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RCPA Cancer Protocols IG (v0.1.0: Release 1 Draft). This is the current published version based on FHIR R3. See the Directory of published versions

Logical Model Mappings FHIR Resources HL7 V2.4 Messaging

Prostate Report

This implementation guide is developed from the Royal College of Pathologists of Australasia's (RCPA) "Prostate Cancer (Radical Prostatectomy) - Structured Reporting Protocol" (2nd edition 2014). There are separate protocols for core (needle) biopsies and transurethral resection (TUR) specimens.

Structured reporting aims to improve the completeness and usability of pathology reports for clinicians, and improve decision support for cancer treatment. The protocol provides the framework for the reporting of any prostate (radical prostectomy) cancer, whether as a minimum data set or fully comprehensive report. The prostate (radical prostectomy) cancer protocol is based on information contained within multiple international publications and datasets and has been developed in consultation with local practising pathologists, oncologists, surgeons, radiologists and interested national bodies.

This implementation guide is developed as part of RCPA's PITUS 15-16 working group 5 project - Report Modelling.

This is the Prostate Logical Model. For context, see the explanation of how this guide works.

Prostate Report

NameFlagsCard.TypeDescription & Constraintsdoco
.. Prostate
... subject Σ1..1Reference(Patient), Reference(Group)
... requester Σ0..1Reference(Practitioner)
... performer Σ0..1Reference(Practitioner), Reference(Organization)
... preAnalytic 0..1
.... clinicalInformation 0..1string
.... natureOfSpecimen 0..1string
.... clinicalHistory 0..*string
.... previousTherapy 0..1string
.... psa 0..*Quantity
.... stagingInfo 0..1string
.... pathologyAccessionNumber 0..1string
.... principalClinician 0..1Reference(Practitioner)
.... comments 0..1string
... macro 0..1
.... specimenWeight 1..1Quantity
.... specimenDimension1 0..1Quantity
.... specimenDimension2 0..1Quantity
.... specimenDimension3 0..1Quantity
.... seminalVesicles 0..1codeBinding: ProstateRadSeminalVesiclesMacro (required)
.... lymphNodes I0..101: If lymph nodes are present consider recording G2.20 (laterality & site(s) and numbers of lymph nodes)
09: If lymph nodes are present record S3.07 lymph node status.
..... code 0..1codeBinding: PresentAbsentNa (required)
..... laterality 0..1codeBinding: Laterality (required)
..... site 0..*string
..... numLymphNodes 0..*integer
..... numLymphNodesPositive 0..*integer
.... blockIdentificationKey 0..*string
.... otherMacroComments 0..1string
... micro 0..1
.... tumourType I1..*codeBinding: ProstateRadTumourType (required)
02: If the histological tumour type is other, then record the other type.
03: If the histological tumour type is Adenocarcinoma (Acinar variant eg foamy, pseudohyperplastic), then record the variant.
.... tumourFocality 0..*string
.... tumourLocation 0..1
..... quadrant I0..1codeBinding: NoduleLocation (required)
..... plane 0..1codeBinding: ProstateRadNodulePlane (required)
..... otherNodule I0..*04: If there are other nodules >10mm in diameter then record the locations in quadrant and plane.
...... code 0..1codeBinding: PresentAbsent (required)
...... quadrant 0..*codeBinding: NoduleLocation (required)
...... plane 0..*codeBinding: ProstateRadNodulePlane (required)
.... intraglandularExtent 0..1Quantity
.... sizeDominantNodule 0..1Quantity
.... histologicalGrade 0..1
..... primary 1..1codeBinding: GleesonGradePrimary (required)
..... secondary 0..1QuantityBinding: GleesonGradeSecondary (required)
..... tertiary 0..1QuantityBinding: GleesonGradeTertiary (required)
..... score 0..1string
.... extraprostaticExtension I0..105: If an extraprostatic extension is present, then record the extent and consider recording the locations(s) of the EPE.
..... code I1..1codeBinding: ExtraprostaticExtension (required)
..... extent 0..1codeBinding: FocalNonFocal (required)
..... location I0..*codeBinding: ProstateRadTumourLocations (required)
06: If the location of the extraprostatic extension is other, then record the record the other locations(s) of the EPE.
..... comment 0..1string
.... margin 0..1
..... status I1..1codeBinding: MarginStatus (required)
07: If the margin status is involved, the record the location(s) and optionally the extent; the Gleason score at the margin and the type of positivity.
..... locationCode 0..*codeBinding: ProstateRadTumourLocations (required)
..... locationDescription 0..1string
..... extent 0..1Quantity
..... score 0..1Quantity
..... positivity 0..*codeBinding: ProstateRadMarginPositivity (required)
.... seminalVesicles I1..1codeBinding: ProstateRadSeminalVesiclesMicro (required)
08: If the seminal vesicles are involved, then record the side.
.... bladderNeck 0..1codeBinding: ProstateRadBladderNeck (required)
.... lymphNodeStatus 0..1
..... number 0..1Quantity
..... numberPositive I0..1Quantity10: If there are positive lymph nodes consider recording G3.09 laterality and G3.10 maximum dimension of largest deposit.
..... laterality I0..1codeBinding: Laterality (required)
11: If there are positive lymph nodes with indicated laterality consider recording the site(s) of the involved nodes.
..... sitesInvolved 0..1string
..... maxDimension 0..1Quantity
..... invasion 0..1codeBinding: NotIdentifiedPresentIndeterminate (required)
.... addtionalComment 0..1string
... synthesisOverview 0..1
.... tumourStage 0..1string
..... stagingSystemDetails 0..1string
.... tumourStageT 0..1codeBinding: ProstateRadTuourStageT (required)
.... tumourStageN 0..1codeBinding: ProstateRadTuourStageN (required)
.... tumourStageM 0..1codeBinding: ProstateRadTuourStageM (required)
.... diagnosticSummary 0..1string
.... overarchingComment 0..1string

doco Documentation for this format

Data Element Definitions

Prostate
Definition

Prostate cancer This protocol contains standards and guidelines for the structured reporting of radical prostatectomy specimens for prostate carcinoma. There are separate protocols for core (needle) biopsies and transurethral resection (TUR) specimens.

