Prostate cancer clinical quality performance indicators: engagement document

Procedure for performing prostate biopsy should be optimised.

Proportion of patients with prostate cancer who undergo
trans-rectal ultrasound guided ( TRUS) prostate biopsy for histological diagnosis where a minimum of 10 cores are received by pathology.

Where biopsy is being undertaken to diagnose prostate cancer a minimum of ten cores of tissue should be taken to ensure adequate sampling ^[3,4,5]

In line with recommended best practice local anaesthetic should be given to patients undergoing TRUS prostate biopsy ^[6] .

Numerator:

Number of patients with prostate cancer who undergo TRUS biopsy where a minimum of 10 cores are received by pathology.

Denominator:

All patients with prostate cancer who undergo TRUS biopsy of the prostate.

Exclusions:

• Patients enrolled in clinical trials
• Patients with advanced (T4NanyMany) or metastatic disease (TanyNanyM1)

90%

The tolerance within this target is designed to account for situations where, due to clinical suspicion, a smaller number of cores will suffice if the biopsy operator is satisfied they have taken sufficient tissue to make a histological diagnosis.

In addition, some patients may become unwell during the procedure, meaning that the procedure may have to be abandoned.

Patients with intermediate or high risk prostate cancer, who are suitable for radical treatment, should be evaluated for locally advanced, nodal or bony metastatic disease.

Proportion of patients with intermediate or high risk prostate cancer undergoing radical treatment who have had Magnetic Resonance Imaging ( MRI) and bone scan staging.*

Please note that this QPI measures two distinct elements:

(i) Patients with intermediate prostate cancer who undergo MRI.

(ii) Patients with high risk prostate cancer who undergo MRI and bone scan.

Local staging is of importance in helping guide both patient and clinician towards a treatment decision. Whilst digital rectal examination, Prostate Specific Androgen ( PSA) level and needle biopsy histology together help predict the likelihood of organ-confined disease, this is on a population rather than individual patient basis. In addition, needle biopsies are prone to sampling error. Therefore the management of a patient predicted to have organ confined disease by the above parameters who unexpectedly on MRI has definite capsular, seminal vesicle, nodal or bony involvement (or a predominant anterior tumour not palpable or reached by biopsy) may be radically changed by that MRI result. Similarly, patients predicted to have significant risk of locally advanced disease may be considered suitable for radical treatment if the MRI shows organ-confined disease. Clearly patients found to have bone metastases are by definition not suitable for radical treatment ^[7,8,9] .

Patients with high-risk prostate cancer should have MRI to assess the extent of disease ahead of radical treatment ^[4] .

* For patients with intermediate risk prostate cancer with PSA <10 at diagnosis a bone scan is not routinely recommended ^[4] .

Numerator:

Number of patients with intermediate risk prostate cancer undergoing radical treatment who have an MRI of the prostate.

Denominator:

All patients with intermediate risk prostate cancer undergoing radical treatment.

Exclusions:

• Patients unable to undergo an MRI scan:
  • Pacemaker or other MRI incompatible implanted device.
  • Cerebral aneurysm clip.
  • Metal in eye.
  • Claustrophobia.
  • Unable to fit bore of scanner.
  • Too heavy for MRI table.
• Patients who refuse MRI.

95%

The tolerance within this target is to account for situations where patients are deemed clinically unsuitable or unfit to undergo MRI.

Numerator:

Number of patients with high risk prostate cancer undergoing radical treatment who have an MRI of the prostate and isotope bone scan (or alternative whole body MRI evaluation).

Denominator:

All patients with high risk prostate cancer undergoing radical treatment.

Exclusions:

• Patients unable to undergo an MRI scan:
  • Pacemaker or other MRI incompatible implanted device.
  • Cerebral aneurysm clip.
  • Metal in eye.
  • Claustrophobia.
  • Unable to fit bore of scanner.
  • Too heavy for MRI table.
• Patients who refuse MRI.

95%

The tolerance within this target is to account for situations where patients are deemed clinically unsuitable or unfit to undergo MRI.

All surgical pathology reports for prostate needle biopsies should contain full pathology information to inform treatment decision making.

Proportion of patients who undergo needle biopsy where the pathology report contains a full set of data items (defined by the Scottish Urological Pathologists dataset - see appendix 4).

To help plan treatment for men diagnosed with prostate cancer, prognostic information from the needle biopsy is necessary. The use of datasets improves the completeness of data in pathology reports and a minimum prostate cancer dataset has been agreed for Scotland based on the Royal College of Pathologists most recent Standard and Guideline for Prostate Cancer ^[10,11] .

Numerator:

Number of patients with prostate adenocarcinoma who undergo prostate needle biopsy where needle biopsy pathology report contains all data items (as defined in the Scottish Urological Pathologists dataset - see appendix 4).

