View
215
Download
2
Tags:
Embed Size (px)
Citation preview
2 28 Jan 2007
Associate Professor Associate Professor Family and Community Medicine DepartmentFamily and Community Medicine Department
King Saud UniversityKing Saud University
ByBy
Screening for Prostate CancerScreening for Prostate Cancer
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 33
All men over 50 years All men over 50 years should be screenedshould be screened
Not recommended Not recommended to be screenedto be screened
The controversyThe controversy
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 44
Please WaitPlease Wait…...…...
Before making a decision whether Before making a decision whether
to be screened for prostate to be screened for prostate
cancer…..cancer…..
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 55
Learning ObjectivesLearning Objectives
At the end of this presentation you (will) be able:At the end of this presentation you (will) be able:
To explain the risk of prostate cancer.To explain the risk of prostate cancer.
To review the evidence of benefits and harms of To review the evidence of benefits and harms of
screening for prostate cancer.screening for prostate cancer.
To discuss the recommendations and policy options To discuss the recommendations and policy options
of 2006 conference about prostate cancer screening.of 2006 conference about prostate cancer screening.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 66
Performance ObjectivesPerformance Objectives
At the end of this presentation you (will) be able:At the end of this presentation you (will) be able:
To make a decision whether to be screened for To make a decision whether to be screened for
prostate cancer.prostate cancer.
To help your patients to make their decision about To help your patients to make their decision about
screening for prostate cancer.screening for prostate cancer.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 77
Lifetime risk:Lifetime risk:
Risk of Diagnosis
164 (per 1,000 men) ≈ 16% (1 in 6 men)
Risk of Death
34 (per 1,000 men) ≈ 3% (1 in 33men)
What is the risk of prostate cancer?What is the risk of prostate cancer?
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 88
Risk of Death for 40 year old U.S. Men, to End Risk of Death for 40 year old U.S. Men, to End of Life, by Leading Causesof Life, by Leading Causes
34
341
38
80
62
55
0 50 100 150 200 250 300 350
Prostate Cancer
Pneumonia &Influenza
Chronic ObstructivePulmonary Disease
Stroke
Lung Cancer
Heart Disease
Number of Men per 1,000Number of Men per 1,000
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 99
Risk Factors for Prostate CancerRisk Factors for Prostate Cancer
KnownKnown risk factors for developing prostate cancer: risk factors for developing prostate cancer:• Age.Age.• Race/ethnicity (African American).Race/ethnicity (African American).• Family history (who has a father or a brother with Family history (who has a father or a brother with
prostate cancer has two to three times greater risk)prostate cancer has two to three times greater risk)
All are All are non-modifiablenon-modifiable risk factors. risk factors.
No agreement on modifiable risk factors.No agreement on modifiable risk factors.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1010
SummarySummary
Prostate cancer is a leading cause of death.
Prostate cancer risk increases with
Age, some racial/ethnic groups and in men with positive
family history.
There are no agreed-on strategies for primary
prevention for prostate cancer.
Screening has been considered as a possible
intervention to reduce the number of deaths.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1111
Question?Question?
Is Prostate Cancer a disease Is Prostate Cancer a disease suitable for screening?suitable for screening?
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1212
Criteria for selecting diseases suitable for Criteria for selecting diseases suitable for screening (4 WHO criteria)screening (4 WHO criteria)
1.1. The disease should be an The disease should be an obvious burdenobvious burden in terms of: in terms of:
death, suffering, economic or social costs.death, suffering, economic or social costs.
2.2. The The natural historynatural history of the disease should be well- of the disease should be well-
known and can be detected by appropriate tests. known and can be detected by appropriate tests.
An appropriate testAn appropriate test should be highly sensitive and should be highly sensitive and
specific for the disease as well as being acceptable specific for the disease as well as being acceptable
to the persons screened.to the persons screened.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1313
Criteria for selecting diseases suitable for screening
3. 3. Adequate diagnosis and treatmentAdequate diagnosis and treatment is available. is available.
AdequacyAdequacy is determined by: is determined by:
• proven medical effectproven medical effect
• ethical and legal acceptability. ethical and legal acceptability.
