Lithuanian Prostate Diagnostics Implementation Guide
0.0.1 - ci-build
Lithuanian Prostate Diagnostics Implementation Guide
0.0.1 - ci-build
Lithuanian Prostate Diagnostics Implementation Guide, published by Lithuanian Medical Library. This guide is not an authorized publication; it is the continuous build for version 0.0.1 built by the FHIR (HL7® FHIR® Standard) CI Build. This version is based on the current content of https://github.com/HL7LT/ig-lt-prostate/ and changes regularly. See the Directory of published versions
The prostate cancer workflow is a structured, longitudinal process supporting early detection, risk stratification, and diagnosis. It transitions from population-based laboratory screening to advanced lesion-level imaging, culminating in multidisciplinary clinical decisions (including laboratory, imaging, radiology assessment, and pathology reporting).
In the digital ecosystem, this is represented by a Prostate Programme Report, which pairs a structured DiagnosticReport (the data anchor) with a Composition (the human-readable narrative). Earlier steps use LT Base, LT VitalSigns, LT Lab, and LT Lifestyle for demographics, vitals, labs, pathology workflows and behavioural data where applicable.
The ADPP (Early Diagnosis and Prevention Programme) tracks participants via ScreeningCarePlanLtProstate, which captures enrolment status, risk group, and scheduled activities.
| Criteria | Standard group | Increased risk group |
|---|---|---|
| Sex | Male | Male |
| Age | 50–69 years (inclusive) | 45–49 years (inclusive) |
| Family history | — | Father or brother diagnosed with prostate cancer |
| Periodicity | PSA every 2 years | PSA every 2 years |
Special rules:
Family history is captured using FamilyMemberScreeningHistoryLtLifestyle from LT Lifestyle with SNOMED situation codes (414205003 prostate, 429740004 breast, 2301000119106 ovarian, 312824007 colon cancer).
| PSA result | Age | Action |
|---|---|---|
| PSA < 1 ng/ml | up to 59 years | Re-invite after 5 years (T16) |
| PSA 1–3 ng/ml | up to 69 years | Re-invite after 2 years (T17) |
| PSA < 1 ng/ml | 60–69 years | Exit programme — no longer invited (T18) |
| PSA > 3 ng/ml | any | Referral to urologist (T19, form E027) |
Contextual Data: Supporting information such as age, trends over time, lifestyle factors (e.g., tobacco or alcohol use from LT Lifestyle profiles), and anthropometrics and vitals (use LT VitalSigns profiles — BodyHeight, BodyWeight, BMI) are linked to provide clinical context. Anticoagulant use is captured via MedicationStatementLtLifestyle.
The programme uses the following ESPBI electronic forms for referrals:
| Step | Form | Description | Questionnaire |
|---|---|---|---|
| T19 | E027 | Referral to urologist | ADPP Questionnaire |
| T22 | E027 | Referral to radiologist for mpMRI | Radiologist Referral Questionnaire |
| T26 | E014 | Referral to pathologist (biopsy order) | Pathologist Referral Questionnaire |
| T29 | E090/a | First-time oncological diagnosis report | — |
If indicated by PSA levels or clinical risk, a prostate MRI—either biparametric (bpMRI) or multiparametric (mpMRI) — is performed.
Radiologists identify and score individual lesions using the PI-RADS framework.
Lesion Identification
Each lesion is treated as a structured anatomical entity using the PI-RADS 39-sector model, documenting:
Sequence & PI-RADS Scoring
For each identified lesion, individual sequence scores (T2W, DWI, ADC, and DCE) are assigned. These culminate in the PI-RADS Assessment, representing the likelihood of clinically significant cancer for that specific lesion.
All findings are compiled into a coherent programme record. This record consists of two primary technical components:
| Component | Resource Type | Content |
|---|---|---|
| Data Report | DiagnosticReport | Structured result list of Observations (PI-RADS, PI-QUAL, sequence scores, etc.) |
| Narrative | Doc Composition | Human-readable sections: Findings, Impression, and Recommendations. |
Note: Pathology results (Gleason/ISUP) are linked via the Encounter or supportingInfo but remain mastered within the LT Lab pathology workflow to avoid data duplication.
If MRI reveals high-risk (PI-RADS 4-5) or concerning intermediate (PI-RADS 3) lesions, a biopsy is performed.
For patients in Active Surveillance, repeat MRIs are monitored using the PRECISE framework.
The workflow maintains a strict separation between Assessment (the data) and Decision (the action).
For a single exchangeable imaging-class record aligned with LT Base ImagingReportLt, this guide defines ProstateReportLtProstate and ProstateCompositionLtProstate. The DiagnosticReport lists Observation results (PSA-related data may appear in supportingInfo; PI-RADS, PI-QUAL, PRECISE, etc. in result). The Composition uses the imaging composition section layout (study, order, history, procedure, comparison, findings, impression, recommendation). Pathology DiagnosticReport is not placed in result (see DiagnosticReportLt); link it via LT Lab bundles or encounter as in the prostate report page.
Examples in this IG
Specialised mpMRI profile: MpMRIReportLtProstate remains the EU ImDiagnosticReport-aligned profile for detailed mpMRI exchange; use ProstateReportLtProstate when the national ImagingReport pattern is required.
National ESPBI forms (including pathology report fields aligned with programme spreadsheets) can be represented as Questionnaire / QuestionnaireResponse — see Questionnaires for coverage vs source spreadsheets, ConceptMap mappings to LT profiles, and examples. They are orthogonal to ProstateReport / Composition.
