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## Complete Summary

#### GUIDELINE TITLE

Screening for prostate cancer: U.S. Preventive Services Task Force
recommendation statement.

#### BIBLIOGRAPHIC SOURCE(S)

U.S. Preventive Services Task Force. Screening for prostate cancer: U.S.
Preventive Services Task Force recommendation statement. Ann Intern
Med 2008 Aug 5;149(3):185-91. \[19 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18678845)

#### GUIDELINE STATUS

This is the current release of the guideline.

It updates a previously published version: Screening for prostate
cancer: recommendations and rationale. Ann Intern Med 2002 Dec
3;137(11):915-6. \[8 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12458992).

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Prostate cancer

#### GUIDELINE CATEGORY

Prevention\
Screening

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Preventive Medicine\
Urology

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Health Care Providers\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

-   To summarize the current U.S. Preventive Services Task Force
    (USPSTF) recommendations and supporting scientific evidence on
    screening for prostate cancer

-   To update the 2002 USPSTF recommendations on screening for prostate
    cancer

#### TARGET POPULATION

Adult males

#### INTERVENTIONS AND PRACTICES CONSIDERED

Screening for prostate cancer using prostate-specific antigen (PSA)

#### MAJOR OUTCOMES CONSIDERED

**Key Question 1**: Does screening for prostate cancer with
prostate-specific antigen (PSA), as a single-threshold test or as a
function of multiple tests over time, decrease morbidity or mortality?

**Key Question 2**: What are the magnitude and nature of harms
associated with prostate cancer screening other than overtreatment?

**Key Question 3**: What is the natural history of PSA-detected,
non-palpable, localized prostate cancer?

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: A targeted
evidence review was prepared by the Agency for Healthcare Research and
Quality (AHRQ) staff for use by the U.S. Preventive Services Task Force
(USPSTF) (see the \"Availability of Companion Documents\" field).

In 2002, the USPSTF found insufficient evidence to recommend for or
against routine screening for prostate cancer. The USPSTF found good
evidence that prostate-specific antigen (PSA) screening can detect
early-stage prostate cancer but found mixed and inconclusive evidence
that screening and early detection improve health outcomes.
Consequently, the USPSTF was unable to determine the balance between
benefits and harms of periodic screening for prostate cancer.

The analytic framework that guided the previous USPSTF evidence review
(see Figure in the Evidence Update \[see the \"Availability of Companion
Documents\" field\]) included 8 key questions about benefits and harms
of prostate cancer screening and treatment. This evidence update focuses
on critical gaps in the evidence that the Task Force identified in the
previous review: the lack of good-quality studies linking screening to
improved health outcomes; limited information about harms of screening;
and a paucity of knowledge about the natural history of PSA-detected,
nonpalpable, localized prostate cancer (the most common type of prostate
cancer detected today). These evidence gaps produced 3 new key questions
for this update:

1.  Does screening for prostate cancer with PSA, as a single-threshold
    test or as a function of multiple tests over time, decrease
    morbidity or mortality?

2.  What are the magnitude and nature of harms associated with prostate
    cancer screening other than overtreatment?

3.  What is the natural history of PSA-detected, nonpalpable, localized
    prostate cancer?

After consultation with USPSTF liaisons and content experts, AHRQ staff
chose a broad definition of PSA screening that included evolving
prognostic measures, such as PSA velocity and doubling time. However, a
comparison of the performance characteristics of such measures with
traditional single-threshold PSA testing is outside the scope of this
review.

**Data Sources**

For evidence on health outcomes associated with PSA screening, PubMed
was searched for English-language articles indexed between 1 January
2002 and 12 July 2007 by using combinations of the Medical Subject
Heading (MeSH) terms and keywords *prostate neoplasms, screening,
prostate-specific antigen, early diagnosis, PSA velocity, PSA doubling
time*, and *prostate specific antigen doubling*.

For evidence on the harms of screening for prostate cancer, PubMed was
searched for English-language articles indexed between 1 January 2002,
and 12 July 2007 by using combinations of the MeSH terms and keywords
*prostate neoplasms; screening; false positive reactions; adverse
effects; mass screening/adverse effects; mass screening/psychology;
anxiety; quality of life*; and *health knowledge, attitudes, practice*.

For evidence on the natural history of PSA-detected, nonpalpable,
localized prostate cancer, PubMed was searched for English-language
articles indexed between 1 January 2002 and 23 August 2007 by using
combinations of the MeSH terms and keywords *prostatic neoplasms,
natural history, epidemiology, disease progression, survival analysis,
watchful waiting, active surveillance, population surveillance,
expectant management,* and *conservative management*.

Additional articles were identified through a search of the Cochrane
Library, recommendations of experts, and a hand search of reference
lists from major review articles and studies.

**Study Selection**

Two reviewers independently reviewed the title lists, abstracts, and
full articles by using predetermined inclusion and exclusion criteria.
Articles selected by at least 1 reviewer advanced to the next stage of
review.

