84 I KENYA NATIONAL CANCER SCREENING GUIDELINES
PROSTATE CANCER SCREENING
Prostate Cancer burden
Prostate cancer is the fourth leading cancer in incidence globally, with higher mortality
reported in less developed regions than in more developed regions. Prostate cancer is
a disease of the aging male, the majority presenting after 65 years (average of 68 years).
This is the most common cancer among elderly male population all over the world, with
a slight preponderance in blacks. Incidentally autopsy prevalence rates of prostate can-
cer are the same across all races suggesting environmental factors play a crucial role in
aetiology. This compares well with.
In Kenya, prostate cancer is the commonest cancer in males with 2,864 new cases (14.9%) (GLOBOCAN, 2018). Currently, the proportion of men diagnosed with prostate cancer by age is as tabulated below:
|Age of Men in Years||Percentage proportion|
Source: KNH Cancer Registry, 2018: Prostate cancer new cases %
Studies have shown that compared with other countries, patients with prostate cancer in Kenya present at a similar mean age at diagnosis, but with more advanced disease and more aggressive tumours compared(Dickstein et al, 2009; Jonnson et al; Hemed et al, 2014).
RATIONALE FOR SCREENING
• There is no role for MASS screening for prostate cancer
• Screening for prostate cancer is a highly individualized decision between a client and his caregiver.
Text Box 1
Effects of Prostate Specific Antigen (PSA) screening
PSA screening has induced a significant downward migration in age and stage
(both cliniacal and pathologic) at diagnosis. It may also have a beneficial effect
on prostate cancer mortality. However, the absolute effect is small relative to
the number needed to screen and treat to cure a single individual. For every
1,000 men tested, approximately 100 to 120 will have an elevated PSA value
(Eastham et al, 2003).
Therefore, mass screening is not recommended.
These guidelines are meant to equip healthcare providers with information on early detection of prostate cancer for the purpose of reducing prostate cancer mortality. They should have a high index of suspicion and should be keen to screen patients presenting with the following lower urinary tract symptoms for prostate cancer:
o Frequency and nocturia
o Difficulty in starting or stopping the urine flow
o Inability to urinate
o Weak, decreased or interrupted urine stream
o A sense of incompletely emptying the bladder.
o Burning or pain during urination (dysuria)
o Post-micturition dribbling
o Urgency in urinating
o Blood in the urine or semen
PSA-Based Screening Guidelines
Various international organizations (listed in the references section) have issued guide-
lines on prostate cancer screening. These guidelines differ in their recommendations
|•||Whether or not to provide routine PSA-based prostate cancer screening|
|•||In what age groups and life expectancies|
However, the guidelines agree that:
|•||PSA-based prostate cancer screening requires an informed, shared|
|•||The decision should reflect the patient’s understanding of the possible|
|benefits and risks|
|•||The decision should respect the patient’s preferences and values.|
SHARED DECISION MAKING
A well-informed patient understands the ratio of benefit to harm of prostate cancer screening
Text Box 2
PSA-based screening should not be performed in the absence of shared-decision making between clinicians and clients. This effectively discourages organized mass screening in settings where shared-decision making is not part of routine practice (e.g. in health camps, health system promotions, community organizations and religious or political meetings).
What a man needs to know before making a decision about PSA screening:
• There is no perfect screening test
• Screening may have associated harms
• Prostate biopsy & treatment of prostate cancer have
Text Box 3
Men considering a screening test for prostate cancer should be aware of several facts:
1. Prostate gland anatomy and function
2. The ratio of benefit to harm of screening:
Evidence shows that the absolute benefits of prostate cancer screening are modest for men age SS to 69 years, while the harms are substantial (Eastham et al, 2003).
a) Putative (evident) mortality benefit of screening
The lifetime risk of prostate cancer is 1 in 6 men. Diagnosis is made in 1 in 9 men and out of these, only 3% of these will die of prostate cancer. (ACS, 2018). Men should consider the threat posed by prostate
cancer and weigh this against other potential life-threatening conditions that they may have. The ratio of benefit to harm can be improved by considering the age and health status of the individual (Welch et al, 2009), and a man’s personal preferences.
b) Harms of screening
PSA screening can lead to psychological harm and biopsy related com-
plications. The greatest harm associated with prostate cancer
screening is the detection of cancers that would otherwise have
remained undetected without screening (over-diagnosis), subsequent
treatment of these cancers (over treatment) and the
associated side effects from a treatment that does not improve survival.
In addition, prostate biopsies and treatments targeting localized
prostate cancer have adverse effects, including pain, fever, bleeding,
infection or problems urinating, with possible need for hospitalization
(Carlsson et al, 200S and Loeb et al, 2012).
3. The likelihood of false-positive and false-negative results
• No screening test is perfect. DRE is not very sensitive and will miss
many early prostate cancers. PSA test can generate a
significant number of false positive results due to low specificity. A
high PSA often leads to a biopsy being performed with many ending
up negative, exposing the patient to the side effects of biopsy
• PSA cut-off determines the rate of false positives. Cut-off points of
<4.0 ng/mL can lead to higher rates of false positives (Volk et al, 2007;
Schroder et al, 2009).
4. Description of options & follow-up tests after abnormal PSA is detected. These are articulated below under the discussion on biopsy trigger
5. Treatment options & outcomes for early and late prostate cancer and their possible complications: Possible treatment outcomes in men diagnosed with prostate cancer include:
• Recurrent cancer that will progress despite their treatment
• No evidence of disease recurrence, but no benefit from treatment
either because their cancer was never destined to progress
• No evidence of disease recurrence because their cancer was cured.
