NCT06015321

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

Open Label Trial of Maintenance Enzalutamide in CRPC

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: Male
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Detailed description

1. Patients will receive docetaxel 40 mg/m2 IV every 2 weeks plus ADT. Docetaxel will be repeated on an outpatient basis and continued until disease progression, unacceptable toxicity, deterioration of clinical condition, patient refusal, or up to 6 to 8 cycles. ADT includes commercially available GNRH agonists such as goserelin, leuprolide and triptorelin, according to their market authorized approved label. 2. After the receipt of 6 to 8 cycles of first-line docetaxel plus ADT, patients with no evidence of disease progression (i.e., biochemical and clinical) will receive enzalutamide 160 mg PO daily. Enzalutamide will be continued until disease progression (i.e., development of mCRPC), unacceptable toxicity, deterioration of clinical condition, patient refusal.

Conditions

• Prostatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Enzalutamide	enzalutamide 160 mg PO daily

Timeline

• Start date: 2023-10-01
• Primary completion: 2025-10-31
• Completion: 2026-04-30
• First posted: 2023-08-29
• Last updated: 2023-08-29

Locations

1 site across 1 country: South Korea