For key question 1, eligible studies were randomized, controlled trials
(RCTs), meta-analyses, and systematic reviews that compared screening
with no screening (or usual care) in general primary care populations
and reported morbidity or mortality outcomes. Although the 2002 USPSTF
review considered case--control studies and ecological data related to
this key question, these study types were excluded from this part of the
evidence update to avoid potential sources of confounding that are
inherent in nonrandomized studies.

For key question 2, eligible studies were randomized or nonrandomized
comparative studies that reported quantitative health or quality-of-life
outcomes related to a false-positive screening result. Studies that
reported only harms resulting from prostate cancer treatment were
excluded.

For key question 3, eligible studies were RCTs and cohort studies that
reported health outcomes of patients with stage T1c (nonpalpable,
localized, PSA-detected) prostate cancer who did not receive active
treatment (including patients assigned to watchful waiting or active
surveillance protocols). To ensure that the most applicable information
on natural history was retrieved, studies that predominantly involved
patients with non--PSA-detected cancer (defined as comprising
[\>]{.underline}80% of the study population), were too small to draw
reliable conclusions about health outcomes (defined as \<50 patients in
the watchful waiting or surveillance group), or did not provide separate
data on patients with stage T1c prostate cancer were excluded.

#### NUMBER OF SOURCE DOCUMENTS

10 articles met inclusion criteria for this evidence update.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: A targeted
evidence review was prepared by the Agency for Healthcare Research and
Quality (AHRQ) staff for use by the U.S. Preventive Services Task Force
(USPSTF) (see the \"Availability of Companion Documents\" field).

**Data Extraction and Quality Assessment**

For all citations that met the initial eligibility criteria, 2 reviewers
reviewed the full articles and independently rated their quality by
using previously published USPSTF criteria. Disagreements between
reviewers regarding article inclusion and quality rating were resolved
through a consensus process. The quality of randomized controlled trials
(RCTs) and cohort studies were assessed on the following items: initial
assembly and maintenance of comparable groups; absence of important
differential loss to follow-up or overall high loss to followup; use of
equal, valid, and reliable outcome measurements; clear definition of
interventions; and appropriateness of outcomes. Systematic reviews and
meta-analyses were evaluated on the following items: comprehensiveness
of sources considered, appropriateness of search strategy, standard
appraisal of included studies, validity of conclusions, recency, and
relevance. The Appendix Table (available at
<http://www.ahrq.gov/clinic/uspstf/uspsprca.htm>) describes more
thoroughly the criteria and definitions for USPSTF quality ratings.

**Data Synthesis and Analysis**

The data were synthesized qualitatively by key question in tabular and
narrative formats. Data from the 2002 USPSTF review relevant to key
questions 1 and 2 are included to facilitate an overall assessment of
the body of evidence. Qualitative synthesis was not performed because of
the paucity and heterogeneity of included studies.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Balance Sheets\
Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The U.S. Preventive Services Task Force (USPSTF) systematically reviews
the evidence concerning both the benefits and harms of widespread
implementation of a preventive service. It then assesses the certainty
of the evidence and the magnitude of the benefits and harms. On the
basis of this assessment, the USPSTF assigns a letter grade to each
preventive service signifying its recommendation about provision of the
service (see Table below). An important, but often challenging, step is
determining the balance between benefits and harms to estimate \"net
benefit\" (that is, benefits minus harms).

**Table 1. U.S. Preventive Services Task Force Recommendation Grid\***

  ------------------------------------------------------------------------------------------
  **Certainty of Net        **Magnitude of                               
  Benefit**                 Net Benefit**                                
  ------------------------- ----------------- -------------- ----------- -------------------
                            **Substantial**   **Moderate**   **Small**   **Zero/Negative**

  High                      A                 B              C           D

  Moderate                  B                 B              C           D

  Low                       Insufficient                                 
  ------------------------------------------------------------------------------------------

\**A*, *B*, *C*, *D*, and *I (Insufficient)* represent the letter grades
of recommendation or statement of insufficient evidence assigned by the
U.S. Preventive Services Task Force after assessing certainty and
magnitude of net benefit of the service (see the \"Rating Scheme for the
Strength of the Recommendations\" field).

The overarching question that the Task Force seeks to answer for every
preventive service is whether evidence suggests that provision of the
service would improve health outcomes if implemented in a general
primary care population. For screening topics, this standard could be
met by a large randomized, controlled trial (RCT) in a representative
asymptomatic population with follow-up of all members of both the group
\"invited for screening\" and the group \"not invited for screening.\"

Direct RCT evidence about screening is often unavailable, so the Task
Force considers indirect evidence. To guide its selection of indirect
evidence, the Task Force constructs a \"chain of evidence\" within an
analytic framework. For each key question, the body of pertinent
literature is critically appraised, focusing on the following 6
questions:

1.  Do the studies have the appropriate research design to answer the
    key question(s)?

2.  To what extent are the existing studies of high quality? (i.e., what
    is the internal validity?)

3.  To what extent are the results of the studies generalizable to the
    general U.S. primary care population and situation? (i.e., what is
    the external validity?)

