Prostate Cancer Specification - Local Development build (v0.1.0) built by the FHIR (HL7® FHIR® Standard) Build Tools. See the Directory of published versions
Clinical Context
This page provides an overview of the prostate and prostate cancer. It is based on the German S3 Guideline on Prostate Cancer (long version 8.1, 2025, hereinafter S3), the current EAU Guidelines on Prostate Cancer 2025 (hereinafter EAU), and the ICCR Prostate Cancer Datasets (hereinafter ICCR).
S3 Guideline on Prostate Cancer (long version 8.1)
EAU Guidelines on Prostate Cancer 2025
ICCR Prostate Cancer Datasets (2nd/3rd edition, November 2024)
Structured pathology reporting and the ICCR
The International Collaboration on Cancer Reporting (ICCR) is a joint initiative of pathology societies from the USA, UK, Canada and Australia, founded in 2011 to develop internationally agreed, evidence-based datasets for structured cancer pathology reporting. These datasets define which elements — both core (required) and non-core (recommended) — should be included in pathology reports for specific specimen types.
For prostate cancer, the ICCR publishes three datasets that directly correspond to the four example scenarios in this Implementation Guide:
The ICCR forms serve as the primary source for the pathology findings and observations modelled in this Implementation Guide. Where the S3 or EAU guidelines address pathology reporting, their recommendations are consistent with the ICCR elements.
What is the prostate?
The prostate is a small gland of the male reproductive system located below the urinary bladder, directly in front of the rectum (S3, pp. 32 f.). It surrounds the initial part of the urethra and produces a secretion that forms part of the seminal fluid (S3, pp. 32 f.). The gland increases in size with age, which can lead to urinary symptoms even independently of cancer (S3, pp. 32 f.).
What is prostate cancer?
In prostate cancer (prostate carcinoma), cells of the prostate become malignant and start to grow uncontrollably (S3, pp. 32 f.). In the vast majority of cases, these are acinar adenocarcinomas, i.e. glandular cancers (S3, pp. 93 f.; EAU, p. 90). Prostate cancer is one of the most common cancers in men in Europe and occurs mainly at an older age (S3, p. 32; EAU, p. 82). Many tumours grow slowly but, depending on their spread and aggressiveness, can become life-threatening (S3, p. 103; EAU, pp. 85 f.).
Frequency and risk factors
- Frequency
- Prostate cancer is the second most common cancer in men worldwide (EAU, p. 82).
- In Germany, it is among the most frequent tumours, especially in men over 60 years of age (S3, p. 32).
- Important risk factors
- Increasing age: the risk rises markedly with advancing age (S3, pp. 32 f.; EAU, p. 82).
- Family history, particularly first-degree relatives with prostate cancer (S3, p. 33; EAU, pp. 88 f.).
- Certain genetic changes, e.g. BRCA2 mutations (S3, p. 33; EAU, pp. 88 f.).
There are no proven measures that can reliably prevent prostate cancer, although a healthy lifestyle is recommended (S3, p. 37; EAU, p. 82).
Early detection (screening)
The aim of early detection is to identify clinically relevant tumours in time while at the same time avoiding overdiagnosis and overtreatment (S3, pp. 40 ff.; EAU, p. 88). The main basis is the measurement of prostate-specific antigen (PSA) in the blood after counselling about benefits and risks (S3, pp. 40–44; EAU, pp. 88 f.).
- German S3 guideline
- Men from 45 years of age with a life expectancy of at least 10 years should be offered a PSA test after unbiased counselling (S3, recommendations 4.2, 4.3; pp. 40–44).
- Digital rectal examination is no longer recommended for pure early detection (S3, recommendation 4.1; pp. 40 f.).
- EAU guideline
- Recommends individual, risk-adapted PSA-based early detection for well-informed men with an expected life expectancy of at least 15 years (EAU, p. 88).
- Earlier and more intensive screening is advised in men at increased risk (e.g. family history, BRCA2 mutation, men of African ancestry) (EAU, p. 88).
An elevated PSA value does not automatically mean prostate cancer but may be a reason for further diagnostic work-up (S3, pp. 42 ff.; EAU, pp. 87 f.).
Diagnostic work-up if prostate cancer is suspected
If prostate cancer is suspected (e.g. due to elevated PSA), several components are used (S3, pp. 53 ff.; EAU, pp. 87–91).
- History and physical examination
- Assessment of symptoms, comorbidities and family history (S3, pp. 40 f.).
- Digital rectal examination of the prostate via the rectum to assess size and consistency (S3, pp. 40 f.; EAU, pp. 82 f.).
