Nubeqa qith ADT for prostate cancer – pro
ARANOTE was a multicenter, double-blind, placebo-controlled, phase III study in 669 patients with mCSPC. Patients were randomized 2:1 to receive 600 mg NUBEQA twice daily (N=446) or placebo (N=223) concomitantly with ADT. Treatment with NUBEQA or placebo continued until progressive disease, change of antineoplastic therapy, unacceptable toxicity, death, or withdrawal. The primary endpoint was radiographic progression-free survival (rPFS), defined as the time from randomization to radiological disease progression or death by central blinded review. rPFS was statistically significant for the NUBEQA arm vs placebo arm (HR: 0.54; 95% CI: 0.41-0.71; P<0.0001).
ADT consisted of, “All patients started ADT of the investigator’s choice (luteinizing hormone-releasing hormone agonist or antagonist or orchiectomy) within 12 weeks before initiating study treatment.”
Saad F, Vjaters E, Shore N, Olmos D, Xing N, Pereira de Santana Gomes AJ, Cesar de Andrade Mota A, Salman P, Jievaltas M, Ulys A, Jakubovskis M, Kopyltsov E, Han W, Nevalaita L, Testa I, Le Berre MA, Kuss I, Haresh KP; ARANOTE Study Investigators. Darolutamide in Combination With Androgen-Deprivation Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer From the Phase III ARANOTE Trial. J Clin Oncol. 2024 Dec 20;42(36):4271-4281. doi: 10.1200/JCO-24-01798. Epub 2024 Sep 16. PMID: 39279580; PMCID: PMC11654448.
Hussain M, Tombal B, Saad F, et al. Darolutamide plus androgen-deprivation therapy and docetaxel in metastatic hormone-sensitive prostate cancer by disease volume and risk subgroups in the phase III ARASENS trial. J Clin Oncol. 2023;41:3595–3607. doi: 10.1200/JCO.23.00041