4.  How many studies have been conducted that address the key
    question(s)? How large are the studies? (i.e., what is the precision
    of the evidence?)

5.  How consistent are the results of the studies?

6.  Are there additional factors that assist us in drawing conclusions
    (e.g., presence or absence of dose-response effects, fit within a
    biologic model)?

The next step in the Task Force process is to use the evidence from the
key questions to assess whether there would be net benefit if the
service were implemented. In 2001, the USPSTF published an article that
documented its systematic processes of evidence evaluation and
recommendation development. At that time, the Task Force\'s overall
assessment of evidence was described as good, fair, or poor. The Task
Force realized that this rating seemed to apply only to how well studies
were conducted and did not fully capture all of the issues that go into
an overall assessment of the evidence about net benefit. To avoid
confusion, the USPSTF has changed its terminology. Whereas individual
study quality will continue to be characterized as good, fair, or poor,
the term *certainty* will now be used to describe the Task Force\'s
assessment of the overall body of evidence about net benefit of a
preventive service and the likelihood that the assessment is correct.
Certainty will be determined by considering all 6 questions listed
above; the judgment about certainty will be described as high, moderate,
or low.

In making its assessment of certainty about net benefit, the evaluation
of the evidence from each key question plays a primary role. It is
important to note that the Task Force makes recommendations for
real-world medical practice in the United States and must determine to
what extent the evidence for each key question---even evidence from
screening RCTs or treatment RCTs---can be applied to the general primary
care population. Frequently, studies are conducted in highly selected
populations under special conditions. The Task Force must consider
differences between the general primary care population and the
populations studied in RCTs and make judgments about the likelihood of
observing the same effect in actual practice.

It is also important to note that 1 of the key questions in the analytic
framework refers to the potential harms of the preventive service. The
Task Force considers the evidence about the benefits and harms of
preventive services separately and equally. Data about harms are often
obtained from observational studies because harms observed in RCTs may
not be representative of those found in usual practice and because some
harms are not completely measured and reported in RCTs.

Putting the body of evidence for all key questions together as a chain,
the Task Force assesses the certainty of net benefit of a preventive
service by asking the 6 major questions listed above. The Task Force
would rate a body of convincing evidence about the benefits of a service
that, for example, derives from several RCTs of screening in which the
estimate of benefits can be generalized to the general primary care
population as \"high\" certainty (see the \"Rating Scheme for the
Strength of Recommendations\" field). The Task Force would rate a body
of evidence that was not clearly applicable to general practice or has
other defects in quality, research design, or consistency of studies as
\"moderate\" certainty. Certainty is \"low\" when, for example, there
are gaps in the evidence linking parts of the analytic framework, when
evidence to determine the harms of treatment is unavailable, or when
evidence about the benefits of treatment is insufficient. Table 4 in the
methodology document listed below (see \"Availability of Companion
Documents\" field) summarizes the current terminology used by the Task
Force to describe the critical assessment of evidence at all 3 levels:
individual studies, key questions, and overall certainty of net benefit
of the preventive service.

Sawaya GF et al., Update on the methods of the U.S. Preventive Services
Task Force: estimating certainty and magnitude of net benefit. Ann
Intern Med. 2007;147:871-875 \[5 references\].

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**What the United States Preventive Services Task Force (USPSTF) Grades
Mean and Suggestions for Practice**

  ---------------------------------------------------------------------------
  **Grade**   **Grade Definitions**          **Suggestions for Practice**
  ----------- ------------------------------ --------------------------------
  A           The USPSTF recommends the      Offer or provide this service.
              service. There is high         
              certainty that the net benefit 
              is substantial.                

  B           The USPSTF recommends the      Offer or provide this service.
              service. There is high         
              certainty that the net benefit 
              is moderate or there is        
              moderate certainty that the    
              net benefit is moderate to     
              substantial.                   

  C           The USPSTF recommends against  Offer/provide this service only
              routinely providing the        if there are other
              service. There may be          considerations in support of the
              considerations that support    offering/providing the service
              providing the service in an    in an individual patient.
              individual patient. There is   
              moderate or high certainty     
              that the net benefit is small. 

  D           The USPSTF recommends against  Discourage the use of this
              the service. There is moderate service.
              or high certainty that the     
              service has no net benefit or  
              that the harms outweigh the    
              benefits.                      

