GUIDELINE SYNTHESIS

SCREENING FOR PROSTATE CANCER

Guidelines

1.       American College of Preventive Medicine (ACPM). Screening for prostate cancer in American men. Am J Prev Med 1998 Jul;15(1):81-4 [43 references].

2.       American Urological Association, Inc. (AUA). Prostate specific antigen: Best practice policy. Baltimore (MD): American Urological Association, Inc., 1999. 30 p [130 references].

3.       Singapore Ministry of Health (MOH). Prostate cancer. Singapore: Ministry of Health (Singapore); 2000 May. 49 p. (Ministry of Health Singapore clinical practice guidelines; no. 3/00). [168 references]

4.       American Cancer Society (ACS). Recommendations from the American Cancer Society Workshop on Early Prostate Cancer Detection, May 4-6, 2000 and ACS guideline on testing for early prostate cancer detection: update 2001. CA Cancer J Clin 2001 Jan-Feb;51(1):39-44 [181 references].

Areas of Agreement

All four organizations recommend against routinely screening men for prostate cancer, primarily due to the lack of proof that screening can reduce mortality from prostate cancer. In addition, ACPM, AUA, and ACS address the clear potential that screening will increase treatment-related morbidity. For the American male population, ACPM is more explicit about not recommending population-based screening than AUA and ACS. The Singapore MOH is explicit in their recommendations against routine prostate cancer screening in Asian males.

For men 50 years of age and older with at least a 10 year life expectancy and for men less than 50 years of age at risk for developing prostate cancer, ACPM, AUA, and ACS assert that men should make an informed decision regarding prostate cancer screening with the help of their physicians. Singapore MOH suggests that all males be considered for prostate screening who are above 40 years of age at risk for developing prostate cancer.

The use of transrectal ultrasound as a screening test for prostate cancer is no longer considered by ACPM and the AUA recommends against it. ACS does not discuss this test in their guideline, and although the Singapore MOH does not address transrectal ultrasound as a screening test, they consider it in combination with biopsy for diagnostic purposes.

Areas of Differences

There are no areas of significant difference among the ACPM, AUA, Singapore MOH, and ACS guidelines.

Abbreviations:

·         ACPM, American College of Preventive Medicine

·         ACS, American Cancer Society

·         AUA, American Urological Association

·         DRE, digital rectal examination

·         PSA, prostate specific antigen

·         MOH, Ministry of Health

 

BENEFITS AND HARMS

 

POTENTIAL BENEFITS ASSOCIATED WITH PROSTATE CANCER SCREENING

 

 

ACPM (1998 Jul)

Screening potentially could result in decreased morbidity and mortality due to early detection and treatment of prostate cancer. However, there is no direct evidence whether or not early detection and treatment of prostate cancer reduces mortality because randomized clinical trials to address the question have not been completed. Because screening may be detecting cancers that would never have caused morbidity or mortality in the host, the value of early detection remains unclear.

 

 

AUA
(1999)

PSA testing detects more tumors than does DRE and detects them earlier. Although many of these tumors have aggressive characteristics, some may grow slowly enough that they pose no risk to the patient. As yet, there is no way to identify with certainty the tumor that has no risk of spreading and potentially causing premature death or morbidity.

 

 

Singapore MOH
(2000)

While the incidence of prostate cancer is substantially lower than that in many Western countries, it has been increasing even after having corrected for life expectancy. The majority of patients with prostate cancer present with locally advanced and/or metastatic disease at the time of first diagnosis. The prognosis of advanced prostate cancer is poor despite the most aggressive treatment. Cure is impossible for metastatic prostate cancer. The median time to progression and median survival is approximately 18 and 30 months respectively. Such data contrast sharply with the results of treatment for localized disease where medial survival has been shown to be longer than 15 years. The observed crude survival rates are identical to the expected survival of age-matched controls. As such, it is reasonable to strive for early diagnosis and treatment in the hope of survival benefits. However, uncertainties of the natural history of the disease and efficacy of treatment due to the lack of randomised control studies still cast doubts on the potential benefits of a screening programme.

The combination of DRE and PSA enhances early detection.

Clinically significant cancers are detected by PSA testing. PSA-based screening has induced a stage migration, but only very preliminary indications of improved survival are available.

 

 

ACS
(2001)

Prostate cancer screening may result in the diagnosis of earlier-stage disease in younger men, which may decrease prostate cancer mortality rates.