Denominator:

All patients with prostate adenocarcinoma who undergo prostate needle biopsy.

Exclusions:

• No exclusions.

90%

The tolerance within this target is designed to account for situations where it is not possible to report all components of the dataset due to specimen size.

Patients should be discussed by a multidisciplinary team prior to definitive treatment.

Proportion of patients with prostate cancer who are discussed at MDT meeting before definitive treatment.

Evidence suggests that patients with cancer managed by a multi-disciplinary team have a better outcome. There is also evidence that the multidisciplinary management of patients increases their overall satisfaction with their care ^[12] .

Discussion prior to definitive treatment decisions being made provides reassurance that patients are being managed appropriately.

Numerator:

Number of patients with prostate cancer discussed at the MDT before definitive treatment.

Denominator:

All patients with prostate cancer.

Exclusions:

• Patients who died before first treatment.

95%

The tolerance within this target accounts for situations where patients require treatment urgently.

Men under active surveillance for prostate cancer should undergo appropriate investigations at the clinically relevant timings.

Proportion of men under active surveillance for prostate cancer who undergo multiparametric MRI within 6 months, and prostate re-biopsy within 14 months of diagnosis

Please Note: the specifications of this QPI are separated to ensure clear measurement of patients who have undergone:

(i) Multiparametric MRI within 6 months of diagnosis

(ii) Prostate re-biopsy within 14 months of diagnosis

Different treatment options are available for men with low risk prostate cancer including surgery, radiotherapy and also active surveillance. Active surveillance as a treatment option can reduce overtreatment and therefore reduce potential adverse effects from radical treatments as well as being beneficial in terms of healthcare costs. ^{[13, 14]}

It is recommended that men who are undergoing active surveillance should have a multiparametric MRI performed at enrolment of active surveillance if not previously performed. A prostate re-biopsy should also be performed at the Year 1 end of active surveillance. ^[15]

Numerator:

Number of patients undergoing multiparametric MRI within 6 months of diagnosis

Denominator:

All patients under active surveillance

Exclusions:

• Patients unable to undergo an MRI scan:
  • Pacemaker or other MRI incompatible implanted device.
  • Cerebral aneurysm clip.
  • Metal in eye.
  • Claustrophobia.
  • Unable to fit bore of scanner.
  • Too heavy for MRI table.
• Patients who refuse MRI.

75%

The tolerance within this target is to account for situations where patients are deemed clinically unsuitable or unfit to undergo MRI.

Please note: In order to ensure that the chosen target level is the most appropriate and drives continuous quality improvement as intended it will be kept under review and revised as necessary, once baseline data or further evidence becomes available.

Numerator:

Number of patients undergoing trans-rectal ultrasound guided ( TRUS) prostate re-biopsy

within 14 months of diagnosis

Denominator:

All patients under active surveillance

Exclusions:

• Patients who undergo radical treatment within 14 months of diagnosis

75%

The tolerance within this target is to account for situations where patients are deemed clinically unsuitable to undergo re-biopsy as well as factors relating to patient choice.

Please note: In order to ensure that the chosen target level is the most appropriate and drives continuous quality improvement as intended it will be kept under review and revised as necessary, once baseline data or further evidence becomes available.

Organ confined prostate cancers which are surgically treated with radical prostatectomy should be completely excised.

Proportion of patients with pathologically confirmed, organ confined (stage pT2) prostate cancer who undergo radical prostatectomy in which tumour is present at the margin, i.e. positive surgical margin.

Positive surgical margin is an independent prognostic factor in adversely impacting biochemical recurrence free ( PSA failure) period and progression free survival ^[6] .

Numerator:

Number of patients with stage pT2 prostate cancer who underwent radical prostatectomy in which tumour is present at the margin.

Denominator:

All patients with stage pT2 prostate cancer who underwent radical prostatectomy.

Exclusions:

• None

<20%

Please Note: Varying evidence exists regarding the most appropriate target level therefore this may need redefined in the future, to take account of new evidence.

Surgery should be performed by surgeons who perform the procedure routinely.

Number of radical prostatectomy procedures performed by a surgeon over a 1 year period.

Radical prostatectomy should be performed by surgeons who work in high-volume hospitals, with outcomes audited regularly ^[3,6] .

The European and North American literature supports the view that there is a relationship between increasing surgeon volume and improved patient outcomes, for example, rates of post-operative and late urinary complications and positive surgical margin rates ^[6] .

Studies have shown that there is a clear link between surgeon experience and improved clinical outcomes and this continues to increase with the number of cases undertaken. ^{[16, 17, 18]}

For robotic assisted radical prostatectomy it has been suggested that individual surgeons should undertake a minimum of 50-100 cases per annum. ^[19]

Number of radical prostatectomies performed by each surgeon in a given year.

