This trial is active, not recruiting.

Condition metastatic castration-resistant prostate cancer
Treatment enzalutamide
Phase phase 4
Target androgen receptor
Sponsor Astellas Pharma Europe B.V.
Collaborator Medivation, Inc.
Start date May 2014
End date March 2017
Trial size 215 participants
Trial identifier NCT02116582, 2013-002271-17, 9785-CL-0410


The objective of this study is to evaluate the efficacy and safety of enzalutamide treatment in patients with progressive metastatic castration-resistant prostate cancer previously treated with abiraterone acetate.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
enzalutamide MDV3100

Primary Outcomes

Radiographic progression-free survival (rPFS)
time frame: until subject discontinuation (up to 2 years)

Secondary Outcomes

Overall Survival (OS)
time frame: until subject discontinuation (up to 2 years)
Prostate-specific antigen (PSA) response
time frame: until subject discontinuation (up to 2 years)
Time to PSA progression
time frame: until subject discontinuation (up to 2 years)
Safety assessed through evaluation of Adverse Events and Serious Adverse Events, safety laboratory tests, physical examination and vital signs
time frame: Time from signing informed consent to 30 days after last dose of study drug.

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Subject has histologically confirmed adenocarcinoma of the prostate without neuro-endocrine differentiation or small cell features. - Subject has metastatic disease documented by bone scan or by soft tissue disease observed by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) at screening, or within ≤30 days prior to Day 1. - In the setting of castrate levels of testosterone ≤1.7 nmol/L (or ≤50 ng/dL), subject has progressive disease at study entry defined as PSA rise determined by a minimum of 2 rising PSA levels with an interval of ≥ 1 week between each assessment. The PSA value at the screening visit should be ≥ 2 ng/mL WITH or WITHOUT: - Soft tissue disease progression defined by Response Evaluation Criteria In Solid Tumors (RECIST 1.1) at screening, or within ≤30 days prior to Day 1. Measurable disease is not required for entry. Lymph nodes ≥ 2 cm are considered measurable disease (Prostate Cancer Clinical Trials Working Group (PCWG2)). - Bone disease progression defined by at least 2 new lesions on bone scan at screening, or within ≤30 days prior to Day 1. - Subject must have received a minimum of 24 weeks of treatment with abiraterone acetate within its approved label indication and has discontinued use at least 4 weeks prior to start of study drug at Day 1. - If the subject has received previous treatment with chemotherapy for prostate cancer, this must be limited to no more than one prior line of docetaxel, and must have been used prior to abiraterone acetate therapy. - Subject receives and will continue to receive ongoing androgen deprivation with Luteinizing-hormone-releasing hormone (LHRH) analogue therapy throughout the course of the study or has had a bilateral orchiectomy. - Subject is asymptomatic or mildly symptomatic from prostate cancer: - The score on Brief Pain Inventory - Short Form (BPI-SF) Question #3 must be < 4. - No use of opiate analgesics for prostate cancer-related pain currently or anytime within 4 weeks prior to screening. Exclusion Criteria: - Subject has prior use of ketoconazole for the treatment of prostate cancer. - Subject has prior use of cabazitaxel. - Subject has prior use of enzalutamide. - Subject has received ANY anti-neoplastic therapy (including antiandrogens and chemotherapy) following abiraterone acetate discontinuation and prior to start of study drug at Day 1. - Subject has a known or suspected hypersensitivity to enzalutamide, or any components of the formulation used. - Subject has known or suspected brain metastases or active leptomeningeal disease. - Subject has history of seizure or any condition that may predispose to seizure (e.g., prior stroke or significant brain trauma).

Additional Information

Official title A Multi-center, Single Arm Study of Enzalutamide in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Astellas Pharma Inc.