GUIDELINE SYNTHESIS
SCREENING FOR PROSTATE CANCER
Guidelines
1. American College of Preventive Medicine (ACPM). Screening for
prostate cancer in American men
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=555> . Am J
Prev Med 1998 Jul;15(1):81-4 [43 references].
2. American Urological Association, Inc. (AUA). Prostate specific
antigen: Best practice policy
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=1407> .
Baltimore (MD): American Urological Association, Inc., 1999. 30 p [130
references].
3. Singapore Ministry of Health (MOH). Prostate cancer
<http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=2062> .
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 <http://www.guideline.gov/FRAMESETS/guideline_fs.asp?guideline=1973> .
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.