However, no direct evidence exists to show that prostate-specific antigen (PSA) screening decreases prostate cancer mortality rates.

 

 

POTENTIAL HARMS ASSOCIATED WITH PROSTATE CANCER SCREENING

 

 

ACPM (1998 Jul)

Both screening and treatment can be harmful. A positive DRE and/or PSA requiring repeat testing can lead to more invasive diagnostic tests, such as needle biopsy, which carries a small risk of infection, sepsis or bleeding. Radical prostatectomy and radiation therapy can produce serious complications affecting quality of life such a urinary incontinence, erectile dysfunction, or stricture. Little is known about the individual psychological burden involved in prostate cancer screening and decision-making regarding treatment.

 

 

AUA
(1999)

Tradeoff associated with improving PSA sensitivity: Both age-adjusted PSA and PSA velocity will increase the number of cancers detected, but both will also increase the number of men undergoing biopsy.

Tradeoff associated with improving PSA specificity: All three methods to improve PSA specificity (age-adjusted PSA, free-to-total PSA ratio, PSA density) will reduce the number of biopsies in men who do not have prostate cancer but will increase the risk that some prostate cancers will be missed.

Complications of confirmatory testing: Prostate biopsy by means of a transrectal, ultrasound guide, are rarely complicated by rectal bleeding, hematuria, or prostatic infection. After biopsy, blood in the stool or urine usually disappears in a few days. Blood in the semen can be seen for up to several weeks after biopsy.

 

 

Singapore MOH
(2000)

Not stated

 

 

ACS
(2001)

Since prostate-specific antigen is prostate-tissue specific and not prostate-cancer specific, there is no absolute value that is applicable to all men. The range of "normal" prostate-specific antigen levels has conventionally been considered to be between zero and 4.0 ng/dl. A lower cut-off value of 2.5 ng/dl has been shown to improve the early detection of organ-confined prostate cancers; however, this also increases the number of men undergoing biopsy in whom no cancer is detected.

 

 

 

 

 

 

 

 

 

COMPARISON OF RECOMMENDATIONS FOR PROSTATE CANCER SCREENING

 

ACPM (1998 Jul)

The American College of Preventive Medicine (ACPM) recommends against routine population screening with digital rectal examination and prostate specific antigen. Men age 50 or older with a life expectancy of greater than 10 years should be given information about the potential benefits and harms of screening and limits of current evidence and should be allowed to make their own choice about screening, in consultation with their physician, based on personal preferences. Methods and tools for helping patients review this information are available; however, the ACPM recommends further research be conducted in optimizing the process of patient education and informed consent.

 

AUA
(1999)

Early detection of prostate cancer should be offered to asymptomatic men 50 years of age or older with an estimated life expectancy of more than 10 years. It is reasonable to offer testing at an earlier age to men with defined risk factors, including men with a first-degree relative who has prostate cancer and African American men.

Decisions regarding early detection of prostate cancer should be individualized and benefits and consequences should be discussed with the patient before PSA testing occurs.

Ideally, physicians should consider a number of factors including patient age and comorbidity as well as preferences for the relevant potential outcomes. Some organizations have even recommended that informed consent should be obtained prior to PSA testing.

PSA testing detects more tumors than does DRE, and it detects them earlier. However, the most sensitive method for early detection of prostate cancer uses both DRE and PSA. Both tests should be employed in a program of early prostate cancer detection.

Evidence from three uncontrolled studies that allow a direct comparison of the yields of PSA and DRE suggests that combining both tests improves the overall rate of prostate cancer detection when compared with either test alone. The value of serial determinations of PSA or serial DRE in patients with a normal initial examination is unknown. There is evidence that serial PSA determinations lead to a decrease in detection of pathologically advanced disease.

Transrectal ultrasonography is not a useful test for early prostate cancer detection; it adds little to the combination of PSA and DRE.

 

Singapore MOH
(2000)

At present, population based screening is not recommended among Asians. (Grade A, Level Ia)

All males above 40 years of age with the risk factor of having a first degree relative with prostate cancer at young age (younger than 60 years) may be screened. (Good Practice Point)

Prostate specific antigen

The appropriate threshold prostate specific antigen level for the detection of cancer of the prostate is 4.0 ng/mL. (Grade B, Level IIb)

Clinically significant cancers are detected by testing. (Grade B, Level IIa)

Prostate specific antigen-based screening has induced a stage migration but only very preliminary indications of improved survival are available. (Grade C, Level IV)

The ratio of free to total prostate specific antigen levels is recommended as the sensitivity and specificity of levels at 2 to 10 ng/ ml for detecting cancer of the prostate is higher. (Grade B, Level IIa) However, the optimal cut-off level is still being investigated.