- Imaging (MRI)
- Multiparametric MRI (mpMRI) of the prostate should be performed before biopsy from a confirmed PSA value ≥ 3 ng/mL, if this has therapeutic consequences (S3, recommendation 4.12; pp. 54 f.).
- MRI findings are standardised using PI‑RADS; higher categories indicate a higher probability of a clinically significant tumour (S3, pp. 54–57; EAU, pp. 90 f.).
- Tissue sampling (biopsy)
- A diagnosis of prostate cancer can only be confirmed by histological examination of biopsy samples (S3, pp. 93 ff.; EAU, pp. 87 f., 90).
- A combination of targeted biopsy of MRI-suspicious areas and systematic biopsy is recommended (S3, recommendations 4.16–4.21; pp. 55–57; EAU, pp. 90–92).
- The transperineal approach is preferred, as it is associated with a lower risk of infections (S3, recommendations 4.30 f.; pp. 59 f.; EAU, pp. 91–93).
The pathology report includes, among other things, tumour type, tumour extent and ISUP grade group, which describes the aggressiveness (S3, pp. 96 ff.; EAU, p. 90).
Classification and risk groups
For treatment decisions, it is crucial how far the tumour has progressed and how aggressive it is (S3, pp. 78–83, 103 ff.; EAU, pp. 83–86).
TNM system
The TNM classification describes:
- T (primary tumour) – extent of the tumour within the prostate and into neighbouring structures (EAU, p. 83).
- T1: non-palpable tumour, e.g. detected only in biopsy (EAU, p. 83).
- T2: palpable tumour confined to the prostate (EAU, p. 83).
- T3: tumour extends through the capsule or involves the seminal vesicles (EAU, p. 83).
- T4: infiltration of adjacent organs such as bladder neck or rectum (EAU, p. 83).
- N (lymph nodes) – regional lymph node involvement (EAU, p. 84).
- M (distant metastases) – e.g. in bones or other organs (EAU, p. 84).
Histological grade (ISUP/Gleason)
Aggressiveness is assessed using the microscopic appearance (Gleason score, ISUP grade) (S3, pp. 96–103; EAU, p. 85).
- ISUP grade 1: Gleason score 6 (≤ 3+3).
- ISUP grade 2: Gleason score 7 (3+4).
- ISUP grade 3: Gleason score 7 (4+3).
- ISUP grade 4: Gleason score 8.
- ISUP grade 5: Gleason score 9–10 (EAU, p. 85; S3, pp. 96 f.).
Higher grade groups are typically associated with a less favourable prognosis (S3, pp. 103 f.; EAU, pp. 85 f.).
Risk groups
To estimate the risk of recurrence and metastasis, risk groups are defined that combine PSA, ISUP grade and T stage (S3, pp. 79–83; EAU, p. 86).
Example of EAU risk groups for localised/locally advanced disease (simplified):
- Low risk
- ISUP 1, PSA ≤ 10 ng/mL and cT1–2a (EAU, Table 3, p. 86).
- Intermediate risk
- e.g. ISUP 2–3 or PSA 10–20 ng/mL or cT2b (EAU, Table 3, p. 86; S3, Table 11, p. 81).
- High risk / locally advanced
- ISUP 4–5, PSA ≥ 20 ng/mL, cT2c or cT3–4 or cN+ (EAU, Table 3, p. 86; S3, Table 11, p. 81).
This classification guides recommendations for active surveillance, surgery or radiotherapy (S3, chapter 6; EAU, pp. 96–104).
Treatment goals and decision-making
The goals of treatment are prolonging life, preventing or alleviating symptoms and maintaining quality of life (S3, pp. 107 f., 359 ff.; EAU, p. 119 f.). The choice of therapy depends on tumour stage, aggressiveness, comorbidities, life expectancy and patient preferences (S3, pp. 107–111; EAU, pp. 82, 96 ff.).
Both guidelines emphasise shared decision-making after thorough counselling on the benefits and risks of each option, particularly regarding continence, sexual function and quality of life (S3, pp. 107–111, 359 ff.; EAU, p. 119 f.).
Treatment of localised prostate cancer
Localised means that the tumour is confined to the prostate without lymph node or distant metastases (S3, pp. 78 f.; EAU, p. 86). In this setting, watchful approaches, surgery and radiotherapy are available (S3, chapter 6; EAU, pp. 96–104).
Active surveillance
Active surveillance is aimed at men with low-risk tumours and longer life expectancy (S3, pp. 116–129; EAU, pp. 97–99).
- The tumour is closely monitored using PSA, and if needed MRI and repeat biopsies; no immediate treatment is carried out (S3, pp. 116–120; EAU, pp. 97–99).
