Advanced and metastatic prostate cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up
- Study type
- Clinical guideline
- Study name
- ESMO 2026
- Design
- Clinical guideline of the European Society for Medical Oncology (ESMO) with levels of evidence (I to V), grades of recommendation (A to E) and ESMO-MCBS scores
- Source
- Ann Oncol · 2026
In plain words
This guideline from the European Society for Medical Oncology says that in prostate cancer that has spread, hormone therapy on its own is not enough and should be combined with a newer hormone tablet (and, in widespread disease, sometimes chemotherapy); genetic testing is needed for every patient with advanced disease; and targeted and radioligand treatments are chosen based on the results of these tests and a PSMA scan. Regular exercise is also part of treatment.
Key guideline recommendations
- I, A
ADT plus an ARPI (abiraterone, apalutamide, enzalutamide or darolutamide) is strongly recommended for patients with low-volume de novo mCSPC (on conventional imaging).
- II, A
ADT–docetaxel–ARPI (triplet therapy) is recommended for patients with high-volume de novo mCSPC who are fit for docetaxel chemotherapy; the recommended duration of docetaxel is six cycles.
- II, A
Radiotherapy to the primary tumour plus systemic therapy is recommended for patients with low-volume de novo mCSPC.
- I, D
ADT alone and ADT–docetaxel (without an ARPI) are generally not recommended for mCSPC.
- III, A
Germline testing is recommended for patients with mCSPC. Genomic testing for alterations in BRCA1, BRCA2, CDK12 and PALB2 (at a minimum) is recommended for all patients with CRPC, preferably before the first treatment for mCRPC.
- I, A
In patients with BRCA alterations (germline or somatic) who have not previously received an ARPI, enzalutamide–talazoparib, abiraterone–niraparib or abiraterone–olaparib is recommended (some of these combinations are FDA-approved but not EMA-approved in this setting).
- I, A
In mCRPC without HRR alterations previously treated with docetaxel and an ARPI, 177Lu-PSMA-617 is recommended for patients with at least one PSMA-positive lesion on PSMA-PET and no PSMA-negative lesions (ESMO-MCBS: 5).
- I, B
In mCRPC without HRR alterations previously treated with an ARPI, 177Lu-PSMA-617 can be recommended for patients with PSMA-positive lesions who are not immediate candidates for docetaxel (FDA-approved, not EMA-approved).
- I, A
ADT plus apalutamide, darolutamide or enzalutamide is recommended for patients with high-risk nmCRPC (PSA doubling time under 10 months and life expectancy over 5 years), if not used previously.
- III, A
Patients receiving ADT should do combined aerobic and resistance exercise, supervised for at least 12 weeks and unsupervised thereafter.
Study population
Patients with metastatic castration-sensitive prostate cancer (mCSPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-resistant prostate cancer (mCRPC).
Clinical significance and place in guidelines
The latest ESMO guideline (2026) for advanced prostate cancer, which summarises the results of trials such as ARASENS, PEACE-1, TALAPRO-2, AMPLITUDE, VISION and PSMAfore as treatment algorithms based on disease volume, timing of metastasis, HRR status and PSMA expression.
Limitations
Some recommendations rest on level III or lower evidence; drug approval status differs between the FDA and EMA, and local access may vary. The recommendation text was translated from the pre-publication version (Journal Pre-proof) and may have minor editorial changes in the final version.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.