  I\          The USPSTF concludes that the  Read \"Clinical Considerations\"
  Statement   current evidence is            section of USPSTF Recommendation
              insufficient to assess the     Statement (see \"Major
              balance of benefits and harms  Recommendations\" field). If
              of the service. Evidence is    offered, patients should
              lacking, of poor quality or    understand the uncertainty about
              conflicting, and the balance   the balance of benefits and
              of benefits and harms cannot   harms.
              be determined.                 
  ---------------------------------------------------------------------------

**USPSTF Levels of Certainty Regarding Net Benefit**

**Definition**: The U.S. Preventive Services Task Force defines
certainty as \"likelihood that the USPSTF assessment of the net benefit
of a preventive service is correct.\" The net benefit is defined as
benefit minus harm of the preventive service as implemented in a
general, primary care population. The USPSTF assigns a certainty level
based on the nature of the overall evidence available to assess the net
benefit of a preventive service.

+---------+------------------------------------------------------------+
| **Level | **Description**                                            |
| of      |                                                            |
| Cert    |                                                            |
| ainty** |                                                            |
+=========+============================================================+
| High    | The available evidence usually includes consistent results |
|         | from well-designed, well-conducted studies in              |
|         | representative primary care populations. These studies     |
|         | assess the effects of the preventive service on health     |
|         | outcomes. This conclusion is therefore unlikely to be      |
|         | strongly affected by the results of future studies.        |
+---------+------------------------------------------------------------+
| M       | The available evidence is sufficient to determine the      |
| oderate | effects of the preventive service on health outcomes, but  |
|         | confidence in the estimate is constrained by factors such  |
|         | as:                                                        |
|         |                                                            |
|         | -   The number, size, or quality of individual studies     |
|         |                                                            |
|         | -   Inconsistency of findings across individual studies    |
|         |                                                            |
|         | -   Limited generalizability of findings to routine        |
|         |     primary care practice                                  |
|         |                                                            |
|         | -   Lack of coherence in the chain of evidence             |
|         |                                                            |
|         | As more information becomes available, the magnitude or    |
|         | direction of the observed effect could change, and this    |
|         | change may be large enough to alter the conclusion.        |
+---------+------------------------------------------------------------+
| Low     | The available evidence is insufficient to assess effects   |
|         | on health outcomes. Evidence is insufficient because of:   |
|         |                                                            |
|         | -   The limited number or size of studies                  |
|         |                                                            |
|         | -   Important flaws in study design or methods             |
|         |                                                            |
|         | -   Inconsistency of findings across individual studies    |
|         |                                                            |
|         | -   Gaps in the chain of evidence                          |
|         |                                                            |
|         | -   Findings not generalizable to routine primary care     |
|         |     practice                                               |
|         |                                                            |
|         | -   A lack of information on important health outcomes     |
|         |                                                            |
|         | More information may allow an estimation of effects on     |
|         | health outcomes.                                           |
+---------+------------------------------------------------------------+

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Comparison with Guidelines from Other Groups\
External Peer Review\
Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

[Peer Review]{.underline}. Before the U.S. Preventive Services Task
Force makes its final determinations about recommendations on a given
preventive service, the Evidence-based Practice Center and the Agency
for Healthcare Research and Quality send a draft systematic evidence
review to 4 to 6 external experts and to federal agencies and
professional and disease-based health organizations with interests in
the topic. They ask the experts to examine the review critically for
accuracy and completeness and to respond to a series of specific
questions about the document. After assembling these external review
comments and documenting the proposed response to key comments, the
topic team presents this information to the Task Force in memo form. In
this way, the Task Force can consider these external comments and a
final version of the systematic review before it votes on its
recommendations about the service. Draft recommendations are then
circulated for comment from reviewers representing professional
societies, voluntary organizations and Federal agencies. These comments
are discussed before the whole U.S. Preventive Services Task Force
before final recommendations are confirmed.

[Recommendations of Others]{.underline}. Recommendations for screening
for prostate cancer from the following groups were discussed: the
American Academy of Family Physicians, the American College of
Physicians, the American College of Preventive Medicine, the American
Medical Association, the American Cancer Society, and the American
Urological Association.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The US Preventive Services Task Force (USPSTF) grades its
recommendations (A, B, C, D, or I) and identifies the Levels of
Certainty regarding Net Benefit (High, Moderate, and Low). The
definitions of these grades can be found at the end of the \"Major
Recommendations\" field.

**[Summary of Recommendations and Evidence]{.underline}**

-   The USPSTF concludes that the current evidence is insufficient to
    assess the balance of benefits and harms of prostate cancer
    screening in men younger than age 75 years. **This is an I
    statement.**

-   The USPSTF recommends against screening for prostate cancer in men
    age 75 years or older. **This is a grade D recommendation.**

**[Clinical Considerations]{.underline}**

**Patient Population under Consideration**

This recommendation applies to men in the general U.S. population.

**Risk Assessment**

Older men, African-American men, and men with a family history of
prostate cancer are at increased risk for diagnosis and death from
prostate cancer. Unfortunately, the previously described gaps in the
evidence regarding potential benefits of screening also apply to these
men.