Digital rectal examination

Digital rectal examination is recommended as the combination of digital rectal examination and prostate specific antigen test enhances early prostate cancer detection. (Grade B, Level IIa)

 

ACS
(2001)

The American Cancer Society (ACS) recommends that both the PSA test and the DRE should be offered annually beginning at age 50, to men who have a life expectancy of at least 10 years. Men at high risk should begin testing at age 45. Information should be provided to patients about benefits and limitations of testing. Specifically, prior to testing, men should have an opportunity to learn about the benefits and limitations of testing for early prostate cancer detection and treatment.

High-risk groups include men of African descent (specifically, sub-Saharan African descent) and men with a first-degree relative diagnosed at a young age. Risk increases with the number of first-degree relatives affected by prostate cancer.

 

 

COMPARISON OF SCOPE AND CONTENT

ACPM
(1998 Jul)

Objective:
To present a practice policy statement on screening for prostate cancer in American men.

Interventions and Practices Considered:

  • DRE
  • Serum tumor markers (e.g., PSA)
  • Transrectal ultrasound

Target Population:
American men 40 years of age and older

AUA
(1999)

Objective:
To provide current information on the use of PSA testing for 1) early detection of prostate cancer, 2) assistance in pretreatment staging, and 3) the post-treatment monitoring and management of men with this disease.

Interventions and Practices Considered:

  • PSA
  • DRE
  • Transrectal ultrasound

Target Population:

  • Asymptomatic men age 50 or over with an anticipated life expectancy of 10 or more years
  • Asymptomatic men age 40 to 50 years old with a family history of prostate cancer or African-American ethnicity with an anticipated life expectancy of 10 or more years

Singapore MOH
(2000)

Objective:
To provide recommendations for the management of patients with prostate cancer.

Interventions and Practices Considered:

  • DRE
  • Measurement of PSA levels

    Interventions for the diagnosis, management and treatment of prostate cancer are also presented in the guideline. Transrectal ultrasound with and without biopsy is discussed in the context of diagnosis rather than screening.

Target Population:
Asian men, 40 years of age and older with the risk factor of having a first degree relative with prostate cancer at a young age (< 60 years)

ACS
(2001)

Objectives:
To update the 1997 American Cancer Society guideline pertaining to prostate cancer screening.

To offer recommendations to health care professionals and the public for informed decision-making related to early detection of prostate cancer

Interventions and Practices Considered:

  • DRE
  • PSA blood test

Target Population:

  • Men aged 50 years and older who have a life expectancy of at least 10 years and younger men who are at high risk for prostate cancer
  • Men aged 45 years and older of Sub-Saharan African descent or with first-degree relative diagnosed at a young age
  • Men 40 and older with multiple first-degree relatives diagnosed with prostate cancer at an early age

 

GUIDELINE CONTENT COMPARISON

The American College of Preventive Medicine (ACPM), the American Urological Association (AUA), the Singapore Ministry of Health (MOH), and the American Cancer Society (ACS) present recommendations for screening men for prostate cancer and provide explicit reasoning behind their judgments.

The guideline from the Singapore MOH provides recommendations for diagnosis, treatment, and management of prostate cancer in addition to the recommendations for screening for the disease. The focus of the AUA guideline is PSA and recommendations are provided for the use of this test in screening, pretreatment staging and post-treatment management of men with prostate cancer.

The Singapore MOH guideline targets Asian men whereas the ACPM, AUA, and ACS guidelines target American men.


This Synthesis was prepared by NGC on December 28, 1998 and revised to include additional guideline developers on April 18, 2000. It was reviewed by the guideline developers as of June 27, 2000. Updated recommendations issued by the American Cancer Society (ACS) were incorporated into this synthesis by NGC on April 20, 2001 and were reviewed by the guideline developer as of August 28, 2001. This Synthesis was most recently updated on March 15, 2002 to incorporate Singapore MOH guidelines. Recommendations from USPSTF and CTFPHC were also removed from this Synthesis following their withdrawal from the NGC Web site.

 

Edward E. Rylander, M.D.

Diplomat American Board of Family Practice.

Diplomat American Board of Palliative Medicine.