4. 4. Improvement of prognosisImprovement of prognosis by screening should by screening should
be better than spontaneous presentation.be better than spontaneous presentation.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1414
1. Burden of disease1. Burden of disease Prostate cancer is the second cause of male cancer Prostate cancer is the second cause of male cancer
deaths (after lung cancer). deaths (after lung cancer). Prostate cancer is a major cause of death among men, Prostate cancer is a major cause of death among men, with over with over 56,000 deaths56,000 deaths in the in the European UnionEuropean Union in 1998 in 1998 and and 30,44630,446 deaths in deaths in United StatesUnited States in 2002in 2002 This number of deaths would satisfy the first of the four This number of deaths would satisfy the first of the four
criteria for introducing a screening program criteria for introducing a screening program ((burden of burden of diseasedisease))..
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1515
2. The natural history of the 2. The natural history of the
disease and disease and
the screening teststhe screening tests
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1616
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1717
The natural historyThe natural history
The natural course of prostate cancer may appear The natural course of prostate cancer may appear
progressive and sometimes life threatening. Why?progressive and sometimes life threatening. Why?
Most epidemiological studies are based on selected Most epidemiological studies are based on selected
hospitalized cases from the tip of the iceberg.hospitalized cases from the tip of the iceberg.
Hospitalized cases usually have multiple health Hospitalized cases usually have multiple health
problems (CVD, DM).problems (CVD, DM).
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1818
The pyramid and iceberg of diseaseThe pyramid and iceberg of disease
11 Diseased, diagnosed & controlledDiseased, diagnosed & controlled
22 Diagnosed, uncontrolledDiagnosed, uncontrolled
33 Undiagnosed or wronglyUndiagnosed or wronglydiagnosed diseasediagnosed disease
44 Risk factors for diseaseRisk factors for disease
55 Free of risk factors Free of risk factors
Diagnosed Diagnosed diseasedisease
Undiagnosed orUndiagnosed orwrongly diagnosed diseasewrongly diagnosed disease
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 1919
Natural History of Prostate CancerNatural History of Prostate Cancer
Prostate cancer is biologically Prostate cancer is biologically heterogeneousheterogeneous..
Some prostate cancers Some prostate cancers grow slowlygrow slowly and has a long pre- and has a long pre-clinical phase.clinical phase.This long latent phase is potentially advantageous for This long latent phase is potentially advantageous for
screening.screening. Some tumours are Some tumours are very slow-growingvery slow-growing and may never and may never
become clinically important.become clinically important.Men with these tumours often die from another cause.Men with these tumours often die from another cause.
Other prostate cancers are Other prostate cancers are fast growingfast growing and metastasize and metastasize quickly.quickly.
Other types grow at a Other types grow at a modestmodest rate. rate.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2020
Natural History is an area of great uncertainty in Natural History is an area of great uncertainty in
prostate cancer screening. Why?prostate cancer screening. Why?
Screening is more likely to detect:Screening is more likely to detect:
Slowly progressiveSlowly progressive tumours that would have a better tumours that would have a better
overall prognosis regardless of any effects of early overall prognosis regardless of any effects of early
treatment.treatment.
Very Slowly progressiveVery Slowly progressive tumours that never becomes a tumours that never becomes a
real problem in a man’s life. (real problem in a man’s life. (Un-necessaryUn-necessary treatment) treatment)
Implication from natural historyImplication from natural history
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2121
b) The screening testsb) The screening tests
There are two tests used in mass screening for prostate cancer:There are two tests used in mass screening for prostate cancer: PSA (prostate specific antigen)PSA (prostate specific antigen) DRE (digital rectal examination)DRE (digital rectal examination)
The PSA test is simple, The PSA test is simple, cheap?cheap?,, safe and acceptable. safe and acceptable.
But with questionable But with questionable accuracyaccuracy. . Digital rectal examination is less acceptable and less sensitive Digital rectal examination is less acceptable and less sensitive
than PSA.than PSA. The prostatic biopsy, required to investigate positive results isThe prostatic biopsy, required to investigate positive results is
less acceptable and less acceptable and with significant risks.with significant risks.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2222
Benefits of ScreeningBenefits of Screening
Early DetectionEarly Detection PSA can detect prostate cancers 3 to 12 PSA can detect prostate cancers 3 to 12
years before they would have been detected years before they would have been detected clinically.clinically.