Control0..?
Prostate.id
Definition

unique id for the element within a resource (for internal references). This may be any string value that does not contain spaces.

Control0..1
Typestring
Prostate.extension
Definition

May be used to represent additional information that is not part of the basic definition of the element. In order to make the use of extensions safe and manageable, there is a strict set of governance applied to the definition and use of extensions. Though any implementer is allowed to define an extension, there is a set of requirements that SHALL be met as part of the definition of the extension.

Control0..*
TypeExtension
Alternate Namesextensions, user content
Comments

There can be no stigma associated with the use of extensions by any application, project, or standard - regardless of the institution or jurisdiction that uses or defines the extensions. The use of extensions is what allows the FHIR specification to retain a core level of simplicity for everyone.

Prostate.subject
Definition

The subject of the report. Usually, but not always, this is a patient. However diagnostic services also perform analyses on specimens collected from a variety of other sources.

Control1..1
TypeChoice of: Reference(Patient), Reference(Group)
Alternate NamesPatient
Prostate.requester
Definition

The practitioner that holds legal responsibility for ordering the investigation.

Control0..1
TypeReference(Practitioner)
Prostate.performer
Definition

The diagnostic service that is responsible for issuing the report.

Control0..1
TypeChoice of: Reference(Practitioner), Reference(Organization)
Requirements

Need to know whom to contact if there are queries about the results. Also may need to track the source of reports for secondary data analysis.

Alternate NamesLaboratory, Service, Practitioner, Department, Company
Comments

This is not necessarily the source of the atomic data items - it is the entity that takes responsibility for the clinical report.

Prostate.preAnalytic
Definition

Pre Analytic component - information collection prior to specimen receipt at laboratory.

Control0..1
Comments

This is just a group/section header and is not a result field.

Prostate.preAnalytic.clinicalInformation
Definition

Clinical information provided on request form.

Control0..1
Typestring
Prostate.preAnalytic.natureOfSpecimen
Definition

Nature of the specimen: For prostatectomy specimens, it is important to state the nature of the surgical procedure — open prostatectomy (for benign disease), or radical prostatectomy (for cancer) and the completeness of excision of the tumour. On those occasions where the surgeon is aware that a surgical incision into the prostate has produced an artificial margin inside the true resection margin, this should be specified in order to ensure that a positive surgical excision margin is not incorrectly reported.

Control0..1
Typestring
Prostate.preAnalytic.clinicalHistory
Definition

Clinical history (including Gleason grade and score of previous specimens): - In many cases the clinical history will influence the ultimate diagnosis and may provide information which will assist in providing prognostic information. Specifically, the Gleason grade and score of prostate cancer in any previously submitted specimen should be provided. This permits assessment of any progression of the tumour towards a more undifferentiated state, which itself is of prognostic significance. - Symptoms due to prostate cancer are often nonspecific and are often similar to those of benign prostatic hyperplasia. Impotence, priapism or haemospermia may be the presenting feature but such cases are rare. Metastatic tumour is usually associated with bone pain and, in advanced disease, symptoms secondary to organ involvement may be the first clinical evidence of prostate cancer. Most organ-confined prostate cancers are asymptomatic. Approximately 25% of prostate cancers are diagnosed as a result of symptoms and in nearly all of these cases extraprostatic spread of tumour has occurred.

Control0..*
Typestring
Prostate.preAnalytic.previousTherapy
Definition

Previous therapy: Adjuvant radiation and endocrine therapy for prostate cancer has a profound effect on the morphology of both the cancer and the benign prostatic tissue. For this reason, information about any previous therapy is important for the accurate assessment of specimens. This applies to prostate biopsies taken to evaluate local disease or to salvage radical prostatectomy specimens; to transurethral resection of the prostate (TURP) undertaken to relieve obstructive symptoms; and to biopsies of metastatic tumour.

Control0..1
Typestring
Prostate.preAnalytic.psa
Definition

Pre-biopsy serum PSA is essential for stage grouping in the 7th Edition of the AJCC/UICC TNM staging system.15 In addition, pre-biopsy serum PSA is a key parameter in some nomograms widely used to estimate the risk of recurrence post-operatively and guide clinical decision making on adjuvant therapy.

Control0..*
TypeQuantity
Requirements

Units in ng/|mL.

Prostate.preAnalytic.stagingInfo
Definition

Relevant clinical information for clinicopathological staging: Clinical details about the anatomical extent of the tumour should be provided. For radical prostatectomy specimens the details should include a comment about the apparent completeness of resection, the presence or absence of clinically known metastatic disease and the site of any known metastases. Information relating to the presence or absence of extraprostatic tumour, as well as metastases, is rarely evident from examination of the surgical specimen, and details of this should be included in the specimen request form to facilitate accurate staging.

Control0..1
Typestring
Prostate.preAnalytic.pathologyAccessionNumber
Definition

The pathology accession number of the specimen must be recorded.

