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

Trial 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

NCT ID: NCT06015321

Condition: Prostatic Adenocarcinoma

Conditions: Official terms:
Adenocarcinoma
Prostatic Neoplasms

Study type: Interventional

Study phase: Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Enzalutamide
Description: enzalutamide 160 mg PO daily
Arm group label: Enzalutamide

Other name: XtandiTM

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - For inclusion of a subject in the study, all of the following inclusion criteria must be fulfilled: 1. Subject is a male at least 20 years of age. 2. Subject has a histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate. 3. Subject has radiologic and clinical evidence of metastatic disease initially or after treatment for localized disease. They must have metastatic or progressive disease for which there is no further curative treatment available. 4. Subject has an ECOG performance status of 0 to 1. 5. Subject has a life expectancy of 3 months or more. 6. At least 4 weeks since the last surgical procedures or radiotherapy prior to enrolment. Subjects must have recovered to Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1. 6. Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery. 7. Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy. 8. Subjects who have exhibited allergic reactions to taxanes. 9. Concomitant disease or condition that could interfere with the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study. 10. The subject has legal incapacity or limited legal capacity. Dementia or significantly altered mental status that would limit the understanding or rendering of informed consent and compliance with the requirements of this protocol. Unwillingness or inability to comply with the study protocol for any reason.

Gender: Male

Gender based: Yes

Gender description: Subject is a male at least 20 years of age

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Samsung Medical Center

Address:
City: Seoul
Zip: 06531
Country: Korea, Republic of

Contact:
Last name: Mijin Lee

Phone: 82-2-2008-4436

Investigator:
Last name: Sung Hee Lim, MD, Ph.D.
Email: Principal Investigator

Start date: October 1, 2023

Completion date: April 30, 2026

Lead sponsor:
Agency: Samsung Medical Center
Agency class: Other

Source: Samsung Medical Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06015321