But!!!But!!!
Is early detection enough?Is early detection enough?
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2323
Death from prostate cancer
Symptoms Appear
Situation 1: Not Screened
Survival Time
Situation 2
Survival Time
Situation 3
Survival Time
Death
= Lead Time = Life Extended
Found Early by Screening
Situation 2
Found Early by Screening
Finding Prostate Cancer Earlier Is Finding Prostate Cancer Earlier Is Not EnoughNot Enough
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2424
Accuracy of PSAAccuracy of PSA
The The sensitivitysensitivity of PSA ranges between of PSA ranges between 72-90%72-90%
The The specificityspecificity ranges between ranges between 59-98% (not high)59-98% (not high)
Results of screening 100 asymptomatic men over fifty with PSAResults of screening 100 asymptomatic men over fifty with PSA::
Ten (10) will have a positive test. Ten (10) will have a positive test.
After biopsy, After biopsy, threethree will have prostate cancer (True Positive) will have prostate cancer (True Positive)
Seven (7/10) will not have prostate cancer (False Positive).Seven (7/10) will not have prostate cancer (False Positive).
Of the 90 men with a normal PSA, one or two (10-30%) will be Of the 90 men with a normal PSA, one or two (10-30%) will be
found to have prostate cancer (False Negative test).found to have prostate cancer (False Negative test).
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2525
Results of screening 100 men for prostate cancer Results of screening 100 men for prostate cancer
using (PSA)using (PSA)
Screening test Screening test
(PSA)(PSA)
Gold standardGold standard
(Prostatic biopsy)(Prostatic biopsy)TotalTotal
CancerCancerNo cancerNo cancer
PositivePositive3 3 (TP)(TP)7 7 (FP)(FP)1010NegativeNegative2 2 (FN)(FN)88 88 (TN)(TN)9090
TotalTotal559595100100
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2626
False PositivesFalse Positives
Age Age
(in years)(in years)
# With # With
PSA >4.0PSA >4.0
# With # With
CancerCancer
# False # False
PositivesPositives
50s50s551–21–23–43–4
60s60s15153–53–510–1210–12
70s70s2727991818
Of 100 unscreened men in each group
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2727
Results of mass screening for prostate cancer Results of mass screening for prostate cancer
using (PSA)using (PSA)
Screening test Screening test
(PSA)(PSA)
Gold standardGold standard
(Prostatic biopsy)(Prostatic biopsy)TotalTotal
CancerCancerNo cancerNo cancer
PositivePositive3300007700001.01.00000NegativeNegative220000888800009.09.00000
TotalTotal5500009595000010.010.00000
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2828
Limitations:Limitations:
Actually, data are only available on persons who Actually, data are only available on persons who
screen positive and are referred for further testing.screen positive and are referred for further testing.
ddcc
bbaaData are available for cells “a” and Data are available for cells “a” and “b” only. “b” only.
Permits calculation of PV+ onlyPermits calculation of PV+ only
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 2929
FalseFalse positivespositives are common due to low specificity of PSA. are common due to low specificity of PSA.
PSA levels increase in:PSA levels increase in:
ProstateProstate cancercancer
Benign enlargement of prostate (BPH)Benign enlargement of prostate (BPH)
Prostate infectionProstate infection
Risks of PSA screening:Risks of PSA screening:False positivesFalse positives
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3030
Harms of False Positives:Harms of False Positives:
Anxiety of being told as probably having the disease.Anxiety of being told as probably having the disease. Fear of future screening tests.Fear of future screening tests. Inconvenience and potential hazards of prostatic biopsy.Inconvenience and potential hazards of prostatic biopsy. Unnecessary investigation which increases the cost.Unnecessary investigation which increases the cost.
***Assure patients if they have positive screening results with ***Assure patients if they have positive screening results with
PSA that most of them PSA that most of them will will notnot be cancer be cancer..
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3131
Screening may detect cancers that would never have Screening may detect cancers that would never have
become clinically apparent in a man’s lifetime.become clinically apparent in a man’s lifetime.