Control0..1
Typestring
Prostate.preAnalytic.principalClinician
Definition

The principle clinician can provide key information regarding the clinical presentation of the patient. Follow up may be required with the principle clinician for a number of reasons: - The clinical assessment and staging may be incomplete at the time of biopsy. Prostate cancer structured reporting protocol 2nd edition - The pathology request is often authored by the clinician performing the biopsy rather than the clinician who is investigating and managing the patient. - The identity of this clinician is often not indicated on the pathology request form In practice therefore, it is important in such cases that the reporting pathologist should be able to communicate with the managing clinician for clarification.

Control0..1
TypeReference(Practitioner)
Prostate.preAnalytic.comments
Definition

Comments: Included to encourage reporting of ambiguity, or for the addition of other comments.

Control0..1
Typestring
Prostate.macro
Definition

Macroscopic findings.

Control0..1
Comments

This is just a group/section header and is not a result field.

Prostate.macro.specimenWeight
Definition

Specimen weight (ie Prostate without seminal vesicles): The weight of the prostate gland without the seminal vesicles must be recorded. Weigh the prostate gland without the seminal vesicles. The seminal vesicles can vary markedly in size; thus, if only a combined weight is recorded, this will introduce error into the measurement of the prostate gland weight and distort comparisons with the radiologically estimated weight. Given this, a working group at the 2009 International Society of Urological Pathology (ISUP) Consensus Conference in Boston recommended that the prostate should be weighed following removal of the seminal vesicles.

Control1..1
TypeQuantity
Requirements

measurement in g.

Prostate.macro.specimenDimension1
Definition

Specimen dimensions of the prostate gland should be recorded in three dimensions (in millimetres). Measurements for apex to base, right to left and anterior to posterior enable comparison with clinical and imaging estimates of volume.

Control0..1
TypeQuantity
Requirements

measured in mm.

Prostate.macro.specimenDimension2
Definition

Specimen dimension 2 (mm).

Control0..1
TypeQuantity
Requirements

measured in mm.

Prostate.macro.specimenDimension3
Definition

Specimen dimension 3 (mm).

Control0..1
TypeQuantity
Requirements

measured in mm.

Prostate.macro.seminalVesicles
Definition

The presence or absence of seminal vesicles must be recorded.

Control0..1
BindingA code that idicates the presence (partially or completely resected) or absence of seminal vesicles
The codes SHALL be taken from ProstateRadSeminalVesiclesMacro
Typecode
Prostate.macro.lymphNodes
Definition

If lymph nodes are received, then they should be recorded.

Control0..1 This element is affected by the following invariants: null, null
InvariantsDefined on this element
01: If lymph nodes are present consider recording G2.20 (laterality & site(s) and numbers of lymph nodes) (: $this = 'present' implies lymphNodes.laterality.exists())
09: If lymph nodes are present record S3.07 lymph node status. (: $this = 'present' implies Prostate.micro.lymphNodeStatus.number.exists())
Prostate.macro.lymphNodes.code
Definition

If lymph nodes are received, then they should be recorded.

Control0..1
BindingA code that indicates if lymph nodes were present or absent
The codes SHALL be taken from PresentAbsentNa
Typecode
Requirements

Conditional: If received, record the number of nodes.

Prostate.macro.lymphNodes.laterality
Definition

If present, the laterality of the lymph nodes submitted may be recorded as left, right or bilateral.

Control0..1
BindingA code that indicates the laterality of lymph nodes
The codes SHALL be taken from Laterality
Typecode
Requirements

Conditional: If received, record the number of nodes.

Prostate.macro.lymphNodes.site
Definition

If present, record site and number. All lymph node tissue should be submitted for histological examination.

Control0..*
Typestring
Requirements

Note that the site and number of LNs for that site may need to be repeated for each site received.

Prostate.macro.lymphNodes.numLymphNodes
Definition

Numbers of lymph nodes from this site.

Control0..*
Typeinteger
Prostate.macro.lymphNodes.numLymphNodesPositive
Definition

Numbers of positive lymph nodes from this site.

Control0..*
Typeinteger
Prostate.macro.blockIdentificationKey
Definition

A block identification key listing the nature and origin of all tissue blocks should be recorded.

Control0..*
Typestring
Prostate.macro.otherMacroComments
Definition

A descriptive or narrative field should be provided to record any macroscopic information that is not recorded in the above standards and guidelines, and that would normally form part of the macroscopic description. The traditional macroscopic narrative recorded at the time of specimen dissection is often reported separately from the cancer dataset. Although this remains an option, it is recommended that macroscopic information be recorded within the overall structure of this protocol. Much of the information recorded in a traditional macroscopic narrative is covered in the standards and guidelines above and in many cases, no further description is required.

Control0..1
Typestring
Prostate.micro
Definition

Microscopy of the sample.

Control0..1
Comments

This is just a group/section header and is not a result field.

Prostate.micro.tumourType
Definition

Tumour type: The histological tumour type must be recorded. Choose from the following values taken from the World Health Organization Classification of Tumours. Pathology and Genetics of Tumours of the Urinary System and Male Genital Organs (2004).

Control1..* This element is affected by the following invariants: null, null
BindingA code for tumout type from a multi selection value list (select all that apply)
The codes SHALL be taken from ProstateRadTumourType
Typecode
InvariantsDefined on this element
02: If the histological tumour type is other, then record the other type. (: $this = 'other' implies tumourType.other.exists())
03: If the histological tumour type is Adenocarcinoma (Acinar variant eg foamy, pseudohyperplastic), then record the variant. (: $this = 'acinar_variant' implies tumourType.acinarVariant.exists())
Prostate.micro.tumourFocality
Definition

Tumour focality - the number of foci of tumour.

