Download Prostate Cancer - Toward Optimized Practice

Screening and Early Diagnosis of
Prostate Cancer
This guideline has been revised by the Toward
Optimized Practice-Prostate Cancer Access
Project ((TOP-PROCAP) Working Group and
is based on current scientific evidence. Due
to the evolving body of evidence related to
population based screening for prostate cancer,
this guideline will continue to be reviewed on a
biannual basis.
Issues
•
Although the mortality rates from prostate
cancer are declining, it is unclear whether
this decline is attributable to prostate specific
antigen (PSA) testing
•
PSA testing is critical in the ongoing
surveillance and management of men with
proven prostate cancer
•
The natural history of prostate pathology is
that most men with prostate cancer will die
with it rather than from it
Goals
•
To provide guidance about the appropriate
use of PSA testing
•
To help physicians and their patients make
informed decisions about the early diagnosis
of prostate cancer in asymptomatic men of
any age
Recommendations
There is increasing evidence to support the use
of PSA in making an earlier diagnosis of prostate
cancer.
•
We suggest men be advised of the
reliability of PSA testing, as well as the
potentialbenefits and risks of the test, as the
latter may occur if further investigations are
required
•
We suggest PSA testing be discussed with
the following asymptomatic individuals:
• Most men over 50 years of age1
• Men at higher risk for the development
of prostate cancer (family history of
prostate cancer*,2,5 or African-
Canadian descent3,4)
• Men who express a concern about the
development of prostate cancer
*What constitutes family history is somewhat
uncertain but it has been suggested as a
first degree relative with prostate cancer
diagnosed before age 65.*,2,5
•
The appropriate use of PSA testing can
include:
• Evaluation of a man with an abnormal
digital rectal examination (DRE)
• Evaluation of a man with lower urinary
tract symptoms (LUTS)
• Assisting in the early diagnosis of
prostate cancer in a man who has been
advised of the risks and benefits of the
tests and through shared-informed
decision making would like to proceed
with testing
• Follow-up of a man with prostate
cancer
• If proceeding with testing, then we suggest both
DRE and PSA be performed.
• DRE is not as sensitive as PSA,
however, DRE may provide useful
information:
i. Might identify some cancers missed by
PSA
ii. Might help decision-making regarding
referral
iii. Is useful in assessing the size of the
prostate and staging cancer if present
•
Please note that many of the associated
risks of PSA also apply to DRE (eg, false
positive)
•
Identified by urine cultures on two clean
catch specimens that are positive in a
resident who has no urinary tract infection
symptoms
Pratice Points
Until the laboratory requisitions in current use are
updated, family physicians wanting to order the
serum PSA should add the test to the requisition
form and indicate “medically
required” (no cost to the patient)
Utilization of the PSA as a screening procedure
or for the early diagnosis of prostate cancer is
inappropriate in men with a life expectancy of
less than 10 years
Background
Prostate cancer is the most common cancer
among Canadian men (excluding non melanoma
skin cancer). In 2010, an estimated 24 600 men
will be diagnosed with prostate cancer and 4300
will die of it. On average, 470 Canadian men
will be diagnosed with prostate cancer every
week. In Alberta, prostate cancer is the most
frequently diagnosed type of cancer for men; an
estimated 2500 Albertan males will be diagnosed
with prostate cancer in 2010.4 The probability of
developing prostate cancer is one in 7 men (the
highest risk comes after age 60). The probability
of dying from prostate cancer is one in 27.4
Role of PSA Testing
Mild elevations of PSA are frequently associated
with benign prostatic disease. For a given
individual there may be variations in PSA levels
independent of cancer.
PRACTICE POINT
PSA should not be measured in patients
with a confirmed acute urinary tract infection
(UTI), prostatitis, urinary retention or recent
catheterization.
Role of Dre
A suspicious DRE is an indication for serum
PSA testing and consideration of referral
to an Urologist. Please see Appendix A:
Recommendations for Referral of Patients with
Suspected Prostate Cancer.