Autopsy studies indicate that prostate cancer is present in Autopsy studies indicate that prostate cancer is present in
nearly half of older men. (men die with P.C. not from it)nearly half of older men. (men die with P.C. not from it)
Over-diagnosis leads to unnecessary treatments with their Over-diagnosis leads to unnecessary treatments with their
potential side effects.potential side effects.
Risks of PSA screening:Risks of PSA screening:Over-diagnosisOver-diagnosis
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3232
Prostate Cancer Trends in Incidence and Prostate Cancer Trends in Incidence and Mortality, 1973–1999Mortality, 1973–1999
0
50
100
150
200
250
1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999
Year
Incidence Mortality
Ra
te
pe
r 1
00
,00
0
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3333
Prostate Cancer Incidence Rates Prostate Cancer Incidence Rates by Stage, 1973–1995by Stage, 1973–1995
0
20
40
60
80
100
120
1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995Year of Diagnosis
Ra
te p
er
10
0,0
00
Distant Unstaged
Regional
Localized
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3434
Prostate cancer is Prostate cancer is heterogeneous heterogeneous (varies in severity)(varies in severity)
PSA can detect prostate cancers PSA can detect prostate cancers earlierearlier, ,
but early detection is not enough unless coupled with but early detection is not enough unless coupled with improvement of treatment. improvement of treatment.
False positives are False positives are common.common.
PSA cannot differentiate between fatal and harmless PSA cannot differentiate between fatal and harmless tumours with the risk of tumours with the risk of over-diagnosis.over-diagnosis.
SummarySummary
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3535
3. Adequate Diagnosis and 3. Adequate Diagnosis and TreatmentTreatment
Facilities for diagnosis and appropriate Facilities for diagnosis and appropriate
treatments should be available for treatments should be available for
individuals who screen positive.individuals who screen positive.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3636
Diagnosis and TreatmentDiagnosis and Treatment
The diagnostic test. The diagnostic test. The prostatic biopsy is available but:The prostatic biopsy is available but:
less acceptable & with significant risks.less acceptable & with significant risks.
The treatments available areThe treatments available are::
Radical prostatectomy (surgery), Radical prostatectomy (surgery),
RadiotherapyRadiotherapy
Androgen-deprivation therapy Androgen-deprivation therapy
““watchful waiting” or “active monitoring”:watchful waiting” or “active monitoring”:
men are followed up and only treated if there is evidence of men are followed up and only treated if there is evidence of
disease progression. disease progression.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3737
Excellent survival has been reported from several Excellent survival has been reported from several case-seriescase-series
studies of men treated with surgery or radiation for early-stage studies of men treated with surgery or radiation for early-stage
prostate cancer.prostate cancer. Watchful waiting can produce survival rates Watchful waiting can produce survival rates similarsimilar to those of to those of
more aggressive treatment more aggressive treatment
• A study of 800 men who chose watchful waiting found the A study of 800 men who chose watchful waiting found the
10-year disease-specific survival to be 87%.10-year disease-specific survival to be 87%.
Only one large, Only one large, randomized controlled trialrandomized controlled trial has been has been
completed that compares treatment of clinically localized completed that compares treatment of clinically localized
prostate cancer.prostate cancer.
Treatment effectivenessTreatment effectiveness
38
Risk of Mortality From Prostate Cancer Among Men in a Randomized Trial
PROSTATE REMOVED WATCHFUL WAITING
7.1% died of prostate cancer 14.9% died of other causes
13.6% died of prostate cancer14.7% died of other causes
Average age 65 years at entry; 8 years followup
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 3939
RiskRiskRadical
prostatectomy Radiotherapy
Androgen
deprivation therapy
Watchful
waiting
Erectile Erectile
dysfunctiondysfunction20–20–79.6%* 20–45%20–45%20–70%20–70%30%30%
Urinary Urinary
IncontinenceIncontinence 15–50%15–50%2–16%2–16%
Hot flushes Hot flushes
50–60%50–60%------------
** The rate varies according to experience. The rate varies according to experience.
Side Effects of TreatmentSide Effects of Treatment
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4040
CostsCosts
1.1. Cost of applying the screening test (PSA).Cost of applying the screening test (PSA).
2.2. Cost of performing prostate biopsy on people who Cost of performing prostate biopsy on people who
screen positive (The majority are F.P.)screen positive (The majority are F.P.)