Control0..*
Typestring
Prostate.micro.tumourLocation
Definition

Tumour location Record in which quadrants tumour is present. (Specify for the dominant or largest tumour nodule, and also for other nodules >10 mm diameter, if present). Specify whether right anterior, right posterior, left anterior or left posterior.

Control0..1
Comments

This is just a group/section header and is not a result field.

Prostate.micro.tumourLocation.quadrant
Definition

Largest nodule located by quadrant.

Control0..1 This element is affected by the following invariants: null
BindingA code from a single selection value list for the largest nodule located by quadrant
The codes SHALL be taken from NoduleLocation
Typecode
Requirements

Single selection value list.

Prostate.micro.tumourLocation.plane
Definition

Largest nodule located by plane (eg apex, mid, base of prostate). This information is important for correlation with needle biopsy findings, imaging results, etc.

Control0..1
BindingA code from a single selection value list for the largest nodule located by plane
The codes SHALL be taken from ProstateRadNodulePlane
Typecode
Requirements

Single selection value list.

Prostate.micro.tumourLocation.otherNodule
Definition

Other nodules >10mm in diameter.

Control0..*
InvariantsDefined on this element
04: If there are other nodules >10mm in diameter then record the locations in quadrant and plane. (: $this = 'present' implies (describe.exists() or plane.exists()))
Prostate.micro.tumourLocation.otherNodule.code
Definition

Other nodules >10mm in diameter - type.

Control0..1
BindingA code from a single selection value list to indicate other nodules >10mm in diameter
The codes SHALL be taken from PresentAbsent
Typecode
Requirements

Single selection value list.

Comments

If present, record the locations in quadrant and plane.

Prostate.micro.tumourLocation.otherNodule.quadrant
Definition

Other nodules - locations by quadrant.

Control0..*
BindingA code from a multi selection value list (select all that apply) to indicate other nodule locations by quadrant
The codes SHALL be taken from NoduleLocation
Typecode
Requirements

Multi selection value list.

Prostate.micro.tumourLocation.otherNodule.plane
Definition

Other nodules - locations by plane.

Control0..*
BindingA code from a multi selection value list (select all that apply) to indicate other nodule locations by plane
The codes SHALL be taken from ProstateRadNodulePlane
Typecode
Requirements

Multi selection value list.

Prostate.micro.intraglandularExtent
Definition

The intraglandular extent should be recorded as a percentage. Some measurement of the size or extent of the tumour is typically given in histopathology reports for most sites and this parameter forms part of the generic ICCR dataset for all tumour types. However in prostate, while cancer volume is a prognostic factor on univariate analysis, it is significantly correlated with other clinicopathological features, including Gleason score, EPE, surgical margin status and pathological TNM stage, and the majority of studies have not demonstrated independent prognostic significance on multivariate analysis.30-35 Hence, the ICCR expert panel regarded this factor as a recommended (non-core) rather than required item. The irregular distribution and often multifocal nature of prostate cancer makes accurate calculation of tumour volume challenging for the pathologist in routine diagnostic practice; a situation where precise methods, such as computerised planimetry or image analysis, are too time and labour intensive to be practical. However, there was consensus at the 2009 ISUP Conference that some quantitative measure of the extent of the tumour in a prostatectomy specimen should be recorded. This can be done either as a visual estimate of intraglandular percentage of cancer or by measuring the maximum size of dominant tumour nodule. The latter has been shown to correlate with tumour volume and has also been recommended as a readily assessed surrogate for tumour volume in some studies and protocols.

Control0..1
TypeQuantity
Requirements

Numeric: __%.

Prostate.micro.sizeDominantNodule
Definition

The maximum size of the dominant nodule should be recorded in millimetres.

Control0..1
TypeQuantity
Requirements

Numeric: __mm.

Prostate.micro.histologicalGrade
Definition

The Histological grade using the Gleason grading system (ISUP 2005) must be recorded. The 2005 ISUP modified Gleason score is a required (core) element for all radical prostatectomy specimens containing adenocarcinoma, except for those showing morphological changes consistent with androgen withdrawal or significant radiation therapy changes. The Gleason grading system has been in use for over 40 years and is the current, internationally accepted grading system for prostate cancer. It has undergone several significant modifications over time, with an updated version developed at the 2005 ISUP Consensus Conference on Gleason Grading of Prostatic Carcinoma. The Gleason score is an important, independent predictor of tumour behaviour and is a key parameter in the tables and nomograms commonly used to guide decisions on clinical treatment.

Control0..1
Comments

This is just a group/section header and is not a result field.

Prostate.micro.histologicalGrade.primary
Definition

Primary Gleason grade.

Control1..1
BindingA code from a single selection value list for the Primary Gleeson Grade (numeric 1-5)
The codes SHALL be taken from GleesonGradePrimary
Typecode
Requirements

Numeric: ___ (1-5).

Prostate.micro.histologicalGrade.secondary
Definition

Secondary Gleason grade.

Control0..1
BindingA code from a single selection value list for the Secondary Gleeson Grade (numeric 1-5)
The codes SHALL be taken from GleesonGradeSecondary
TypeQuantity
Requirements

Numeric: ___ (1-5).

Prostate.micro.histologicalGrade.tertiary
Definition

Tertiary Gleason grade.

Control0..1
BindingA code from a single selection value list for the Tertiary Gleeson Grade (numeric 3-5)
The codes SHALL be taken from GleesonGradeTertiary
TypeQuantity
Requirements

Numeric: ___ (3-5) or Not applicable.

Prostate.micro.histologicalGrade.score
Definition

Gleason score.

Control0..1
Typestring
Prostate.micro.extraprostaticExtension
Definition

Extraprostatic extension information.

