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NCT ID: NCT06015321 Not yet recruiting - Clinical trials for Prostatic Adenocarcinoma

An Open Label Phase II Study of First-Line Maintenance Enzalutamide Following Docetaxel Plus Androgen-Deprivation Therapy in Patients With Previously-Untreated, Metastatic, Castration-Naive Prostatic Adenocarcinoma

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

Although surgical or medical castration (i.e., androgen-deprivation therapy, ADT) is considered standard treatment in metastatic castration-naïve PC (mCNPC) patients, current guidelines have established the addition docetaxel or modern androgen receptor targeting agents (ARTAs; abiraterone acetate or enzalutamide) to ADT as the standard of care for patients with mCNPC [1,2]. One of the major challenges in the management of mCNPC includes balancing the toxicity of first-line docetaxel with clinical benefit. Our previous clinical studies suggested that the tolerability of docetaxel could be improved by using a biweekly regimen [3,4], without compromising efficacy. There is a growing interest in maintenance therapy as a strategy for prolonging the benefit of first-line therapy while minimizing long-term toxicity. In phase III trials involving first-line enzalutamide in mCNPC (ENZAMET and ARCHES), earlier treatment with docetaxel was permitted [5,6]. Based on these considerations, we hypothesized that enzalutamide maintenance therapy would improve outcomes in patients who had received first-line biweekly docetaxel plus ADT for mCNPC.