ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable)

Exclusion criteria

1. Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire. Nota Bene: (Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable). 2. Eastern Cooperative Oncology Group (ECOG) performance status score ≥3. 3. Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure \[BP\] ≥160 mmHg or diastolic BP ≥95 mmHg; 3 consecutive measures taken 5 minutes apart). 4. Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or baseline before randomisation, with the exception of hot flushes and erectile dysfunction. 5. Previous systemic treatment for prostate cancer, except less than 12 weeks of ADT and/or an old-generation AR inhibitor. 6. Severe or uncontrolled concurrent disease, infection or co-morbidity. 7. Known hypersensitivity to the study treatment or any of its ingredients. 8. Major surgery within 28 days before randomisation. 9. Any of the following within 6 months before randomisation: stroke, myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft; congestive heart failure New York Heart Association (NYHA) Class III or IV. 10. Prior malignancy ≤3 years before study enrolment. Adequately treated basal cell or squamous cell carcinoma of skin or superficial bladder cancer that has not spread behind the connective tissue layer (i.e., pTis, pTa, and pT1) is allowed, as well as any localized cancer for which treatment has been completed ≥6 months before randomisation and from which the subject has been disease-free, or for which the risk of relapse is less than 30%, as well as early stage chronic lymphocytic leukaemia that does not require any specific treatment. 11. Inability to swallow oral medications. 12. Gastrointestinal disorder or procedure that can be expected to interfere significantly with the absorption of study treatment. 13. Known to have active viral hepatitis, active human immunodeficiency virus (HIV) or chronic liver disease at screening. 14. Treatment with any investigational product within 28 days before randomisation. 15. Concurrent participation in another clinical trial involving an investigational product (patients enrolled in non-experimental trials with no modification of the standard of care can be included). 16. Individual deprived of liberty or placed under the authority of a tutor. 17. Significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition that, in the opinion of the investigator, would preclude participation in this trial.