Control0..1
InvariantsDefined on this element
05: If an extraprostatic extension is present, then record the extent and consider recording the locations(s) of the EPE. (: $this = 'present' implies extraprostaticExtension.extent.exists())
Prostate.micro.extraprostaticExtension.code
Definition

Extraprostatic extension (EPE) must be recorded. Extraprostatic extension (EPE), defined as the extension of tumour beyond the confines of the gland into the periprostatic soft tissue, is a required (core) element of the ICCR dataset as it is a significant predictor of recurrence in node negative patients.30,53 EPE replaced earlier, less clearly defined terms, such capsular penetration, perforation or invasion, following a 1996 Consensus Conference. The assessment of EPE can be difficult, as the prostate is not surrounded by a discrete, well defined fibrous capsule,55 but rather of a band of concentrically placed fibromuscular tissue that is an inseparable component of the prostatic stroma. EPE can be recognised in several different settings: (1) the presence of neoplastic glands abutting on or within periprostatic fat or beyond the adjacent fat plane in situations where no fat is present in the immediate area of interest (most useful at the lateral, posterolateral and posterior aspects of the prostate) (See Fig. S3.03 (i) A below); (2) neoplastic glands surrounding nerves in the neurovascular bundle (posterolaterally); (3) the presence of a nodular extension of tumour bulging beyond the periphery of the prostate or beyond the compressed fibromuscular prostatic stroma at the outer edge of the gland—as there is often a desmoplastic reaction in the vicinity of EPE and the neoplastic extraprostatic glands may then be seen in fibrous tissue, rather than in fat. Extraprostatic tumour in fibrous tissue is best identified initially at low power magnification, but should be then confirmed by high power magnification examination verifying that the neoplastic glands are in stroma that is fibrous and beyond the condensed smooth muscle of the prostate (See Fig. S3.03 (i)B below). The presence of cancer within fibrous stroma that is in the same tissue plane as adipose tissue on either side is a helpful indictor of EPE.

Control1..1 This element is affected by the following invariants: null
BindingA code from a single selection value list for the extraprostatic extension
The codes SHALL be taken from ExtraprostaticExtension
Typecode
Requirements

Single selection value list.

Comments

If present, record S3.04 extent. If present, consider recording G3.04.

Prostate.micro.extraprostaticExtension.extent
Definition

The EPE extent must be reported as focal or non-focal. Categorisation of the extent of EPE as focal or nonfocal (also referred to as ‘established’ or ‘extensive’) is a required (core) item in the ICCR dataset. Focal EPE was originally defined no more than “a few “ neoplastic glands just outside the prostate, then subsequently, in a more semi-quantified manner, as extraprostatic glands which occupy no more than one high power field in no more than two sections, with extensive EPE representing anything more than this.30 More rigorous quantification of the extent of EPE by measuring the maximum distance that the tumour bulges beyond the outer edge of the fibromuscular prostatic stroma radially has been proposed by some investigators. However, the practical value of such parameters is limited by the difficulty in precisely defining the outer limit of the prostate gland, especially when the tumour is associated with a desmoplastic reaction. The identification of any EPE is important, as both focal and extensive EPE are associated with a significantly higher risk of recurrence at both 5 and 10 years.30,53 Following radical prostatectomy, the progression-free probability for node negative patients with uninvolved seminal vesicles at 10 years for organ confined disease is 85– 89%, falling to 67–69% for focal EPE and to 36–58% for extensive EPE.

Control0..1
BindingA code from a single selection value list for the extraprostatic extension extent
The codes SHALL be taken from FocalNonFocal
Typecode
Requirements

Single selection value list.

Comments

If present, record S3.04 extent. If present, consider recording G3.04.

Prostate.micro.extraprostaticExtension.location
Definition

The location of extraprostatic extension (EPE) may be recorded.

Control0..* This element is affected by the following invariants: null
BindingA code from a multi select value list (select all that apply) for the location(s) of EPE
The codes SHALL be taken from ProstateRadTumourLocations
Typecode
Requirements

Single selection value list.

Comments

If other, specify the other location.

InvariantsDefined on this element
06: If the location of the extraprostatic extension is other, then record the record the other locations(s) of the EPE. (: $this = 'other' implies locations.other.exists())
Prostate.micro.extraprostaticExtension.comment
Definition

Extraprostatic extension - other location Since it was considered a generic element forming part of a comprehensive pathology report, the location of any extraprostatic extension present has been included in the recommended (non-core) dataset, despite the lack of published evidence for its influence on staging, prognosis or treatment. It provides potentially useful information to the urologist, enabling correlation with clinical findings and any pre-operative imaging studies performed.

Control0..1
Typestring
Prostate.micro.margin
Definition

Margin status must be recorded.

Control0..1
Prostate.micro.margin.status
Definition

Margin status must be recorded. A positive surgical margin (PSM) significantly reduces the likelihood of progression-free survival, including PSA recurrence-free survival, local recurrence-free survival and development of metastases after radical prostatectomy in multivariate analysis. Moreover, positive margins are associated with a 2.6- fold increased unadjusted risk of prostate cancer specific mortality. Careful inking of the outer surface of the radical prostatectomy specimen before macroscopic dissection (grossing) greatly facilitates the determination of margin status. A PSM can then be defined as cancer extending to the inked surface of the specimen, representing a site where the urologist has cut through cancer (See Fig. S3.05 below). PSMs are reported in between 10 – 48% of patients treated by radical prostatectomy for both organ confined and non-organ confined prostate cancer with the rates in the lower range typically found in more modern cohorts.

Control1..1 This element is affected by the following invariants: null
BindingA code from a single selection value to indicate the involvement of the margin status
The codes SHALL be taken from MarginStatus
Typecode
Requirements

Single selection value list:.

