Determine the Effect of MDV3100 on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of MDV3100 to Identify Potential Predictors of Response or Resistance to Therapy
This study is being conducted to determine the effect of MDV3100 on the androgen signaling pathway in correlation with the anti-tumor effects of MDV3100 to identify potential predictors of response or resistance to therapy.
Metastatic Progressive Castration-resistant Prostate Cancer
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Study of Continuous Oral Dosing of a Novel Antiandrogen MDV3100, in Castration-Resistant Bone Metastatic Prostate Cancer Patients Evaluating the Tumor Micro-Environment.|
- To explore the effect of treatment with MDV3100 on androgen signaling and expression of survival/escape pathways in the bone marrow [ Time Frame: 9 weeks post baseline ] [ Designated as safety issue: No ]To explore the effect of treatment with MDV3100 on androgen signaling and expression of survival/escape pathways in the bone marrow of patients with castration-resistant metastatic prostate cancer in correlation with measures of antitumor activity to identify predictors of response or resistance to therapy.
- To explore the antitumor activity of treatment with MDV3100. [ Time Frame: 9 weeks post baseline ] [ Designated as safety issue: No ]To explore the antitumor activity of treatment with MDV3100 as assessed by serum prostate-specific antigen (PSA) levels, imaging of soft tissue and bone metastases, and markers of bone metabolism;
|Study Start Date:||February 2010|
|Primary Completion Date:||September 2011 (Final data collection date for primary outcome measure)|
MDV3100 160 mg orally daily
MDV3100, 160 mg orally per day