PRACTICE POINT
An abnormality in either DRE or PSA should
trigger further assessment
Risk Factors for Prostate Cancer
Men at higher risk for the development of
prostate cancer are those with a family history
of prostate cancer or those of African Canadian
descent.3,6 What constitutes family history is
somewhat uncertain but it has been suggested
as a first degree relative with prostate cancer
diagnosed before age 65.2,7
Recommended Risk Adjusted Prostate
Specific Antigen (PSA) Cut-Off Values6
Age
(Years)
PSA Cut-Off
Values
(ng/ml)
AfricanCanadians
40-49
2.5
2.0
50-59
3.5
4.0
60-69
4.5
4.5
70-79
6.5
5.5
Assessment of Symptomatic Patients
In aging men, both benign prostatic hyperplasia
(BPH) and prostate cancer are common, and
often coexist. LUTS can be associated with both,
and warrant further investigation based on a
number of factors that may include age and life
expectancy of the patient. Some men with BPH
will have mildly elevated PSA levels, but the
possibility of a coexistent prostate cancer must
be kept in mind. Concepts such as age related
PSA values, which take into account some
PSA change with increasing (benign) prostate
enlargement, may be useful in determining
which patient should be considered for further
investigation. The most appropriate way to detect
prostate cancer in these men is a combination of
DRE and PSA. Transrectal ultrasound (TRUS)
of the prostate is not useful in the diagnosis of
prostate cancer. TRUS does however, provide an
excellent means of guiding transrectal biopsies of
the prostate.
Please see Appendix A: Recommendations for
Referral of Patients with Suspected Prostate
Cancer
Does an Increased PSA Mean Cancer?
In assessing the potential benefits of any
screening test the problems of false positive
results and the potential harm of testing and the
risks of treatment must also be evaluated. For
example, in men over 50, the positive predictive
value of a PSA>4.0 g/L is only 31%. (Although
PSA>4.0 g/L alone has a positive predictive
value of 31% if you add a positive DRE the
PPV increases to 49-72%).8 Many men with an
abnormal PSA will not have cancer. However,
before cancer is ruled out, these men must
undergo additional testing such as repeat PSA
testing, urology assessment and biopsy.
Interpretation of Prostate Specific
Antigen (PSA) Values9
PSA value
Interpretation
0.5-4.0 ng/mL
Normal
4-10 ng/mL
20% chance of cancer
>10 ng/mL
50%+ chance of cancer
Rise of >20%/year
Refer for biopsy
Previous Studies
The first two studies of prostate cancer screening
had important concerns that limit interpretation
and application to practice. In the first, 1 in every
6 males (1494 total) age 50-69 were randomly
selected from the entire population of 9026 males
in a municipality of Norrkoping, Sweden.10 The
remaining group (7532) served as the control.
Screening consisted of 4 rounds, 3 years apart.
In all four rounds, DRE was performed; in the first
round, a general practitioner and urologist
completed the exam and in subsequent rounds
the general practitioner completed the exam.
PSA was not done in the first 2 rounds but was
added in the last 2 rounds. Although long-term
follow-up was quoted as 15 years (1987-2003),
the PSA portion had follow-up of 10 years or less
(1993-2003). The study was designed as a pilot
to determine how to best design a screening
program. Prostate cancer mortality was 1.29% in
the screened group and 1.34% in the unscreened
group, with no statistical difference. Concerns
with this study are numerous. It was not a true
randomized controlled trial (only a portion was
randomized from a population), it was grossly
underpowered to show any difference in prostate
cancer mortality, and it used PSA only for second
half of the screening time. This study adds little
to our understanding of screening for prostate
cancer.