3.3. Cost of un-necessary treatment due to over-Cost of un-necessary treatment due to over-
diagnosis.diagnosis.
4.4. Cost of re-screening Cost of re-screening annuallyannually. .
Case-finding should be a continuous process, Case-finding should be a continuous process,
not just a “once and for all” projectnot just a “once and for all” project..
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4141
CostsCosts
Cost effectiveness analysis:Cost effectiveness analysis:
The concept of The concept of Number Needed to ScreenNumber Needed to Screen
““How many men must be screened to save How many men must be screened to save oneone life from life from
prostate cancer?”prostate cancer?”
Health care Health care resourcesresources are are limitedlimited in many countries. in many countries.
The potential harm to other people by The potential harm to other people by divertingdiverting resources resources
away from other (effective) technologies.away from other (effective) technologies.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4242
SummarySummary
The prostatic biopsy is available but with hazards.The prostatic biopsy is available but with hazards.
Treatment gives excellent results but Treatment gives excellent results but similar to
watchful waiting.
Treatment side effects Treatment side effects are fairly common.
The program is of The program is of relatively high costs.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4343
4. Effectiveness of screening 4. Effectiveness of screening programprogram
Does screening reduce prostate cancer Does screening reduce prostate cancer mortalitymortality
and and extend men’s livesextend men’s lives
Compared to spontaneous presentation?Compared to spontaneous presentation?
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4444
Ecological Ecological (Correlational) studies(Correlational) studies
EcologicalEcological studiesstudies describe the relationship between describe the relationship between
national mortality trendsnational mortality trends and the uptake of and the uptake of PSAPSA
screeningscreening for several populations or for several populations or
for the same population at different times.for the same population at different times.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4545
What Happened to U.S. Prostate Cancer What Happened to U.S. Prostate Cancer Mortality Rates as Screening Rates Increased?Mortality Rates as Screening Rates Increased?
0
10
20
30
40
1973 1975 1977 1979 1981 1983 1985 1987 1989 1991 1993 1995 1997 1999Year
Ra
te p
er
10
0,0
00
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4646
Prostate Cancer Mortality Rates in the U.K. Prostate Cancer Mortality Rates in the U.K. (PSA Screening Is Rare)(PSA Screening Is Rare)
0
10
20
30
40
50
60
70
1979 1981 1983 1985 1987 1989 1991 1993 1995 1997Year
Ra
te p
er 1
00,0
00
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4747
Ecological studiesEcological studies
InconsistenciesInconsistencies in the relationship between national mortality in the relationship between national mortality
trends and the uptake of PSA screening. trends and the uptake of PSA screening.
Even with the reduction in U.S. prostate cancer mortality, It is Even with the reduction in U.S. prostate cancer mortality, It is
difficult to conclude that it is due to PSA screening. Why?difficult to conclude that it is due to PSA screening. Why?
These decreases occurred These decreases occurred soonersooner after the introduction of after the introduction of
screening than expectedscreening than expected
Mortality may be affected by other factors such as improved Mortality may be affected by other factors such as improved
treatmenttreatment of prostate cancer. of prostate cancer.
Ecological Fallacy.Ecological Fallacy.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4848
They usually over-estimate the benefits of screening programs.They usually over-estimate the benefits of screening programs.
Sources of bias:Sources of bias:
1. Self-selection bias (volunteer bias)1. Self-selection bias (volunteer bias)
2.2. Lead time biasLead time bias
3. Length bias3. Length bias
4. Over-diagnosis bias4. Over-diagnosis bias
Analytic studies (Case-Control and Cohort)Analytic studies (Case-Control and Cohort)
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 4949
Randomized Controlled Trials (RCTs)Randomized Controlled Trials (RCTs)
RCT is the best solution to overcome effects of all RCT is the best solution to overcome effects of all
forms of biases.forms of biases.
It should be:It should be: Too large sample size.Too large sample size.
Too long time.Too long time.