InvariantsDefined on this element
07: If the margin status is involved, the record the location(s) and optionally the extent; the Gleason score at the margin and the type of positivity. (: $this = 'involved' implies location.other.exists())
Prostate.micro.margin.locationCode
Definition

Involved margin location Stating the location of the PSM is useful information for the urologist who can then modify future operations to avoid iatrogenic margin positivity and increase the likelihood of curative surgery. The site of the PSM and the number of positive margins have been shown to influence biochemical recurrence and risk of progression. For instance, a margin involving the bladder neck or the posterolateral surface of the prostate has a more significant adverse impact on prognosis than an involved apical or anterior margin.

Control0..*
BindingA code from a multi select value list (select all that apply) for location(s) on the invovled margins
The codes SHALL be taken from ProstateRadTumourLocations
Typecode
Requirements

Multi select value list (select all that apply):.

Prostate.micro.margin.locationDescription
Definition

Margin status - other location.

Control0..1
Typestring
Prostate.micro.margin.extent
Definition

The extent (total) of margin involvement may be recorded. Extent is measured as the linear cumulative length of all positive margins. Although a positive surgical marginal (PSM) has a significant adverse impact on the overall likelihood of progression-free survival, in most published series only about a third of individual patients with a PSM will experience biochemical recurrence. Studies aiming to better quantify the risk associated with a PSM have focussed on a number of factors such as number, location and extent of positive margins. However, the published data relating to these parameters are somewhat contradictory, and the expert panel considered that there is only sufficient evidence to include measurement of the length of margin involved by carcinoma as an element in the ICCR dataset at present. In particular, the 5 year PSA recurrence risk appears to be significantly greater when the length of the involved margin is 3mm or more, (53% versus 14%). However, in one series, Cao et al 1found that the linear length of a positive margin was an independent prognostic factor for organ confined tumours only, i.e. pT2 not pT3, while, another investigation found that the impact of a positive surgical margin after radical prostatectomy was greater in intermediate and high risk groups (based on Gleason score and pre-biopsy PSA) than in low risk patients.63 Further studies of such factors potentially affecting the impact of PSMs are required before there is sufficient evidence justifying their inclusion as required (core) data elements.

Control0..1
TypeQuantity
Requirements

Numeric: ___mm Notes: If more than 1 positive margin, record the cummulative length.

Comments

Conditional on margin involvement.

Prostate.micro.margin.score
Definition

Gleason score at involved margins may be recorded. Following review of feedback on the draft prostate cancer (radical prostatectomy) dataset and commentary, the expert panel has included the Gleason score of the tumour at the positive surgical margin as a recommended (non-core) element of the ICCR dataset. Three recently published papers have found that Gleason score or grade of the tumour at the positive surgical margin is an independent predictor of biochemical recurrence and may aid optimal selection of patients for adjuvant therapy. In one of these studies patients with Gleason grade 4 or 5 carcinoma (score 3+4, 4+3, 4+4 or 4+5) at a PSM had double the risk of PSA relapse compared to those with only Gleason grade 3 (score 3+3) at the margin. Moreover, men with Gleason score 3 at the PSM had a similar 5-year biochemical relapse-free survival rate to those with negative margins. Another study, restricted to men with dominant nodule Gleason score 7 and nonfocal EPE, also found that the grade of cancer at the site of a PSM was associated with biochemical recurrence. In the event there are multiple positive margins with differently scored cancers present, the highest score should be recorded.

Control0..1
TypeQuantity
Requirements

Numeric: Notes: If more than 1 positive margin, record the highest score.

Comments

Conditional on margin involvement.

Prostate.micro.margin.positivity
Definition

The type of margin positivity may be recorded. This should be recorded as: - EPE - Intraprostatic (capsular incision) Intraprostatic margin involvement or capsular incision (CI) occurs when the urologist inadvertently develops the resection margin within the plane of the prostate rather than outside the capsule. CI with a positive surgical margin is diagnosed when malignant glands are cut across adjacent to benign prostatic glands. In these cases, the edge of the prostate in this region is left in the patient. Data on the prognostic significance of CI vary among studies. According to the largest series published, a significantly higher recurrence rate is found in patients with CI/intraprostatic margin involvement than in patients with organ confined disease with negative margins, or focal EPE with negative margins, although CI has a significantly better outcome than that associated with nonfocal EPE and positive margins. Margin involvement associated with EPE is diagnosed when malignant glands in extraprostatic tissue are transected by the resection margin. This can be difficult to distinguish from capsular incision in some cases, particularly posteriorly and posterolaterally if there is a desmoplastic reaction. Cancer extending to a margin which is beyond the normal contour of the prostate gland, or beyond the compressed fibromuscular prostatic stroma at the outer edge of the prostate, can be diagnosed as a positive surgical margin with EPE, similarly to margin involvement when there is cancer in adipose tissue. At the apex, the histological boundaries of the prostate gland can be difficult to define and again EPE with a positive margin can be difficult to differentiate from CI/intraprostatic margin involvement. Hence, if carcinoma extends to an inked margin at the apex where benign glands are not transected, this is considered a positive margin in an area of EPE by some authors. In contrast, other authors, and the majority of survey participants at the 2009 ISUP Consensus Conference, believe there is no reliable method to diagnose EPE in sections from the prostatic apex.

Control0..*
BindingA code from a multi select value list (select all that apply) for the type of margin positivity
The codes SHALL be taken from ProstateRadMarginPositivity
Typecode
Requirements

Multi select value list (select all that apply):.

Comments

Conditional on margin involvement.

