cancer will be assessed at around 2012.

References

  1. Top of page
  2. Abstract
  3. Policy statement of the Japanese Urological Association on screening for prostate cancer
  4. Theoretical background of the policy statement
  5. Review of the literature on the pros and cons of PSA screening
  6. Informed consent in screening for prostate cancer
  7. Ideal screening system in Japan
  8. Merits and demerits of screening for prostate cancer
  9. Baseline consensus on screening for prostate cancer
  10. Ongoing study on screening for prostate cancer in Japan
  11. References