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

Summary

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.

Timeline

Start

2023-10-01

Primary completion

2025-10-31

Completion

2026-04-30

Drugs

Indications