Prostate.micro.seminalVesicles
Definition

Presence or absence of seminal vesicle involvement must be recorded. State if seminal vesicles are involved or not involved. The expert panel included seminal vesicle invasion (SVI) as a required (core) element of the ICCR dataset as SVI is a well-established, independent, adverse prognostic factor58,88-89 and an integral component of the commonly used nomograms and tables that predict risk of post prostatectomy cancer recurrence. The finding of SVI at the time of radical prostatectomy is associated with a significantly increased risk of PSA recurrence and the presence of SVI and a positive surgical margin may also influence the response to adjuvant radiotherapy. Bilaterality and extent of extraprostatic SVI are not independently predictive of prognosis and were not included as required or recommended items in the ICCR dataset. Different definitions of seminal vesicle invasion have been used over the years complicating comparison of the published survival analyses.91,93 Older definitions including involvement of the adipose tissue or adventitia around the seminal vesicle are problematic with regard to distinction from EPE; while in other studies a distinction between intraprostatic and extraprostatic seminal vesicle invasion has not always been made, impeding comparisons between series. At the 2009 ISUP meeting, the proposal that SVI should be defined as carcinomatous invasion of the muscular wall of the seminal vesicle exterior to the prostate was endorsed (See Fig.S3.06 below). Only extraprostatic seminal vesicle is included in this definition of SVI, since it is difficult differentiating between intraprostatic seminal vesicle and ejaculatory duct invasion as these structures merge without a clear histological cut off. It was concluded that older definitions that include invasion of the adipose tissue around the seminal vesicle are imprecise and should be discarded. If one or more of the seminal vesicles are involved by cancer, specify whether left side, right side or both.

Control1..1 This element is affected by the following invariants: null
BindingA code from a single selection value to indicate the involvement of the seminal vesicles
The codes SHALL be taken from ProstateRadSeminalVesiclesMicro
Typecode
Requirements

Single selection value list:.

Comments

If involved, record side.

InvariantsDefined on this element
08: If the seminal vesicles are involved, then record the side. (: $this = 'involved' implies seminalVesicles.side.exists())
Prostate.micro.bladderNeck
Definition

Presence or absence of bladder neck involvement should be recorded. Microscopically, invasion of the urinary bladder neck can be identified when there are neoplastic glands within the thick smooth muscle bundles of the bladder neck in sections from the base of the prostate in the absence of associated benign prostatic glandular tissue (Fig. G3.08). Microscopic bladder neck involvement is a significant predictor of PSA-recurrence in univariate analysis, although not in multivariate modelling in most studies. Neoplastic glands intermixed with benign prostatic glands at the bladder neck margin is equivalent to capsular incision rather than true bladder neck invasion. In the 7th Edition of the AJCC Cancer Staging Manual microscopic bladder neck invasion is classified as stage pT3a disease since it has a similar biochemical recurrence free survival and cancer specific survival to patients with SVI or EPE.

Control0..1
BindingA code from a single selection value to indicate the involvement of the bladder neck
The codes SHALL be taken from ProstateRadBladderNeck
Typecode
Requirements

Single selection value list:.

Prostate.micro.lymphNodeStatus
Definition

Lymph node status must be recorded. State the number of lymph nodes examined and the number of positive lymph nodes. Lymph node involvement is a well established independent adverse prognostic factor and is an integral component of the commonly used nomograms that predict the risk of post prostatectomy disease recurrence. There is little published data on the prognostic significance of isolated tumour cells (clusters less than <200 μm in greatest dimension) in prostate cancer and insufficient evidence at present to support the routine use of immunohistochemistry as an ancillary technique in the identification of lymph node involvement.

Control0..1
Comments

This is just a group/section header and is not a result field This is conditional on receipt of LNs in S2.03.

Prostate.micro.lymphNodeStatus.number
Definition

Number of lymph nodes examined.

Control0..1
TypeQuantity
Requirements

Numeric: __.

Prostate.micro.lymphNodeStatus.numberPositive
Definition

Number of positive lymph nodes.

Control0..1 This element is affected by the following invariants: null
TypeQuantity
Requirements

Numeric: __.

Comments

If >0 consider recording G3.09 and G3.10.

InvariantsDefined on this element
10: If there are positive lymph nodes consider recording G3.09 laterality and G3.10 maximum dimension of largest deposit. (: empty() implies or (laterality.exists() or maxDimension.exists()))
Prostate.micro.lymphNodeStatus.laterality
Definition

The laterality of any lymph node involvement should be recorded.

Control0..1 This element is affected by the following invariants: null
BindingA code that indicates the laterality of lymph nodes
The codes SHALL be taken from Laterality
Typecode
Comments

Consider recording the site(s) of involved nodes.

InvariantsDefined on this element
11: If there are positive lymph nodes with indicated laterality consider recording the site(s) of the involved nodes. (: empty() implies laterality.exists())
Prostate.micro.lymphNodeStatus.sitesInvolved
Definition

The site(s) of involved lymph nodes may also be recorded.

Control0..1
Typestring
Prostate.micro.lymphNodeStatus.maxDimension
Definition

The maximum dimension of the largest lymph node deposit may be recorded. The diameter of the largest metastatic deposit correlated with distant metastasis and cancer-specific survival in two studies but not in another and this factor has been included in the recommended (non-core) dataset rather than as a required (core) item. There was consensus (81% respondents) at the 2009 ISUP Conference that that the diameter of the largest lymph node metastasis should be included in the pathology reports on radical prostatectomy specimens.

Control0..1
TypeQuantity
Requirements

Numeric: __.

