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

NCT06015321 | Not Yet Recruiting Phase 2

• 1 other identifier: 2023-07-103
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Prostatic Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Time-to-CRPC (biochemical or clinical)

  RECIST v1.1 criteria will be used to assess patient response to treatment

  up tp 30months

Study Arms (1)

Enzalutamide

EXPERIMENTAL

First-Line Maintenance Enzalutamide Following Docetaxel plus Androgen-Deprivation Therapy in Patients with Previously-Untreated, Metastatic, Castration-Naïve Prostatic Adenocarcinoma

Drug: Enzalutamide

Interventions

Enzalutamide DRUG

enzalutamide 160 mg PO daily

Also known as: XtandiTM

Enzalutamide

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: Subject is a male at least 20 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is a male at least 20 years of age.
• Subject has a histologically or cytologically confirmed diagnosis of adenocarcinoma of prostate.
• 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.
• Subject has an ECOG performance status of 0 to 1.
• Subject has a life expectancy of 3 months or more.
• At least 4 weeks since the last surgical procedures or radiotherapy prior to enrolment. Subjects must have recovered to \<Grade 2 from all acute toxicities or toxicity must be deemed irreversible by the investigator.
• Acceptable liver function:
• Acceptable renal function
• Acceptable hematologic status (without growth factor support or transfusion dependency):
• Subject must agree to use an adequate method of contraception (condom) if he is having sex with a woman of childbearing potential or with a woman who is pregnant.
• Written and voluntary informed consent understood, signed and dated.

You may not qualify if:

• Ongoing treatment with an anticancer agent not contemplated in this protocol
• Pathologic finding consistent with neuroendocrine or small cell carcinoma
• Any history of clinically relevant coronary artery disease or myocardial infarction within the last 3 years, New York Heart Association (NYHA) grade III or greater congestive heart failure, cerebrovascular attack within the prior year, or current serious cardiac arrhythmia requiring medication except atrial fibrillation.
• Known uncontrolled brain, leptomeningeal or epidural metastases (unless treated and well controlled for at least 4 weeks prior to Cycle 1 Day 1). Subjects that develop brain metastasis during the study may have their treatment interrupted to receive a course of cranial radiation and restart trial medication after a recovery period of at least 1 week. High dose corticosteroids may be employed for the management of cranial radiation but must be tapered off before resuming treatment.
• Non-tolerable \>Grade 2 neuropathy or evidence of unstable neurological symptoms within 4 weeks of Cycle 1 Day 1.
• Major surgery, other than diagnostic surgery, within 4 weeks prior to Cycle 1 Day 1, without complete recovery.
• Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy.
• Subjects who have exhibited allergic reactions to taxanes.
• 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.
• 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.

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, Korea, 06531, South Korea

Location

MeSH Terms

Interventions

enzalutamide

Central Study Contacts

Sung Hee Lim, MD,Ph.D.

CONTACT

10-2018-9305; sunghee1022.lim@samsung.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Samsung Medical Center

Study Record Dates

• First Submitted: August 23, 2023
• First Posted: August 29, 2023
• Study Start: October 1, 2023
• Primary Completion: October 31, 2025
• Study Completion: April 30, 2026
• Last Updated: August 29, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR

Locations

KR (1)