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1 28 Jan 2007

28 Jan 20071. 2 Associate Professor Family and Community Medicine Department King Saud University By Screening for Prostate Cancer

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1 28 Jan 2007

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.

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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.

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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?

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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.

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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.

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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.”

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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.”

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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.

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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.

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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.

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Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6565

Questions?Questions?

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Prostate Cancer Prostate Cancer ScreeningScreeningDr. S. TayelDr. S. Tayel 6666

ThanThank youk [email protected]

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