Exclusions:

• None

Minimum 50 procedures per surgeon in a 1 year period.

This is a minimum target level and is designed to ensure that all surgeons performing radical prostatectomy perform a minimum of 50 procedures per year.

Please Note: It is recommended that where two consultants operate together on the same patient the case should be counted under the Lead Surgeon.

Patients with metastatic prostate cancer should undergo immediate hormone therapy ^[c] , and chemotherapy where appropriate ^[d] .

Proportion of patients with metastatic prostate cancer (TanyNanyM1) who undergo immediate management with hormone therapy, and docetaxel chemotherapy.

Please note:

The specifications of this QPI are separated to ensure clear measurement of both patients who receive:

(i) Immediate hormone therapy; and

(ii) Immediate hormone therapy and docetaxel chemotherapy

There is evidence for symptom palliation and possible survival benefit in symptomatic metastatic patients, and for prolonged progression-free survival in asymptomatic patients with metastatic prostate cancer ^[4,6] .

LHRH agonist / antagonist monotherapy or Duel Androgen Blockade ( LHRH agonist plus anti-androgen combined therapy) or bilateral orchidectomy should be offered as immediate therapy to all patients with metastatic prostate cancer ^[3,6,20] .

Docetaxel chemotherapy has shown evidence of improved survival when given in conjunction with hormone therapy and should be offered to men who are suitably fit as part of their care ^[21] .

The hormone therapy should be licensed in this indication as monotherapy or in combination with an anti-androgen for dual androgen blockade. Bilateral orchidectomy is an acceptable form of hormone therapy in this context.

Numerator:

Number of patients presenting with metastatic prostate cancer (TanyNanyM1) treated with immediate hormone therapy

Denominator:

All patients presenting with metastatic prostate cancer (TanyNanyM1).

Exclusions:

• Patients documented to have refused immediate hormone therapy.
• Patients enrolled in clinical trials.

95%

The tolerance within this target is to account for the fact that due to co-morbidities and fitness not all patients will be suitable for treatment.

Numerator:

Number of patients presenting with metastatic prostate cancer (TanyNanyM1) treated with immediate hormone therapy ( LHRH agonist/ antagonist monotherapy, duel androgen blockade or bilateral orchidectomy) and docetaxel chemotherapy.

Denominator:

All patients presenting with metastatic prostate cancer (TanyNanyM1).

Exclusions:

• Patients documented to have refused immediate hormone therapy.
• Patients documented to have refused chemotherapy
• Patients with performance status 2 or worse
• Patients enrolled in clinical trials.

70%

The tolerance within this target is to account for the fact that due to co-morbidities and fitness not all patients will be suitable for treatment.

Please note: In order to ensure that the chosen target level is the most appropriate and drives continuous quality improvement as intended it will be kept under review and revised as necessary, once baseline data or further evidence becomes available.

Post surgical incontinence for patients with prostate cancer should be minimised.

Proportion of prostate cancer patients who undergo radical prostatectomy with post surgical incontinence approximately 1 year (between 10 and 14 months) after surgery.

Urinary incontinence, especially over the long-term, is significant and is associated with poor quality of life, this therefore requires to be minimised in men undergoing surgery for prostate cancer ^[4,6] .

Numerator:

Number of patients with prostate cancer undergoing radical prostatectomy with post surgical incontinence (>0 pads per day measured using a validated tool ^[e] ) at 1 year (10-14 months) post radical prostatectomy.

Denominator:

All patients with prostate cancer undergoing radical prostatectomy.

Exclusions:

• Patients who undergo salvage prostatectomy.
• Patients who receive adjuvant radiotherapy within 6 months of surgery.

<20%

Numerator:

Number of patients with prostate cancer undergoing radical prostatectomy with post surgical incontinence (greater than 1 pad per day measured using a validated tool) at 1 year
(10-14 months) post radical prostatectomy.

Denominator:

All patients with prostate cancer undergoing radical prostatectomy.

Exclusions:

• Patients who undergo salvage prostatectomy.
• Patients who receive adjuvant radiotherapy within 6 months of surgery.

<10%

30 day mortality following systemic anti-cancer treatment for prostate cancer.

Proportion of patients with prostate cancer who die within
30 days of systemic anti-cancer treatment.

Outcomes of treatment, including treatment related morbidity and mortality should be regularly assessed. ^[22]

Treatment should only be undertaken in individuals that may benefit from that treatment, that is, treatments should not be undertaken in futile situations. This QPI is intended to ensure treatment is given appropriately, and the outcome reported on and reviewed.

Numerator:

Number of patients with prostate cancer who receive systemic anti-cancer treatment that die within 30 days of treatment.

Denominator:

All patients with prostate cancer who receive systemic anti-cancer treatment.

Exclusions:

• No exclusions

<5%