**Screening Tests**

The prostate-specific antigen (PSA) test is more sensitive than the
digital rectal examination for detecting prostate cancer. The
conventional PSA screening cut-point of 4.0 micrograms/L detects many
prostate cancer cases; however, some early cases of prostate cancer will
be missed by this cut-point. Using a lower cut-point to define an
abnormal PSA detects more cases of cancer.

The proportion of cancer cases detected by lower cutpoints that would
ever become clinically apparent is unknown; lower cut-points would label
many more men as potentially having cancer. For example, lowering the
PSA cut-point to 2.5 micrograms/L would more than double the number of
U.S. men between 40 and 69 years of age with abnormal results.

Variations of PSA screening, including the use of age-adjusted PSA
cut-points, free PSA, PSA density, PSA velocity, PSA slope, and PSA
doubling time, have been proposed to improve detection of \"clinically
important\" prostate cancer cases. However, no evidence suggests that
any of these testing strategies improves health outcomes.

**Suggestions for Practice**

Given the uncertainties and controversy surrounding prostate cancer
screening in men younger than age 75 years, a clinician should not order
the PSA test without first discussing with the patient the potential but
uncertain benefits and the known harms of prostate cancer screening and
treatment. Men should be informed of the gaps in the evidence and should
be assisted in considering their personal preferences before deciding
whether to be tested.

**Treatment**

Because of the uncertainty about the benefits of treating prostate
cancer detected by screening men younger than age 75 years, there is no
consensus regarding optimal treatment. Current management strategies for
localized prostate cancer include watchful waiting (observation with
palliative treatment for symptoms only), active surveillance (periodic
biochemical monitoring with conversion to curative treatment for signs
of disease progression), radical prostatectomy, external-beam radiation
therapy, and brachytherapy (or radioactive seed implantation therapy).

If treatment for prostate cancer detected by screening improves health
outcomes, the population most likely to benefit from screening will be
men age 50 to 74 years. Even if prostate cancer screening is determined
to be effective, the length of time required to experience a mortality
benefit is greater than 10 years. Because a 75-year-old man has an
average life expectancy of about 10 years, very few men age 75 years or
older would experience a mortality benefit. Similarly, men younger than
age 75 years who have chronic medical problems and a life expectancy of
fewer than 10 years are also unlikely to benefit from screening and
treatment.

**Screening Intervals**

The yield of screening in terms of cancer cases detected declines
rapidly with repeated annual testing. If screening were to reduce
deaths, PSA screening as infrequent as every 4 years could yield as much
of a benefit as annual screening.

**[Definitions]{.underline}**:

**What the United States Preventive Services Task Force (USPSTF) Grades
Mean and Suggestions for Practice**

  ---------------------------------------------------------------------------
  **Grade**   **Grade Definitions**          **Suggestions for Practice**
  ----------- ------------------------------ --------------------------------
  A           The USPSTF recommends the      Offer or provide this service.
              service. There is high         
              certainty that the net benefit 
              is substantial.                

  B           The USPSTF recommends the      Offer or provide this service.
              service. There is high         
              certainty that the net benefit 
              is moderate or there is        
              moderate certainty that the    
              net benefit is moderate to     
              substantial.                   

  C           The USPSTF recommends against  Offer/provide this service only
              routinely providing the        if there are other
              service. There may be          considerations in support of the
              considerations that support    offering/providing the service
              providing the service in an    in an individual patient.
              individual patient. There is   
              moderate or high certainty     
              that the net benefit is small. 

  D           The USPSTF recommends against  Discourage the use of this
              the service. There is moderate service.
              or high certainty that the     
              service has no net benefit or  
              that the harms outweigh the    
              benefits.                      

  I\          The USPSTF concludes that the  Read \"Clinical Considerations\"
  Statement   current evidence is            section of USPSTF Recommendation
              insufficient to assess the     Statement (see \"Major
              balance of benefits and harms  Recommendations\" field). If
              of the service. Evidence is    offered, patients should
              lacking, of poor quality or    understand the uncertainty about
              conflicting, and the balance   the balance of benefits and
              of benefits and harms cannot   harms.
              be determined.                 
  ---------------------------------------------------------------------------

**USPSTF Levels of Certainty Regarding Net Benefit**

**Definition**: The U.S. Preventive Services Task Force defines
certainty as \"likelihood that the USPSTF assessment of the net benefit
of a preventive service is correct.\" The net benefit is defined as
benefit minus harm of the preventive service as implemented in a
general, primary care population. The USPSTF assigns a certainty level
based on the nature of the overall evidence available to assess the net
benefit of a preventive service.

