Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015321
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-08-29
First Post:
2023-08-23
Brief Title:
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
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Open Label Trial of Maintenance Enzalutamide in CRPC
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although surgical or medical castration ie 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 12 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 34 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 56 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 mgm2 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 ie biochemical and clinical will receive enzalutamide 160 mg PO daily Enzalutamide will be continued until disease progression ie development of mCRPC unacceptable toxicity deterioration of clinical condition patient refusal
2 After the receipt of 6 to 8 cycles of first-line docetaxel plus ADT patients with no evidence of disease progression ie biochemical and clinical will receive enzalutamide 160 mg PO daily Enzalutamide will be continued until disease progression ie development of mCRPC unacceptable toxicity deterioration of clinical condition patient refusal
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None