Too strict criteria.Too strict criteria.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5050
Prostate cancer screening RCTsProstate cancer screening RCTs
There are two major randomized controlled trials of screening:There are two major randomized controlled trials of screening:
The European StudyThe European Study for Screening of Prostate Cancer was for Screening of Prostate Cancer was
planned to recruit 190 000 menplanned to recruit 190 000 men. (2008). (2008)
In the United StatesIn the United States (The Prostate, Lung, Colorectal and (The Prostate, Lung, Colorectal and
Ovarian Cancer Screening Trial (PLCO) completed Ovarian Cancer Screening Trial (PLCO) completed
recruitment of over 150 000 participants and will follow them recruitment of over 150 000 participants and will follow them
for up to 14 years (2014) for up to 14 years (2014)
Upon completion, both trials are anticipated to provide level I Upon completion, both trials are anticipated to provide level I
evidence about the benefits of PSA screening.evidence about the benefits of PSA screening.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5151
SummarySummary
It remains unclear whether mass screening does It remains unclear whether mass screening does
actually improve prognosis compared to actually improve prognosis compared to
spontaneous presentation. spontaneous presentation.
Effectiveness of screening program can only be Effectiveness of screening program can only be
answered by RCTs.answered by RCTs.
Results of RCTs are expected in 5 to 10 years.Results of RCTs are expected in 5 to 10 years.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5252
• PSA screening detects cancers earlier but not enough.
• Improved prognosis for someImproved prognosis for some PSA-detected cancers but similar to watchful waiting.
• PSA may contribute to the declining death rate but we are uncertain. (Ecological fallacy)
•
• False positives are common.Anxiety and unnecessary biopsy Anxiety and unnecessary biopsy
• Over-diagnosis is a problem
(Over-treatment of uncertain Over-treatment of uncertain abnormalities)abnormalities)
• Treatment-related side effects are fairly common.
Potential Benefits
Potential Harms
BenefitsBenefits and and risksrisks of prostate cancer screening of prostate cancer screening
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5353
ConclusionConclusion The evidence suggests that only the first of the four WHO criteria for The evidence suggests that only the first of the four WHO criteria for
diseases suitable for screening (diseases suitable for screening (Disease burdenDisease burden) is satisfied.) is satisfied.
There are many areas of uncertainty about prostate cancer screening:There are many areas of uncertainty about prostate cancer screening:
the natural history of the disease, which appears relatively benignthe natural history of the disease, which appears relatively benign
the relative harm arising from treatment andthe relative harm arising from treatment and
the uncertainty over the best treatment for screen-detected cancer. the uncertainty over the best treatment for screen-detected cancer.
For all these reasons of For all these reasons of uncertaintyuncertainty, it is unethical to invite healthy people , it is unethical to invite healthy people
and subjecting them to inconvenience and potential hazards of and subjecting them to inconvenience and potential hazards of
screening unless there is conclusive evidence that they could benefit.screening unless there is conclusive evidence that they could benefit.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5454
Recommendation of Prostate Cancer Recommendation of Prostate Cancer Conference (August 2006)Conference (August 2006)
Until the evidence of effectiveness of PSA screening emerges, Until the evidence of effectiveness of PSA screening emerges, Most medical organizations recommend that:Most medical organizations recommend that: National policy makers should not support mass-screening National policy makers should not support mass-screening
programs. programs. Clinicians should be informed of the uncertainty surrounding Clinicians should be informed of the uncertainty surrounding
PSA.PSA. Clinicians can handle the screening issue by:Clinicians can handle the screening issue by:
Providing information about the pros and cons of screening.Providing information about the pros and cons of screening.
Involving patients in making the best decision according to Involving patients in making the best decision according to their values and preferences using their values and preferences using shared decision makingshared decision making..
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5555
Shared Decision MakingShared Decision Making
Shared decision making means:Shared decision making means:
Encouraging a patient to participate in the Encouraging a patient to participate in the
decision.decision.
Helping a patient consider how the evidence Helping a patient consider how the evidence
fits his values and preferences.fits his values and preferences.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5656
What Is the Best Way To Use What Is the Best Way To Use Shared Decision Making?Shared Decision Making?