Illustrative published examples for measurements and behaviour often linked from programme assessment:
The following sections expand how lesion-level and exam-level assessments are modelled in this IG (profiles and observations).
The workflow typically begins with Prostate-Specific Antigen (PSA) testing. The PSA result is captured as a structured laboratory Observation and often triggers further evaluation.
If further evaluation is indicated, a prostate MRI examination is ordered (bpMRI or mpMRI). During acquisition, the patient is present; data represent technical acquisition only.
The radiologist reviews MRI sequences and identifies one or more prostate lesions, with localisation using the PI-RADS 39-sector model, zone, level, side, and position.
For each lesion, SequenceScoreLtProstate observations capture T2, DWI, ADC, and optionally DCE scores.
PIRADSAssessmentLtProstate gives a lesion-level PI-RADS category. Multiple lesions may have different scores.
PiqualObservationLtProstate is an exam-level image quality score.
Beyond lesion scoring, the mpMRI report must assess whether the tumour extends beyond the prostate itself. Two profiles capture this:
NeoplasmInvasionLtProstate records direct invasion into peri-prostatic structures:
| Structure | SNOMED | Laterality | Certainty |
|---|---|---|---|
| Prostatic capsule | 60405008 | Right / Left | Expected (suspected) / Indisputable (present) |
| Seminal vesicles | 64739004, 279669004 | Right / Left / Base | Expected / Indisputable |
| Neurovascular bundles | 59820001 | Right / Left | Expected / Indisputable |
| Regional lymph nodes | 312500006 | Right / Left | Present (+ free text for location and size) |
BladderChangesLtProstate records bladder changes with two components:
ProstateDamageAndChangeStatusVS)ProstateChangeNatureVS)PelvicOrganChangesLtProstate records rectal and other pelvic organ changes:
| Structure | SNOMED | Notes |
|---|---|---|
| Rectum | 34402009 | Tumour-related or other |
BoneMetastasisLtProstate records bone metastatic assessment separately (code: SNOMED 94222008 "Secondary malignant neoplasm of bone").
Both profiles reference a BodyStructure instance (EU BodyStructure) using codes from BodyStructureProstateVS. Each BodyStructure instance carries the anatomical structure code and optional laterality. The observation value uses ProstateDamageAndChangeStatusVS (Absent / Suspected / Present).
The Excel mpMRI requirements distinguish laterality (right, left, base for seminal vesicles) and certainty (Expected vs Indisputable) for each invaded structure. These are captured as follows:
includedStructure.laterality (SNOMED 24028007 Right, 7771000 Left). For seminal vesicle base, a distinct SNOMED code (279669004) is used instead of laterality.ProstateDamageAndChangeStatusVS:
Each combination of structure + laterality + certainty produces a separate NeoplasmInvasionLtProstate observation referencing its own BodyStructure instance. For example, "Capsule — Expected: right" creates one observation with value=Suspected referencing a BodyStructure with capsule + right laterality.
A separate BodyStructure profile is not defined for these structures — the EU BodyStructure profile with BodyStructureProstateVS binding is sufficient. This contrasts with LesionLtProstate, which has its own profile because intra-prostatic lesions require the 39-sector PI-RADS map and morphology constraints.
Examples:
The mpMRI and PRECISE forms include an optional section for other prostate conditions observed alongside the primary assessment. Use ProstateOtherConditionsLtProstate to record these incidental findings with structured SNOMED codes from ProstateOtherConditionsVS:
| Condition | SNOMED |
|---|---|
| Nodular hyperplasia | 266569009 |
| Prostatitis | 9713002 |
| Fibrotic changes | 263756000 |
The binding is extensible, so free-text descriptions can be provided via valueCodeableConcept.text when no standard code applies. Include these in ProstateReportLtProstate.result.
Findings are compiled into a structured report. Use MpMRIReportLtProstate for EU-aligned mpMRI reports, or ProstateReportLtProstate for the ImagingReportLt programme anchor.
Clinical assessment is separated from workflow decisions (referral, biopsy). PI-RADS drives actions such as surveillance vs biopsy referral.
Biopsy is performed using BiopsyProcedureLtLab from LT Lab. Biopsy orders follow PathologyOrderLtLab. Specimens are tracked via SpecimenLtLab and SpecimenBlockLtLab. Pathology results are structured in PathologyReportLtLab with PathologyCompositionLtLab. TNM staging uses ProstateConditionLtLab.
Additional lab observations: SpecimenAdequacyLtLab (specimen quality), SpecimenMeasurementLtLab (bioptate length), TumorObservableLtLab (tumour characteristics).
Perineural and lymphovascular invasion are captured as structured items in the pathology Questionnaire with coded answer options (present / not identified / ambiguous / cannot evaluate) and optional free-text notes. The pathology ConceptMap maps these items to LT Lab tumour finding Observations (SNOMED 369731000 perineural present, 370051000 absent; 385414009 lymphovascular invasion).
Full pathology workflow: LT Lab pathology workflow.
PreciseAssessmentLtProstate summarises change vs a prior MRI (regression, stability, progression).
The structured model supports PSA trends, serial MRI, PRECISE, and integration with pathology for shared decision-making.
flowchart LR
step1[PrimaryAssessment]
step2[MRIAcquisition]
step3[RadiologyPIRADS]
step4[BiopsyDecision]
step5[Pathology]
step6[ManagementFollowUp]
step1 --> step2
step2 --> step3
step3 --> step4
step4 --> step5
step5 --> step6
step6 --> step3
The loop from ManagementFollowUp back to RadiologyPIRADS reflects repeat MRI and surveillance over time.