Hungarian Society of Urology

Darolutamide – a new drug in the treatment of non-metastatic, castration-resistant prostate cancer

DOI: 10.22591/magyurol.2021.2.pikob.53

Pikó Béla dr.1, Bassam Ali dr.1, Mészáros Tibor dr.2, Laczó Ibolya dr.1,Veréb Blanka dr.1, Csikósné Mácsok Erzsébet1
1Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Megyei Onkológiai Központ, Gyula (centrumvezető: Pikó Béla dr.)
2Békés Megyei Központi Kórház Pándy Kálmán Tagkórház, Urológiai Osztály, Gyula (osztályvezető: Mészáros Tibor dr.)


Although patients with non-metastatic castration-resistant prostate cancer are usually asymptomatic, but the disease eventually progresses to metastatic in 60% of cases within 5 years. The management of the disease are provided by the new – or second – generation androgen receptor inhibitors (enzalutamide, apalutamide and, most recently, darolutamide), the efficacy of which has been demonstrated in similarly designed phase III. clinical trials (PROSPER, SPARTAN, ARAMIS).
Although the task of the oncoteam is not necessarily to suggest the statistically expected “most effective” drug based on the patient’s general condition, concomitant diseases, preferences, but to be the „safest” and „most acceptable” for the patient. Consideration may be that the relative hazard for mortality reduction for darolutamide was more favourable in the study (–31%) than in the studies with apalutamide (–22%) and enzalutamide (–27%).
Darolutamide has a flexible, polar molecular structure that binds with high affinity to wild-type and mutant androgen receptors and does not increase serum testosterone levels in monotherapy. Due to its structure, it crosses little through the blood-brain barrier, to a lesser extent than the other next-generation androgen receptor inhibitors. Its side effect profile is favourable.
However, direct comparative data of next-generation androgen receptor inhibitors are not available, Darolutamid can be considered an effective and safe agent based on the results of clinical trials.


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