In the second study, all men aged 45-80 in the
Quebec City area (46 486) were randomized at
a ratio of 2 of every 3 males to an invitation for
screening (31 133) or no invitation (15 353).11
Of those invited to screening, only 7348 (23.6%)
agreed to participate and the remaining 23 785
(76.4%) did not have any screening. Screening
in the first year (1988) was DRE and PSA but
subsequent annual screening rounds included
only PSA (plus DRE if positive). The trial lasted
11 years (completed 1999). Of those not invited
for screening, 14 231 (92.7%) did not have any
screening and 1122 (7.3%) did receive some
screening. Therefore, the intention to treat
analysis would compare 31 133 men of whom
23.6% got some screening to 12 353 men of
whom 7.3% got some screening. The prostate
cancer mortality in the invited group was 153 of
31 133 men (0.49%) and in the not invited group
was 75 of 15,353 men (0.49%), with no statistical
difference (p=0.56). Using a per-protocol type
analysis, the prostate cancer mortality was 11
of 8470 men (0.13%) in the screened group and
217 of 38 016 men (0.57%) in the non-screened
group, a statistically significant difference
(p=0.0025) over 11 years. This would suggest a
number needed to screen of 228 over 11
years but the results are biased as the people
attending screening are likely different than those
not-attending screening and may have better
survival regardless of the screening. This study
is severely challenged by the fact that only 16%
more of the invited group received screening
compared to the not-invited group and more than
three quarters were not screened in the group
invited for screening.
Large National Studies of Prostate
Cancer Screening
In the last 2 years, our understanding of PSA
based prostate cancer screening has grown
considerably. The PLCO (Prostate, Lung,
Colorectal and Ovarian) study12 is a randomized
controlled trial of 76 693 men performed in 10
centers in the United States. Men, ages 5569 (mean 60.8), were randomized to annual
screening PSA tests for 6 years and DRE exams
for 4 years or no screening (control). PSA cut-
Related Prostate Screening Studies
In the last year, we have seen some of the
studies within ERSPC published and these
provided more understanding. The Göteborg
Sweden study14 is a randomized controlled
trial of 20 000 men performed in Göteborg
Sweden. Men, ages 50-64 (mean 56), were
randomized to PSA testing every 2 years (without
DRE) or no screening (control). PSA cutoff
for further work-up was 3 ng/mL (decreased to
2.5 ng/mL later). The trial was well designed
with blinding of mortality assessors, the use of
intention to treat analysis and randomization
from the population. Although randomization
of the population meant that only 76% of men
randomized to screening actually accepted
and attended any screening, this design would
be similar to broad screening invitations in an
unselected population. Although this was part
of the ERSPC study, it actually started before
ERSPC and joined later (so can be considered a
distinct study and not a subgroup). After 14 years
of follow-up, prostate cancer was diagnosed in
11.4% of those screened and 7.2% of those
in control. Prostate cancer death occurred in
0.5% of those screened compared to 0.9% of
those in control, rate ratio of 0.56 (CI 0.39-0.82).
The absolute difference in prostate cancer death
was 0.4% with a number needed to screen of
293 and number needed to treat of 12 to prevent
one prostate cancer death over 14 years. Low to
moderate risk prostate cancers represent 85%
of cancers found by screening and 62% in the
control. On first test, PSA results were <1 ng/
mL in 48%, 1-3 ng/mL in 39%, and >3 ng/mL
in 12.5% and at follow-up, prostate cancer was
diagnosed in those groups at 2.6%, 17.6%, and
45.5% respectively.
Another study compared the screened population
of the Netherlands portion of ERSPC with an
unscreened population in Ireland (94% versus
6% having had a PSA, respectively).15 Although
this is not a comparison of randomized subjects,
it supports the results of the ERSPC13 in general
and the longer trial of Göteborg.14 Over a
median followup of 8.5 years, prostate cancer
related death were 0.29% screened Netherlands
group versus 0.47% Irish control, for a statistically
significant (p=0.008) difference of 0.18%. This
equates to a number needed to screen of 555
and a number needed to treat of 37 to prevent
one prostate cancer death over 8.5 years.