+---------+------------------------------------------------------------+
| **Level | **Description**                                            |
| of      |                                                            |
| Cert    |                                                            |
| ainty** |                                                            |
+=========+============================================================+
| High    | The available evidence usually includes consistent results |
|         | from well-designed, well-conducted studies in              |
|         | representative primary care populations. These studies     |
|         | assess the effects of the preventive service on health     |
|         | outcomes. This conclusion is therefore unlikely to be      |
|         | strongly affected by the results of future studies.        |
+---------+------------------------------------------------------------+
| M       | The available evidence is sufficient to determine the      |
| oderate | effects of the preventive service on health outcomes, but  |
|         | confidence in the estimate is constrained by factors such  |
|         | as:                                                        |
|         |                                                            |
|         | -   The number, size, or quality of individual studies     |
|         |                                                            |
|         | -   Inconsistency of findings across individual studies    |
|         |                                                            |
|         | -   Limited generalizability of findings to routine        |
|         |     primary care practice                                  |
|         |                                                            |
|         | -   Lack of coherence in the chain of evidence             |
|         |                                                            |
|         | As more information becomes available, the magnitude or    |
|         | direction of the observed effect could change, and this    |
|         | change may be large enough to alter the conclusion.        |
+---------+------------------------------------------------------------+
| Low     | The available evidence is insufficient to assess effects   |
|         | on health outcomes. Evidence is insufficient because of:   |
|         |                                                            |
|         | -   The limited number or size of studies                  |
|         |                                                            |
|         | -   Important flaws in study design or methods             |
|         |                                                            |
|         | -   Inconsistency of findings across individual studies    |
|         |                                                            |
|         | -   Gaps in the chain of evidence                          |
|         |                                                            |
|         | -   Findings not generalizable to routine primary care     |
|         |     practice                                               |
|         |                                                            |
|         | -   A lack of information on important health outcomes     |
|         |                                                            |
|         | More information may allow an estimation of effects on     |
|         | health outcomes.                                           |
+---------+------------------------------------------------------------+

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

**Benefits of Detection and Early Treatment**

-   In men younger than age 75 years, the U.S. Preventive Services Task
    Force (USPSTF) found inadequate evidence to determine whether
    treatment for prostate cancer detected by screening improves health
    outcomes, compared with treatment after clinical detection.

-   In men age 75 years or older, the USPSTF found adequate evidence
    that the incremental benefits from treatment for prostate cancer
    detected by screening are small to none.

#### POTENTIAL HARMS

**Harms of Detection and Early Treatment**

-   The USPSTF found convincing evidence that treatment for prostate
    cancer detected by screening causes moderate- to-substantial harms,
    such as erectile dysfunction, urinary incontinence, bowel
    dysfunction, and death. These harms are especially important because
    some men with prostate cancer who are treated would never have
    developed symptoms related to cancer during their lifetime.

-   There is also adequate evidence that the screening process produces
    at least small harms, including pain and discomfort associated with
    prostate biopsy and psychological effects of false-positive test
    results.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   The U.S. Preventive Services Task Force (USPSTF) makes
    recommendations about preventive care services for patients without
    recognized signs or symptoms of the target condition.

-   Recommendations are based on a systematic review of the evidence of
    the benefits and harms and an assessment of the net benefit of the
    service.

-   The USPSTF recognizes that clinical or policy decisions involve more
    considerations than this body of evidence alone. Clinicians and
    policy-makers should understand the evidence but individualize
    decision-making to the specific patient or situation.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

The experiences of the first and second U.S. Preventive Services Task
Force (USPSTF), as well as that of other evidence-based guideline
efforts, have highlighted the importance of identifying effective ways
to implement clinical recommendations. Practice guidelines are
relatively weak tools for changing clinical practice when used in
isolation. To effect change, guidelines must be coupled with strategies
to improve their acceptance and feasibility. Such strategies include
enlisting the support of local opinion leaders, using reminder systems
for clinicians and patients, adopting standing orders, and audit and
feedback of information to clinicians about their compliance with
recommended practice.

In the case of preventive services guidelines, implementation needs to
go beyond traditional dissemination and promotion efforts to recognize
the added patient and clinician barriers that affect preventive care.
These include clinicians\' ambivalence about whether preventive medicine
is part of their job, the psychological and practical challenges that
patients face in changing behaviors, lack of access to health care or of
insurance coverage for preventive services for some patients, competing
pressures within the context of shorter office visits, and the lack of
organized systems in most practices to ensure the delivery of
recommended preventive care.

Dissemination strategies have changed dramatically in this age of
electronic information. While recognizing the continuing value of
journals and other print formats for dissemination, the Agency for
Healthcare Research and Quality will make all U.S. Preventive Services
Task Force (USPSTF) products available through its [Web
site](http://www.preventiveservices.ahrq.gov/). The combination of
electronic access and extensive material in the public domain should
make it easier for a broad audience of users to access U.S. Preventive
Services Task Force materials and adapt them for their local needs.
Online access to U.S. Preventive Services Task Force products also opens
up new possibilities for the appearance of the annual, pocket-size
*Guide to Clinical Preventive Services*.

