Metastatic Castration-Resistant Prostate Cancer
Conditions
Keywords
MDV3100, prostate, cancer, enzalutamide
Brief summary
The purpose of this study is to investigate radiographic progression-free survival (PFS) of enzalutamide in chemotherapy-naïve patients with progressive metastatic castration-resistant prostate cancer who have symptomatic disease.
Interventions
DRUGEnzalutamide
oral
Sponsors
Medivation, Inc.
Astellas Pharma Global Development, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Progressive prostate cancer while on androgen deprivation therapy * Castrate testosterone level * Maintenance of surgical or medical castration for duration of study * Radiographically visible metastatic disease * Symptomatic from prostate cancer * Eastern Cooperative Oncology Group (ECOG) 0-2 * Life expectancy \>=6 months
Exclusion criteria
* Brain metastases or leptomeningeal disease * Prior cytotoxic chemotherapy for prostate cancer * Prior use of ketoconazole or abiraterone acetate or other investigational agent that blocks androgen synthesis or targets androgen receptor * History of seizure or condition that may predispose to seizure * History of loss of consciousness or transient ischemic attack within 12 months * Clinically significant cardiovascular disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic progression free survival (PFS) | 26 months | Time from first dose on Day 1 to the first objective evidence of radiographic progression or death due to any cause (whichever occurs first). Radiographic disease progression is defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and Prostate Cancer Clinical Trials Working Group 2 (PCWG2). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety assessed by recording of adverse events, safety laboratory evaluations, vital signs and electrocardiograms (ECGs) | 26 months | — |
| Overall survival | 26 months | Time from first dose on Day 1 to death due to any cause |
| Change from baseline to last post baseline measurement Pain Assessments (Brief Pain Inventory - Short Form) | Baseline and 26 months | Brief Pain Inventory is a validated instrument that is a subject self-rating scale assessing level of pain, effect of the pain on activities of daily living, and analgesic use |
| Change from baseline to last post baseline measurement Quality of life score using Functional Assessment of Cancer Therapy-Prostate (FACT-P) | Baseline and 26 months | The FACT-P quality of life questionnaire is a multi-dimensional, self-reported quality of life instrument specifically designed for use with prostate cancer patients |
| Change from baseline to last post baseline measurement Quality of Life score using European Quality of Life 5-Domain Scale (EQ-5D) | Baseline and 26 months | EQ-5D is a standardized instrument for use as a measure of health outcome. It provides a simple descriptive profile and a single index value for health status and is designed for self-completion by respondents |
| Time to PSA progression | 26 months | Time from first dose on Day 1 to first observation of PSA progression |
Outcome results
None listed