Prostate Cancer Awareness and Quality Improvement

ProgrammeUpdate

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-management-and-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 life-threatening 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. Improving access2. Supporting management in PHC 3. Removing barriers4. 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 RiskBenefits 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 treatmentRisk of curative treatment

PSA • PSA is organ-specific rather than cancer-

specific• 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 Abnormal PSA level (μg/L)

≤ 70 years ≥ 4.0 71–75 years ≥ 10.0 ≥ 76 years ≥ 20.0

• If PSA 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-using-active-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