An Exploratory Phase 2, open-label, single-arm, efficacy and imaging Study of Oral Enzalutamide (MDV3100) Androgen Receptor (AR)-Directed Therapy in Hormono-Sensitive patients with Metastatic Prostate Cancer.
Phase 2
Completed
- Conditions
- metastatic prostate cancer10038364
- Registration Number
- NL-OMON50224
- 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 hormone-sensitive prostate cancer patients with progressive
metastatic disease requiring treatment and who have at least one measurable
metastasis on either PET/CT or WB MRI or both.
Exclusion Criteria
Previous androgen deprivation therapy within the last 6 months / Known or
suspected brain metastasis or active leptomeningeal disease / Evidence of
clinically relevant liver/kidney disease/bone marrow failure / history of
seizure or any condition that may predispose to seizure / history of loss of
consciousness or transient ischemic attack within 12 months of enrollment /
Contra-indication for MRI (e.g. pacemaker).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method