To be successful, approaches for implementing prevention have to be
tailored to the local level and deal with the specific barriers at a
given site, typically requiring the redesign of systems of care. Such a
systems approach to prevention has had notable success in established
staff-model health maintenance organizations, by addressing organization
of care, emphasizing a philosophy of prevention, and altering the
training and incentives for clinicians. Staff-model plans also benefit
from integrated information systems that can track the use of needed
services and generate automatic reminders aimed at patients and
clinicians, some of the most consistently successful interventions.
Information systems remain a major challenge for individual clinicians\'
offices, however, as well as for looser affiliations of practices in
network-model managed care and independent practice associations, where
data on patient visits, referrals, and test results are not always
centralized.

#### IMPLEMENTATION TOOLS

Patient Resources\
Personal Digital Assistant (PDA) Downloads\
Pocket Guide/Reference Cards\
Staff Training/Competency Material

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Staying Healthy

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

U.S. Preventive Services Task Force. Screening for prostate cancer: U.S.
Preventive Services Task Force recommendation statement. Ann Intern
Med 2008 Aug 5;149(3):185-91. \[19 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=18678845)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1996 (revised 2008 Aug)

#### GUIDELINE DEVELOPER(S)

United States Preventive Services Task Force - Independent Expert Panel

#### GUIDELINE DEVELOPER COMMENT

The U.S. Preventive Services Task Force (USPSTF) is a
federally-appointed panel of independent experts. Conclusions of the
U.S. Preventive Services Task Force do not necessarily reflect policy of
the U.S. Department of Health and Human Services (DHHS) or its agencies.

#### SOURCE(S) OF FUNDING

United States Government

#### GUIDELINE COMMITTEE

U.S. Preventive Services Task Force (USPSTF)

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Task Force Members\**: Ned Calonge, MD, MPH, Chair (Colorado Department
of Public Health and Environment, Denver, Colorado); Diana B. Petitti,
MD, MPH, Vice Chair (Keck School of Medicine, University of Southern
California, Sierra Madre, California); Thomas G. DeWitt, MD (Children\'s
Hospital Medical Center, Cincinnati, Ohio); Allen J. Dietrich, MD
(Dartmouth Medical School, Lebanon, NH); Kimberly D. Gregory, MD, MPH
(Cedars- Sinai Medical Center, Los Angeles, California); Russell Harris,
MD, MPH (University of North Carolina School of Medicine, Chapel Hill,
North Carolina); George J. Isham, MD, MS (HealthPartners, Minneapolis,
MN); Michael L. LeFevre, MD, MSPH (University of Missouri School of
Medicine, Columbia, Missouri); Roseanne Leipzig, MD, PhD, (Mount Sinai
School of Medicine, New York, New York): Carol Loveland-Cherry, PhD, RN
(University of Michigan School of Nursing, Ann Arbor, Michigan); Lucy N.
Marion, PhD, RN (Medical College of Georgia, Augusta, Georgia);
Bernadette Melnyk, PhD, RN (Arizona State College of Nursing and
Healthcare Innovation, Phoenix, Arizona); Virginia A. Moyer, MD, MPH
(University of Texas Health Science Center, Houston, Texas); Judith K.
Ockene, PhD (University of Massachusetts Medical School, Worcester,
Massachusetts); George F. Sawaya, MD (University of California, San
Francisco, San Francisco, California); and Barbara P. Yawn, MD, MSPH,
MSc (Olmsted Medical Center, Rochester, Minnesota)

*\*Members of the Task Force at the time this recommendation was
finalized. For a list of current Task Force members, go to
[www.ahrq.gov/clinic/uspstfab.htm](http://www.ahrq.gov/clinic/uspstfab.htm)*.

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

The U.S. Preventive Services Task Force has an explicit policy
concerning conflict of interest. All members disclose at each meeting if
they have a significant financial, professional/business, or
intellectual conflict for each topic being discussed. Task Force members
with conflicts may be recused from discussing or voting on
recommendations about the topic in question.

#### GUIDELINE STATUS

This is the current release of the guideline.

It updates a previously published version: Screening for prostate
cancer: recommendations and rationale. Ann Intern Med 2002 Dec
3;137(11):915-6. \[8 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12458992).

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [U.S. Preventive Services Task
Force (USPSTF) Web site](http://www.ahrq.gov/clinic/uspstf/uspsprca.htm)
and the [Annals of Internal Medicine Web
site](http://www.annals.org/cgi/content/full/149/3/185?maxtoshow=&HITS=25&hits=25&RESULTFORMAT=1&searchid=1&FIRSTINDEX=0&sortspec=date&resourcetype=HWCIT).

Print copies: Available from the Agency for Healthcare Research and
Quality (AHRQ) Publications Clearinghouse. For more information, go to
<http://www.ahrq.gov/news/pubsix.htm> or call 1-800-358-9295 (U.S.
only).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Lin K, Lipsitz R, Miller T, Janakiraman S. Benefits and harms of
    prostate-specific antigen screening for prostate cancer: an evidence
    update for the U.S. Preventive Services Task Force. Ann Intern Med.
    2008;149:1-8. Available from [Annals of Internal Medicine
    Online](http://www.annals.org/cgi/content/full/149/3/192?maxtoshow=&HITS=25&hits=25&RESULTFORMAT=1&searchid=1&FIRSTINDEX=0&sortspec=date&resourcetype=HWCIT).