Prostate.micro.lymphNodeStatus.invasion
Definition

Lymphovascular invasion should be recorded. Lymphovascular invasion is defined as the unequivocal presence of tumour cells within endothelial-lined spaces with no underlying muscular walls. Lymphatic and venous invasion should be assessed together due to the difficulties in distinguishing between the two by routine light microscopy and it is important that artefacts, such as retraction or mechanical displacement of tumour cells into vessels, are excluded. Immunohistochemistry for endothelial markers, e.g. CD31, CD34 or D2-40, may aid in the assessment of equivocal cases but is not recommended for routine use at present. Lymphovascular (LVI) invasion has been reported to be associated with decreased time to biochemical progression, distant metastases and overall survival after radical prostatectomy. Multivariate analysis, controlling for other pathological variables known to affect clinical outcome, showed that LVI is an independent predictor of disease recurrence in some studies. However, the independent prognostic value of LVI is uncertain as definitions of LVI have varied between studies and most included a substantial number of patients with lymph node metastases or SVI, failing to stratify patients into clinical meaningful categories. Further well designed studies with standardised definitions are necessary to confirm the independent prognostic significance of LVI.

Control0..1
BindingA code from a single selection value to indicate the extent of lymphovascular invasion
The codes SHALL be taken from NotIdentifiedPresentIndeterminate
Typecode
Prostate.micro.addtionalComment
Definition

Additional microscopic comment Comments should be included, if appropriate.

Control0..1
Typestring
Prostate.synthesisOverview
Definition

Synthesis and Overview are to be recorded Information that is synthesised from multiple modalities and therefore cannot reside solely in any one of the preceding chapters is described here. For example, tumour stage is synthesised from multiple classes of information – clinical, macroscopic and microscopic. By definition, synthetic elements are inferential rather than observational, often representing high-level information that is likely to form part of the ‘Summary’ or ‘Diagnosis’ section in the final formatted report. Overarching case comment is synthesis in narrative format. Although it may not necessarily be required in any given report, the provision of the facility for overarching commentary in a cancer report is essential.

Control0..1
Comments

This is just a group/section header and is not a result field.

Prostate.synthesisOverview.tumourStage
Definition

The tumour stage must be recorded according to the AJCC/UICC TNM system (7th edition).15 Used with the permission of the American Joint Committee on Cancer (AJCC), Chicago, Illinois. The original source for this material is the AJCC Cancer Staging Manual, Seventh Edition (2010) published by Springer Science and Business Media LLC, www.springerlink.com. The pathological tumour (T) and lymph node (N) categories were considered as generic required (core) elements for all ICCR cancer datasets Staging data should be assessed according to the most recent edition of the AJCC/UICC Staging Manuals (7th Edition)15 except pT2 subcategorization should be considered optional in line with ISUP recommendations as it lacks additional prognostic significance. The reference document: TNM Supplement: A commentary on uniform use, 4th Edition ( C Wittekind editor) may be of assistance when staging.

Control0..1
Typestring
Comments

This is just a sub-group/sub-section header and is not a result field.

Prostate.synthesisOverview.tumourStageT
Definition

Primary Tumour stage T is to be recorded. Note: 1) Invasion into the prostate apex or into (but not beyond) the prostate capsule is not classified as T3, but as T2. 2) There is no pathologic T1 classification for radical prostatectomy specimens 3) Positive surgical margin should be indicated by an R1 descriptor (residual microscopic disease).

Control0..1
BindingA code that records primary tumour stage T
The codes SHALL be taken from ProstateRadTuourStageT
Typecode
Requirements

Single selection value list.

Comments

Notes: 1. Invasion into the prostate apex or into (but not beyond) the prostate capsule is not classified as T3, but as T2. * There is no pathologic T1 classification for radical prostatectomy specimens Positive surgical margin should be indicated by an R1 descriptor (residual microscopic disease).

Prostate.synthesisOverview.tumourStageN
Definition

Regional lymph nodes (N) is to be recorded.

Control0..1
BindingA code that records regional lymph nodes stage N
The codes SHALL be taken from ProstateRadTuourStageN
Typecode
Requirements

Single selection value list.

Prostate.synthesisOverview.tumourStageM
Definition

Distant metastasis (M) is to be recorded Note: When more than one site of metastasis is present, the most advanced category is used. pM1c is most advanced.

Control0..1
BindingA code that records distant metastasis stage M
The codes SHALL be taken from ProstateRadTuourStageM
Typecode
Requirements

Single selection value list.

Prostate.synthesisOverview.tumourStage.stagingSystemDetails
Definition

The year of publication and edition of the cancer staging system used in S5.01 must be included in the report.

Control0..1
Typestring
Requirements

Numeric: year AND/OR Text: Edition eg 1st, 2nd etc.

Comments

Cardinality changed to 0..1 as none of the example reports provided this information. Query change to mandatory once the reporting community is more aware of the protocol requirements.

Prostate.synthesisOverview.diagnosticSummary
Definition

The ‘Diagnostic summary’ section of the final formatted report should include: a. nature of specimen (S1.02) b. tumour type (S3.01) c. Gleason score (S3.02) d. tumour stage (S5.01 & S5.02) e. whether or not the specimen margins are involved (S3.05).

Control0..1
Typestring
Prostate.synthesisOverview.overarchingComment
Definition

The reporting system must provide a field for free text or narrative in which the reporting pathologist can give overarching case comment. This field may be used, for example, to: - explain the decision-making pathway, or any elements of clinicopathological ambiguity, or factors affecting diagnostic certainty, thereby allowing communication of diagnostic subtlety or nuance that is beyond synoptic capture - give recommendations for further action or investigation - document further consultation or results still pending. Note: Use of this field is at the discretion of the reporting pathologist.

Control0..1
Typestring
Requirements

Conditional.