A recent systematic review and meta-analysis of
prostate cancer screening has been published
reporting that screening results in no reduction
in prostate cancer mortality (0.88, 0.71 to 1.09;
P=0.25).16 The systematic review includes 6
studies but one was too short and does not
provide prostate cancer mortality data. The
remaining studies have been reviewed in this
document and include Norrkoping Sweden,10
Quebec City,11 PLCO,12 ERSPC13 and
Göteborg.14 The authors report that the prostate
cancer mortality results were “considerably
heterogeneous,” on statistical testing, meaning
the results were different between the studies. If
we look back on these studies, Norrkoping had
limitations including size, primarily DRE as
screening and not being truly randomized, so it
should likely not be included. In the case of
PLCO and Quebec studies, the difference in
percent actually screened between those
randomized to screening and no screening was
33% or less (85% versus 52% PLCO and 23.6%
versus 7.3% Quebec). Combining data like
this can serve only to confuse the situation, not
clarify it. It is preferable to look at these
studies individually.
Harms: What is the Dependability of our
Screening Tests?
Although we have significantly more data on the
benefits of prostate screening in
reducing prostate cancer death, we are missing
data on the associated harms of
screening.
The PLCO study found false positive rates were
5.4% for a single PSA and 6.4% for a
single DRE, which increased after 4 tests to
12.9% for PSA and 17.6% for DRE.17 That
means that after 4 tests, a false positive belief
that there is a prostate cancer when one
does not exist will occur for one in every 8 men
from PSA testing and one in every 6 men
from DRE. The Finnish section of the ERSPC
study examined PSA results over varying ages
and rounds of testing.18 Using a cut-off of ≥4 ng/
mL, positive PSA results occurred in 4.8%
at age 55, 7.5% at age 59, 12.4% at age 63 and
16.5% at age 67. The proportion of true positives
(biopsy confirmed cancers) to false positives
(elevated PSA with no cancer on biopsy)
remained relatively consistent at approximately
30% versus 70%, respectively.
From age 55 to 67, prostate cancer increased
from 1.2% to 4.5% while the false positive
rate also increased from 3.3% to 11.1%.17 Of
those with a false positive PSA result, greater
than 50% of patients will have another false
positive PSA result. Men with an initial false
positive are also more likely to have prostate
cancer identified in subsequent testing
rounds; 12.3%-19.7% compared to 1.4%-3.7%
for those with negative PSA test.17 The
impact of false positives on future investigations
is mixed with one study showing men
1.5-2 times less likely to return for subsequent
screening17 while other studies show men
with false positives were more likely to have
urologic follow-up tests and visits.18 Up to
one year after testing, more men with false
positive results worry about prostate cancer
than men with negative results (26% versus 6%,
p<0.001).19 In a previous study, 37% of positive
age-specific PSA tests were in the normal range
on the next test 1 year later.20 A more recent
study found 40% of positive PSA (cut-off ≥4.0 ng/
mL) tests returned to normal after 1 year. The
authors suggest that repeat testing might be
helpful but say the timing would vary from a few
weeks to 6 months later, based on a decision by
patient and clinician concern arising from clinical
characteristics of each case.5 To confirm a
positive test and reduce the risk of false positive,
repeat testing in 3-6 months is frequently
advocated, but this should be influenced by
clinical concerns and the decision to retest
could be much sooner. PSA, depending on age
and normal range used, carries about a 1%
risk of being false negative (or negative test
result when the patient does truly have prostate
cancer).20
Harms: What are the Risks of a Work-up
for a Positive Screen?
The PLCO study12 reports 0.7% of patients
had complications (infection, bleeding, clots and
urinary difficulties) associated with the work-up
of positive screening. In the Rotterdam section
of the ERSPC, 5802 biopsies were performed
between 1994 and 2001.21 Minor complications
rates were 23% for hematuria of >3 days or 50%
for hematospermia. Major complications included
pain after biopsy (7.5%, with 6% of them
requiring analgesia), fever (3.5% with 94% of
them receiving antibiotics), hospitalization (0.5%),
and urinary retention (0.4%). This information
is difficult to weigh and put in context of other
screening maneuvers (see below).
How Does Prostate Cancer Screening
Compare with other Screening?
It may be helpful to compare some of these
numbers to other common screening maneuvers.
