Download Guidance on Using Active Surveillance to Manage Men

Prostate Cancer Awareness and
Quality Improvement
Programme
Update
Trish White
Nurse Practitioner: Adult Urology
October 2015
Prostate Cancer Management
and Referral Criteria
Published MOH September 2015
http://www.health.govt.nz/publication/prostate-cancer-managementand-referral-guidance
Introduction
NZ men currently receive conflicting advice
With routine prostate specific
antigen (PSA) testing, many men
can be diagnosed with a cancer
that is not going to progress
during their lifetime. It may
increase exposure to unnecessary
treatment-related harms.
BUT some men will still develop
aggressive and potentially lifethreatening prostate cancer.
These men may benefit from
prompt diagnosis and treatment.
Development process
This guidance was developed by the Primary Care
Sub-group of the Prostate Cancer Working and aims to
improve prostate cancer care for New Zealand men by:
1.
2.
3.
4.
Improving access
Supporting management in PHC
Removing barriers
Consistent care and equitable outcomes
DHB’s and PHOs are responsible for integrating this
guidance into their clinical pathways for prostate
cancer
Preliminary Considerations
Age
– No clear evidence on when to start
– 50 - 70yrs, or 40 if family history
– >70, normal DRE, previous normal PSA no need to
test further EXCEPT if raised PSA, family hx and
otherwise well with life expectancy >10yrs
Family History
– Father or brother, twice as likely
– Two or more <65, 5 – 11x more likely
– Approx 9% will have the true hereditary form of
the disease
Preliminary Considerations
Ethnicity
– In 2011, Māori men were about 18% less likely to be
diagnosed with prostate cancer, but were 37% more
likely to die (MOH, 2014).
– Reasons unclear: access
Other demographic and lifestyle factors
– Rural or low-decile communities may have restricted
access, higher proportion of men being tested in
decile 1 communities compared with decile 10 (Gray
et al 2005).
– Conflicting evidence whether obesity, smoking, diet,
prostatitis or sexually transmitted infections can
increase risk
Informed Consent
• Verbal prior PSA test and/or DRE.
• Must understand benefits and risks before he
makes his decision
• Including what could happen if results positive
Benefits and Risk
Benefits of prostate cancer testing
• Unlikely if PSA and DRE are normal.
• If positive it is more likely to be early stage, meaning that the chance of
cure is greater (Albertson et al 2005; Cooperberg et al 2010).
• If localised, low-risk prostate cancer found he has the option of AS
Risks of prostate cancer testing
• Potential for false positives due to calcifications in the prostate, prostatitis,
urinary tract infection, benign prostatic hypertrophy, recent ejaculation or
cycling.
• False negatives when the prostate cancer releases no or little PSA.
Prostate Biopsy
Active Surveillance
Benefit of curative treatment
Risk of curative treatment
PSA
• PSA is organ-specific rather than cancerspecific
• Other factors can cause temporary increase
– No PSA within 2/7 DRE or 3/7 ejaculation or
cycling
• Higher the PSA the more likely they have
cancer
• Increased PSA levels can be transient, repeat
6-12/52
– Exceptions if also abnormal DRE or red flag*
DRE
• Most located in the peripheral zone and some can
be detected on DRE as a hard, discrete nodule or
with asymmetry
• An enlarged prostate gland is not a good indicator if
PSA normal
• If abnormal refer to urology service
• Reluctance: Māori and Pasifika cultural barrier
inform 20% diagnosed from an abnormal DRE when
PSA normal
• If declines, acceptable to refer based on two clearly
abnormal PSA results.
Algorithm
Man presents
with prostate
related concerns
Abnormal PSA
Age group
≤ 70 years
71–75 years
≥ 76 years
• If PSA
Abnormal PSA level (μg/L)
≥ 4.0
≥ 10.0
≥ 20.0
4 – 10 40% chance of cancer on biopsy
10 – 20 68%
>20
highly likely with mets
Pathway following referral to Urology
Services
Red Flags
Acute neurological symptoms consistent with spinal cord or cauda equina compression
• Spinal cord compressions 12% with metastatic disease
• Frequently presents as increasingly severe back pain and subsequent neurological symptoms
including weakness, unsteadiness, numbness, urinary retention, urinary incontinence or
faecal incontinence.
• Immediate referral to radiation oncology service where available otherwise urology
Renal failure
• Can be present in locally advanced disease on DRE. Symptoms of renal failure include
tiredness, lack of energy, nausea, peripheral oedema and poor appetite.
Bone pain
• Indicator Metastatic prostate cancer
• May present as new-onset, progressive and severe bone pain, often with local tenderness.
• Men with a clearly abnormal PSA and bone pain should be discussed with a urologist –TRUS,
ADT
• If the bone pain is severe, admission to hospital should also be considered for symptom
control.
Macroscopic haematuria (without urinary tract infection)
• Rare late sign
• Discuss with Urologist
Urgency of referrals to urology or
radiation oncology
Type of
referral
Criteria
Immediate
referral
(within 24
hours)