- The aim is to avoid or delay surgery or radiotherapy as long as the tumour remains stable (S3, pp. 116 ff.; EAU, pp. 97–99).
- If there are signs of progression, treatment with curative intent is initiated (S3, pp. 118–120; EAU, pp. 98 f.).
S3 primarily recommends active surveillance for localised low-risk prostate cancer (S3, recommendation 6.6; pp. 116 f.). EAU considers active surveillance the standard option for low-risk tumours (EAU, pp. 97–99).
Surgical and endoscopic procedures on the prostate
As part of the diagnosis and treatment of prostate cancer, different procedures on the prostate are used. They have different goals: some are used to confirm the diagnosis, others aim at cure, others mainly at relieving urinary symptoms.
Prostate core needle biopsy (CoreNeedleBiopsy)
Prostate core needle biopsy is a diagnostic procedure.
- When is it performed?
It is performed when there is a justified suspicion of prostate cancer, for example due to an elevated PSA value, an abnormal digital rectal examination or suspicious lesions on multiparametric MRI. It can also be used during follow-up in the context of active surveillance.
- Why is it performed?
Only a tissue sample can reliably show whether prostate cancer is present and how aggressive it is (ISUP grade/Gleason score). These findings are crucial for staging and treatment planning.
- What is done?
Under image guidance (usually ultrasound, often with MRI fusion), a thin hollow needle is used to take several small cylinders of tissue (“cores”) from different regions of the prostate. Today, a transperineal approach is often used to reduce the risk of infection. The removed tissue is then examined under the microscope in a pathology laboratory.
Radical prostatectomy (RadicalProstatectomy)
Radical prostatectomy is a curative surgical procedure.
- When is it performed?
It is used for localised or selected locally advanced prostate cancer when there is a realistic chance of cure and life expectancy is sufficiently long.
- Why is it performed?
The goal is to remove the tumour completely. The removed organ also allows for very precise pathological examination, which provides important information for prognosis and the need for additional treatments.
- What is done?
The entire prostate and the seminal vesicles are removed, and depending on the patient’s risk profile, lymph nodes in the pelvis may also be removed. The operation can be performed as open surgery, laparoscopically or with robotic assistance. Where oncologically feasible, nerve-sparing techniques are used to better preserve continence and erectile function.
Transurethral enucleation of the prostate (TransurethralEnucleation, e.g. HoLEP/ThuLEP)
Transurethral enucleation is mainly a function-improving procedure for a markedly enlarged prostate; it can also be used in men with prostate cancer to relieve urinary symptoms.
- When is it performed?
It is used in men with significantly enlarged prostates and pronounced urinary symptoms (e.g. weak stream, residual urine, repeated urinary retention), especially in large glands. In the context of prostate cancer, it is considered when there is a relevant narrowing of the urethra in addition to the tumour that needs to be treated.
- Why is it performed?
The aim is to remove the inner, obstructing part of the prostate (the adenoma) almost completely in order to relieve the urethra and significantly improve urine flow. In patients with prostate cancer, the main goal is usually symptom relief, not complete tumour removal.
- What is done?
Using an endoscope inserted through the urethra, special instruments (often a laser, for example in HoLEP) are used to separate and “shell out” the inner prostate tissue from the outer capsule. The freed tissue is then pushed into the bladder, fragmented (morcellated) and removed. The tissue is examined histologically and can provide information about known or incidentally detected prostate cancer.
Transurethral resection of the prostate (TURP, TransurethralResection)
TURP is an established standard procedure for benign prostate enlargement, and in prostate cancer it is mainly used palliatively to relieve symptoms.
- When is it performed?
It is used in men with significant urinary problems due to narrowing of the urethra by an enlarged prostate, for example in urinary retention or recurrent urinary tract infections. In advanced or metastatic prostate cancer, TURP can be needed when rapid relief of bladder outlet obstruction is necessary.
- Why is it performed?
The aim is to improve urine flow, reduce residual urine and prevent complications such as urinary retention or infections. In the context of prostate cancer, TURP is not intended to cure the cancer but to relieve symptoms and improve quality of life.
- What is done?
Through an endoscope passed via the urethra, an electrical loop is used to shave off the inner prostate tissue layer by layer; the removed “chips” of tissue are flushed out. This tissue is also examined histologically and can provide information about the presence and extent of prostate cancer.
Radiotherapy
Radiotherapy can be carried out as external beam radiotherapy (percutaneous radiotherapy) or internal radiotherapy (brachytherapy) (S3, pp. 139–155; EAU, pp. 100–101).
- Modern external radiotherapy uses IMRT/VMAT and IGRT to better spare the bladder and rectum (S3, pp. 139–145; EAU, pp. 100 f.).