The key elements for Shared Decision Making :The key elements for Shared Decision Making :
1.1. Provide information: Use decision aids.Provide information: Use decision aids.
2.2. Discuss questions and concerns.Discuss questions and concerns.
3.3. Discuss why men choose different options.Discuss why men choose different options.
4.4. Listen and make a joint decision.Listen and make a joint decision.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5757
InformingInforming Patients Patients
Do I know the potential benefits?
Do I know the possible harms?
Do I know the likelihood of
various outcomes?
Do I know the potential
consequences of my decisions?
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5858
Use Decision Aids To Help in Use Decision Aids To Help in Shared Decision MakingShared Decision Making
Types of decision aids:Types of decision aids:
Pamphlets, videos, Web-based formats.Pamphlets, videos, Web-based formats.
They are available at www.cdc.gov/cancer/prostate.They are available at www.cdc.gov/cancer/prostate.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 5959
2. Discuss His Questions and Concerns2. Discuss His Questions and Concerns
Address misconceptions.Address misconceptions.
Give him time to think.Give him time to think.
Use more than one visit, if needed.Use more than one visit, if needed.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6060
3. Discuss Why Men Choose Different Options3. Discuss Why Men Choose Different Options
Patient who decided to be screened:Patient who decided to be screened:
““I will take the screening testsI will take the screening tests because they will because they will
give me peace of mind. give me peace of mind.
If I have cancer, I want it is found early when If I have cancer, I want it is found early when
treatments might be more effective.treatments might be more effective.
Even if it saves one life, it is worth all of the Even if it saves one life, it is worth all of the
possible side effects of treatment.”possible side effects of treatment.”
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6161
Patient who chose not to be screened:Patient who chose not to be screened: ““I will not take the screening tests until medical I will not take the screening tests until medical
experts agree that finding and treating prostate experts agree that finding and treating prostate cancer in its early stages reduce the chance of cancer in its early stages reduce the chance of dying from it. dying from it.
Screening tests could lead to further tests and Screening tests could lead to further tests and treatment of a prostate cancer that may never treatment of a prostate cancer that may never cause problems. cause problems.
And treatment can have serious side effects.And treatment can have serious side effects. I think I’ll wait until we know more.”I think I’ll wait until we know more.”
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6262
4. Listen and Make a Joint Decision4. Listen and Make a Joint Decision
If he is ready to choose, accept and support his If he is ready to choose, accept and support his decision.decision.
If he is not ready, put the decision off until the next If he is not ready, put the decision off until the next visit.visit.
If he asks what you would choose, tell him you If he asks what you would choose, tell him you know men who have chosen both options.know men who have chosen both options.
If he is unable or does not want to make a decision, If he is unable or does not want to make a decision, give him your recommendation.give him your recommendation.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6363
SummarySummary Shared decision making is the best current Shared decision making is the best current
answer because:answer because: There is some evidence that screening may extend There is some evidence that screening may extend
men’s lives, but the evidence is not conclusive.men’s lives, but the evidence is not conclusive.
Some men suffer harms from screening.Some men suffer harms from screening.
How men weigh potential harms and benefits depends How men weigh potential harms and benefits depends
on the individual values and preferences.on the individual values and preferences.
Our challenge:Our challenge:• To find ways to help men make their own decisions.To find ways to help men make their own decisions.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6464
At the end…………At the end…………I hope we could:I hope we could:
Illustrate the controversy about prostate cancer screening.Illustrate the controversy about prostate cancer screening.
Portray the evidence of benefits and harms of screening for Portray the evidence of benefits and harms of screening for
prostate cancer.prostate cancer.
Recognize the recommendations and policy options of 2006 Recognize the recommendations and policy options of 2006
conference about prostate cancer screening.conference about prostate cancer screening.
Discuss how clinicians can use shared decision making to Discuss how clinicians can use shared decision making to
help patients decide whether to be screened for prostate help patients decide whether to be screened for prostate
cancer.cancer.
Help you decide whether to be screened for prostate cancer.Help you decide whether to be screened for prostate cancer.
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6565
Questions?Questions?
28 Jan 200728 Jan 2007
Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6666
ThanThank youk [email protected]
Bibliotheca Alexandrina