PSA is ≥ 10 µg/L AND severe back pain AND acute neurological
symptoms are present consistent with spinal cord compression or
cauda equine compression (Note: where available, refer to a radiation
oncology service in the first instance by phone consult with on-call
radiation oncologist)
Urgent
referral
(within 14
days)

PSA is ≥ 10 µg/L AND renal failure is present (Note: phone consult
with an on-call urologist is recommended)
PSA is ≥ 10 µg/L AND bone pain is present (new onset progressive
and severe) is present (Note: phone consult with an on-call urologist
or radiation oncologist is recommended)
PSA is ≥ 10 µg/L AND macroscopic haematuria is present (Note:
phone consult with on call urologist is recommended)
PSA is ≥ 10 µg/L AND prostate feels hard and/or irregular on DRE



Routine
referral
(within 6–8
weeks)



PSA is between 4 and 10 µg/L AND macroscopic haematuria is
present in the absence of infection
PSA is < 10 µg/L AND prostate feels hard and/or irregular on DRE
Two clearly abnormal PSA results 6 to 12 weeks apart (see Table 1
on page 8 for definitions of a clearly abnormal PSA)
Faster Cancer Treatment Programme
• Reduce waiting times for appointments, tests
and treatment and standardise care pathways
• More likely to ensure better outcomes for
cancer patients
• Immediate or urgent referrals to a urology or
radiation oncology service should be included
in the FCT 62 day health target.
Follow-up after normal PSA and DRE
Family history
• No clear evidence
• Best practice PSA and DRE every 12 months from the
age of 40–70 years.
No family history
• No clear evidence
• >70 years, reassure not likely to be of benefit
• If requested offer PSA tests and DREs every two to four
years (Catalona et al 2011; Basch et al 2012)
Guidance on Using Active
Surveillance to Manage Men
with Low-risk Prostate Cancer
Published July 2015 MOH
http://www.health.govt.nz/publication/guidance-usingactive-surveillance-manage-men-low-risk-prostate-cancer
What is it?
• AS was introduced because the disparity between the incidence (12%)
and death rate (3%) – NZ figures
• A management option for men with localised, low-risk prostate cancer, it
aims to avoid or delay the need for curative treatment, thereby reducing
the potential for treatment-related harms
– ≤ 3 cores involved, ≤ 50 percent of one core involved and ≤ 4 mm length
positive histology in one core.
• AS involves actively monitoring with regular PSA, DRE, biopsies and MRIs.
If progression is confirmed, the man then has the option to undergo
curative treatment
• Survival rates for men on active surveillance are approximately 80%, which
is similar to the survival rate for men with low-risk prostate cancer who
undergo curative treatment
• Only 20–30% of men with localised, low-risk prostate cancer will choose
AS. Why? – too stressful
Difference between WW & AS
Active Surveillance
Watchful Waiting
Treatment Intent
Curative
Palliative
Follow-up
Predicted schedule
Patient specific
Assessment/Makers used
PSA, DRE, repeat biopsy and
optional MRI
PSA and DRE
Life Expectancy
>10 years
<10 years
Aim
Minimise treatment-related
harms without
compromising survival
Minimise treatment related
harms
Comment
Only for men with localised
low-risk prostate cancer
Can apply to men at any
stage
Informed Consent
• Must obtain informed consent before entering
a man into AS. The decision to pursue AS is
entirely the man’s, after they consider the
benefits and risks of the different tests
involved and the other treatment options
available, offer radiation oncologist referral