- In intermediate- and high-risk groups, radiotherapy is often combined with short- to medium-term androgen deprivation therapy (S3, pp. 139–151; EAU, pp. 100–103).
- Side effects may affect bowel function, bladder function and sexual function (S3, pp. 139–145, 359 ff.; EAU, p. 119 f.).
If the tumour has extended beyond the prostatic capsule, involves lymph nodes or has formed distant metastases, this is referred to as locally advanced or metastatic prostate cancer (S3, pp. 78 f., 205 ff.; EAU, pp. 86, 95–96). In this situation, systemic therapies are central, often in combination with local treatment (S3, chapter 7; EAU, pp. 104–113).
Androgen deprivation therapy (ADT)
Prostate cancer cells usually grow in a testosterone-dependent manner, so androgen deprivation slows their growth (S3, pp. 212–216, 253 ff.; EAU, pp. 108 ff.).
- This can be achieved medically with LHRH analogues/antagonists and antiandrogens, or less commonly by surgical removal of the testes (S3, pp. 212–214; EAU, pp. 108 f.).
- In hormone-sensitive metastatic prostate cancer, ADT is now usually combined with additional drugs (e.g. abiraterone, apalutamide, enzalutamide, darolutamide or docetaxel) in patients who are fit enough (S3, pp. 225–232; EAU, pp. 108–110).
- Typical side effects include hot flushes, fatigue, weight gain, loss of muscle mass, increased risk of osteoporosis and metabolic changes (S3, pp. 310–325; EAU, pp. 117–118).
Other systemic therapies
In advanced or castration-resistant stages, additional therapies are used (S3, pp. 253–278; EAU, pp. 110–113).
- Modern hormone therapies (androgen receptor signalling inhibitors such as enzalutamide, apalutamide, darolutamide, abiraterone) (S3, pp. 253–267; EAU, pp. 110–113).
- Chemotherapy, especially with docetaxel and cabazitaxel (S3, pp. 259–267; EAU, pp. 111 f.).
- Radioligand therapy, e.g. with lutetium‑177‑PSMA (S3, recommendation 7.51; pp. 268 ff.; EAU, pp. 112 f.).
- PARP inhibitors in the presence of proven DNA repair defects (e.g. BRCA2) (S3, p. 323 f.; EAU, pp. 111 f.).
The choice depends on previous treatments, comorbidities, genetic findings and patient preferences (S3, pp. 253–278; EAU, pp. 110–113).
Follow-up and quality of life
After curative-intent treatment (surgery or radiotherapy), regular follow-up is important (S3, pp. 352–356; EAU, p. 117).
- PSA is used as a sensitive marker for possible recurrence (S3, pp. 352–356; EAU, p. 117).
- Imaging is usually only performed if it would have therapeutic consequences (S3, p. 352 f.; EAU, p. 117).
Quality of life, continence, sexual function, and psychological and social aspects are explicitly highlighted in both guidelines (S3, chapters 8–10; EAU, p. 119 f.). Recommended measures include rehabilitation, physical activity, psycho-oncological support and, where appropriate, participation in self-help groups (S3, pp. 343–351, 359–362; EAU, pp. 119 f., 120).
Key terms at a glance
| Term |
Meaning in simple words |
| PSA |
Blood value produced by the prostate; elevated levels can, among other things, indicate prostate cancer (S3, pp. 42 ff.; EAU, pp. 87 f.). |
| Biopsy |
Tissue sampling with a needle for microscopic (histological) diagnosis (S3, pp. 93 ff.; EAU, pp. 87–92). |
| ISUP grade / Gleason score |
Measure of how aggressive the tumour cells look under the microscope (S3, pp. 96–103; EAU, p. 85). |
| TNM |
International system for classifying tumour size, lymph node involvement and distant metastases (EAU, pp. 83–84; S3, pp. 78 f.). |
| Active surveillance |
Close monitoring without immediate treatment in low-risk tumours (S3, pp. 116–120; EAU, pp. 97–99). |
| Radical prostatectomy |
Operation to completely remove the prostate (S3, pp. 136–138; EAU, pp. 99–103). |
| Radiotherapy |
Treatment with high-energy radiation to destroy tumour cells (S3, pp. 139–155; EAU, pp. 100–103). |
| Androgen deprivation |
Hormone therapy that reduces the effect of testosterone on tumour cells (S3, pp. 212–216, 253 ff.; EAU, pp. 108 ff.). |
Note on the use of this
This information is intended to help users of this specification better understand the medical context. The content is based on the S3 Guideline on Prostate Cancer (long version 8.1, 2025) and the EAU Guidelines 2025.