Complications of biopsy and treatment in patients screened include, but are not limited to the following: Serious cardiovascular events, deep venous thrombosis or pulmonary embolus, erectile dysfunction, incontinence, and even death (Eastham et al, 2003).
WHO SHOULD BE SCREENED
Men to be screened include:
• ≥40 years, of African descent
• 55-69 years, of Caucasian or Asian origin
• 40-55 years, with a family history of prostate cancer
Text Box 4
Decisions regarding prostate cancer screening should be individualized, based on per- sonal preferences and an informed decision regarding the uncertainty of benefit and the associated harms of screening. The likelihood of prostate cancer in an individual with a family history of the disease increases directly with the number of affected first degree relatives, and is higher if the disease occurred in multiple generations and/or was diagnosed at an early age (below age SS years) as compared to a diagnosis in a sin- gle generation at an older age (Mohan et al, 2011).
These guidelines DO NOT recommend routine screening for the following groups:
• Men aged ≤40 years – due to the low prevalence of disease in this age
• Men aged 40 – 54 years at average risk – Caucasians and Asians
• Men age 70 years and above -Though they have a high prevalence
of prostate cancer, they also have a greater risk of life-threatening
co-morbidities and over-diagnosis compared to younger men.
• Any man with a life expectancy less than 10-15 years
FREQUENCY OF SCREENING BY AGE
|Symptoms & Age||PSA level||Frequency of testing|
|• Asymptomatic & 55-69 years
• 40-54 years with a family history of prostate cancer
• Age ≥ 40 years with a family history of
|A 1 ng/ml||Every two years*|
|1- 4ng/ml||Every year|
|>60 years||2ng/ml||Every 2 years|
Source: Mottet et al, 2017 and Conford et al, 2017
*Evidence suggests that annual screening is not likely to produce significant incremental benefits when compared with a two-year screening interval (Kerkhof et al, 2010).
• PSA > 10ng/ml – generally should lead to a biopsy.
• PSA 4 – 10ng/ml – require further interrogation with adjunctive studies like
multi-parametric MRI of the prostate. In addition, DRE, PSA derivatives (PSA density and
age specific reference ranges) and PSA kinetics (velocity and doubling time), PSA molec-
ular forms (percent free PSA and proPSA), newer urinary markers (PCA3), and prostate
imaging should be considered secondary tests (not primary screening tests) that can
help to guide on the justification for a prostate biopsy.
Interpretation of PSA results
• There is no PSA level below which a man can be informed that he does not have prostate cancer. Rather, the risk of prostate cancer, and that of high-grade disease, is continuous as PSA increases (Carter et al, 1997). The urologist should consider factors that lead to an increased PSA including prostate volume, patient’s age, inflammation, ratio of total to free PSA, PSA velocity and PSA doubling time, rather than using an absolute level to determine the need for a prostate biopsy.
• The use of antibiotics to reduce PSA levels in otherwise asymptomatic men is
strongly discouraged, and this practice could lead to an increased
risk of post-biopsy sepsis. A patient with urinary symptoms should be treated
for the infection and the PSA re-confirmed.
• Use of Finasteride or 5 alpha reductase inhibitors can reduce the PSA level by
50%, the PSA result needs to be interpreted using the PSA ratio.
• Ideally the PSA should be done in the same laboratory to avoid inter-
Age-Specific Reference Range For Serum PSA
|Age Range in
|40 – 49||0 – 2.0 ng/ml||0 – 2.0 ng/ml||0 – 2.5 ng/ml|
|50 – 59||0 – 4.0 ng/ml||0 – 3.0 ng/ml||0 – 3.5 ng/ml|
|60 – 69||0 – 4.5 ng/ml||0 – 4.0 ng/ml||0 – 4.5 ng/ml|
|70 – 79||0 – 5.5 ng/ml||0 – 5.0 ng/ml||0 – 6.5 ng/ml|
No local data hence this is adopted from international data: (Oesterling et al, 1993 and
Dalkin et al, 1993)
WHO SHOULD DO THE SCREENING?
A general practitioner can prescribe a PSA test in a well-informed patient.
Patients with a PSA >4ng/ml regardless of other parameters, should be referred to a
urologist for further management. The final diagnosis of prostate cancer must be
histological after a biopsy is done.
The standard method of early detection for prostate cancer relies on these 3 tests:
1. Serum PSA test
2. Digital rectal examination (DRE)
3. Transrectal ultrasonography (TRUS) guided biopsy
Text Box 5
SCREENING AT VARIOUS HEALTHCARE LEVELS
A PSA test should be available from Level 4 hospitals and above, and at accredited
Follow up of PSA testing should ideally be in the same laboratory. A high PSA should be
re-confirmed in the same laboratory.
Most prostate cancers are located in the peripheral zone of the prostate. DRE may not pick small, central or anteriorly-located cancers. DREs are also subjective. Performing a DRE does not significantly increase PSA levels.
Definitive diagnosis of prostate cancer depends on the histopathologic verification of adenocarcinoma in prostate biopsy cores or operative specimens. Transrectal ap- proach is used for most prostate biopsies but a trans-perineal approach can be used for patients without a rectum (due to a previous resection of the rectum). The minimum number of core samples required to make a proper diagnosis is 10 (Extended prostate biopsy protocol).
Algorithm for Prostate Cancer Screening and
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Organizations that have issued guidelines on prostate cancer screening:
• American Cancer Society (ACS)
• American Urological Association (AUA)
European Association of Urology/European Society for
Radiotherapy and Oncology/International Society of Geriatric
• European Society for Medical Oncology (ESMO)
• National Comprehensive Cancer Network (NCCN)
• U.S. Preventive Services Task Force (USPSTF)