-   Screening for prostate cancer: clinical summary of U.S. Preventive
    Services Task Force recommendation. 2008. Available in Portable
    Document Format (PDF) from the [U.S. Preventive Services Task Force
    (USPSTF) Web
    site](http://www.ahrq.gov/clinic/uspstf08/prostate/prostatesum.pdf).

-   Harris RP, Lohr KN, Beck R, Fink K, Godley P, Bunton A. Screening
    for Prostate Cancer. Rockville (MD); Agency for Healthcare Research
    and Quality; 2002 Oct. (Systematic evidence review, No. 16).
    Available in Portable Document Format (PDF) from the [Agency for
    Healthcare Research and Quality (AHRQ) Web
    site](http://www.ahrq.gov/downloads/pub/prevent/pdfser/prostser.pdf).

-   A continuing medical education (CME) activity is available from the
    [Annals of Internal Medicine Web site](http://cme.annals.org/).

Background Articles:

-   Barton M et al. How to read the new recommendation statement:
    methods update from the U.S. Preventive Services Task Force. Ann
    Intern Med. 2007;147:123-127.

-   Guirguis-Blake J et al. Current processes of the U.S. Preventive
    Services Task Force: refining evidence-based recommendation
    development. Ann Intern Med. 2007;147:117-122. \[2 references\]

-   Sawaya GF et al., Update on the methods of the U.S. Preventive
    Services Task Force: estimating certainty and magnitude of net
    benefit. Ann Intern Med. 2007;147:871-875. \[5 references\].

Electronic copies: Available from [U.S. Preventive Services Task Force
(USPSTF) Web site](http://www.ahrq.gov/clinic/uspstmeth.htm).

The following is also available:

-   The guide to clinical preventive services, 2007. Recommendations of
    the U.S. Preventive Services Task Force. Rockville (MD): Agency for
    Healthcare Research and Quality (AHRQ), 2007. 228 p. Electronic
    copies available from the [AHRQ Web
    site](http://www.ahrq.gov/clinic/pocketgd.htm).

Print copies: Available from the Agency for Healthcare Research and
Quality Publications Clearinghouse. For more information, go to
<http://www.ahrq.gov/news/pubsix.htm> or call 1-800-358-9295 (U.S.
only).

The [Electronic Preventive Services Selector
(ePSS)](http://epss.ahrq.gov/PDA/index.jsp), available as a PDA
application and a web-based tool, is a quick hands-on tool designed to
help primary care clinicians identify the screening, counseling, and
preventive medication services that are appropriate for their patients.
It is based on current recommendations of the USPSTF and can be searched
by specific patient characteristics such as age, sex, and selected
behavioral risk factors.

#### PATIENT RESOURCES

The following is available:

-   Summaries for patients. Screening for prostate cancer with
    prostate-specific antigen testing: U.S. Preventive Services Task
    Force recommendations. Ann Intern Med. 2008 Aug 5;149(3):I-37.
    Available from the [Annals of Internal Medicine Web
    site](http://www.annals.org/cgi/content/full/149/3/I-37).

-   Men: Stay Healthy at Any Age -- Checklist for Your Next Checkup.
    Rockville (MD): Agency for Healthcare Research and Quality. AHRQ
    Pub. No. 07-IP006-A. February 2007. Electronic copies: Available
    from the [USPSTF Web site](http://www.ahrq.gov/ppip/healthymen.htm).

Print copies: Available from the Agency for Healthcare Research and
Quality (AHRQ) Publications Clearinghouse. For more information, go to
<http://www.ahrq.gov/news/pubsix.htm> or call 1-800-358-9295 (U.S.
only).

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This summary was completed by ECRI on June 30, 1998. The information was
verified by the guideline developer on December 1, 1998. This summary
was updated on November 10, 2002. The information was verified by the
guideline developer on November 15, 2002. This NGC summary was updated
by ECRI Institute on July 28, 2008. The updated information was verified
by the guideline developer on August 13, 2008.

#### COPYRIGHT STATEMENT

Requests regarding copyright should be sent to: Randie A. Siegel,
Electronic Dissemination Advisor, Division of Print and Electronic
Publishing, Agency for Healthcare Research and Quality (formerly the
Agency for Health Care Policy and Research), 540 Gaither Road,
Rockville, MD 20850. Facsimile: 301-427-1873. E-mail:
<Randie.siegel@ahrq.hhs.gov>.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
site. Moreover, the views and opinions of developers or authors of
guidelines represented on this site do not necessarily state or reflect
those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or
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Readers with questions regarding guideline content are directed to
contact the guideline developer.

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© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008