An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Chemo-Naïve patients with Progressive Prostate Cancer who have failed Androgen Deprivation Therapy (CRPC patients)
Phase 2
Completed
- Conditions
- metastatic prostate cancer10027476
- Registration Number
- NL-OMON45038
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
Adult metastatic prostate cancer patients who are progressive on first-line ADT for metastatic disease and who have at least one measurable metastasis on either 18F-FDG PET/CT or WB MRI or both.
Exclusion Criteria
Previous chemotherapy, impaired liver/kidney/bone marrow function, susceptibility for seizures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method