Mammography22 has a number needed to screen
of 1235 or 614 for 7 or 13 years, respectively, to
prevent one breast cancer death in women ≥50
years of age. Screening for colon cancer with
fecal occult blood testing23 has a number needed
to screen of 617 over 12-18 years to prevent one
colorectal cancer death.
The evidence for the DRE in prostate screening
is less robust. As noted below, DRE has
false positive rates at least as high as PSA
testing. ERSPC13 and the Göteborg14
demonstrated benefit in prostate cancer mortality
but screening was generally the offer of PSA
without DRE in screening. However, in the
Rotterdam section of the ERSPC, 17% of the
cancers identified by screening were picked up
with DRE while the PSA was below4 ng/mL.24
Fortunately, modeling of screening outcomes has
been done for both mammography25 and PSA
testing.24 The applications of these models are
limited by the large number of assumptions and
combination of different studies, but they do allow
for basic comparisons. Of 1,000 women screened
for 10 years with mammography at age 60, 185
will be recalled for more investigations, 56 will
receive a biopsy, 38 will be diagnosed with breast
cancer and 5 will die from it. In the unscreened
group, 24 will be diagnosed with breast cancer
and 8 will die from it.25 Of 1000 men screened
for 10 years with PSA at age 60, 115 will have
an abnormal PSA and receive a biopsy, 53 will
be diagnosed with prostate cancer and 3.5 will
die from it. In the unscreened group, 23 will be
diagnosed with prostate cancer and 4.4 will die
from it. Although mortality reductions appear
worse, prostate disease is slower and longer
modeling may be required. As noted above, the
number needed to screen at years beyond 10 is
very similar for mammogram and prostate. That
said, the harms of a work-up are likely higher
in prostate cancer screening. Breast biopsy,
particularly core-needle biopsy 26 seems to
be associated with fewer adverse events than
prostate biopsy. For example, infections requiring
antibiotics occur in 0.15% of core-needle breast
biopsies compared to 3.3% of prostate biopsies.
What are the Complications Related to
the Treatment of Prostate Cancer?
The quality of life impacts and risks of prostate
cancer management (including radical
prostatectomy and/or radiotherapy) are
incontinence, urethral stricture, bowel damage,
erectile dysfunction, as well as complications
arising from anesthesia and major surgery,
including death.27 Screening patients will identify
cancer that may never have manifested
clinically. These patients will not benefit from
treatment but are subject to the potential
risk associated with treatment. Although we
are moving towards differentiating patients with
clinically meaningful cancer from those with little
or no clinical risk, this is still uncertain. Balancing
these issues is part of the overall challenge of
screening. We look forward to the continued
publication of results of the European and PLCO
studies on quality of life, which may help us
to further understand the risks and benefits of
prostate cancer screening.
Advice to Patients
The TOP-PROCAP Working Group supports the
rights of patients to make informed decisions
about their health care options. Patient education
is paramount in decisions surrounding prostate
cancer. It is important for the asymptomatic man
to be aware of the consequences of his decision
to be screened or not.
Patient decisions will vary as a result of individual
concerns of cancer, individual interpretation of
the evidence related to benefits and risks along
with consideration for the impact of procedures
that may be recommended following an abnormal
result.
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For those interested in more details regarding
prostate cancer screening, benefits and risks, the
American Cancer Society Guideline provides an
excellent detailed review.28
More Information
For full guideline and summary, please see the
Clinical Practice Guideline for Screening
and Early Diagnosis of Prostate Cancer at the
TOP web site: http://www.topalbertadoctors.org/
informed_practice/cpgs/prostate_cancer.html
2010 prostate guideline revisions were completed
by the Toward Optimized Practice- Prostate
Cancer Access Project (TOP-PROCAP) Working
Group.
Suggested Citation:
Toward Optimized Practice-Prostate Cancer
Access Project (TOP-PROCAP) Working Group.
Clinical practice guideline for screening and early
diagnosis of prostate cancer. Edmonton,
AB: Toward Optimized Practice. 2010. Available
from: http://www.topalbertadoctors.org/
informed_practice/cpgs/prostate_cancer.html
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