• Consider health literacy
Nursing input?
No information on how many nurses involved
• NZUNS study
– Identify current practice of nurses involved in AS
– Develop recommendations
• Method
– Questionnaire sent to 20 DHBs
– NZUNS committee surveyed
Results
• 70% response rate DHB, 100% Committee
• No guidelines – 2 were under development
• 25% DHBs have nurses in this role (2 NP, 2 CNS, 1
unknown), 2 had PG training, 3 performing DRE
• Which level nurse? 77% CNS or higher
• Should AS patients be seen by nurses in PHC or
secondary services? 60% DHB only, 40% PHC
• 100% of committee and 83% DHB – standardised
national programme needed, could be delivered
regionally, support to include in PG qualification
Recommendations
• AS to be incorporated into roles of CNS, NP after initial
diagnosis and development of treatment plan by
urologist
• Collaborative team approach recommended
• If nurses involved in PHC, should also be advanced
practice urological nurses
• National training programme to ensure high quality
care
• NZUNS to be involved in development
• Standards of practice
• Quality initiatives to include Peer review, development
of lead nursing role to provide training and support,
regional liaison meetings and benchmarking
Benefits
• Advanced practice nurses providing care will
allow sufficient time for ongoing education of
men
• Allow urologist to focus on higher acuity
patients
• Benefit elective service waiting times
• Contribute to meeting FCT programme
• Improve job satisfaction of urology nurses
Active Surveillance Pathway
Requirements
• Year 1
– Measure PSA every 3 months
– DRE every 6 months
– Prostate biopsy at 12 months
• Years 2 and every subsequent year
– Measure PSA every 3–12 months +/- DRE
– Prostate biopsy every 2–4 years
Multi-parametric MRI should be considered prior to
entry to active surveillance and before repeat
prostate biopsy
Overall Responsibility
• Urologist
– make key decisions about biopsy and MRI
• Shared care with other health professionals including
nurses. This should be discussed with the man and
agreed on a case-by-case basis
• Responsibilities of the urologist and the other health
professional to be clearly documented in the man’s AS
care plan
• Urologists should review AS care plans at least every 12
months
Exit Criteria
If a man meets any of the following criteria for exiting active surveillance, his
treatment should be changed to curative treatment or watchful waiting:
•
•
•
•
•
life expectancy < 10 years
repeat biopsy shows Gleason score > 3 + 3 = 6 (ISUP grades 2, 3, 4 or 5)
higher-volume prostate cancer
PSA ≥ 10 µg/L
tumour stage is > T1 or low-volume T2 (T2a).
It is anticipated that 30% of men undergoing AS will exit their care plan and
undergo curative treatment.
A man can decide to exit active surveillance at any time, having decided it is
no longer his preferred option. This typically occurs within the first two
years
New grading system on the way
• International Society of Urological Pathology
(ISUP) Dr Brett Delahunt
• ISUP 1 – 5
• 1 = Gleason 6
• 2 = 3+4
• 3 = 4+3
• 4=8
• 5 = 9/10
• Reporting both
Next on the agenda!
• Develop and implement guidance for managing
advanced and metastatic prostate cancer
• Develop and implement guidance for the
treatment of prostate cancer
• Develop national tumour standards and key
indicators for prostate cancer
– Develop standards and indicators for staging
investigations of prostate cancer
– Improve access to multi-disciplinary meetings
– Implement the monitoring and evaluation of prostate
cancer diagnosis and treatment times