Phase 2
Completed N=60
Determine Effect of Enzalutamide (MDV3100) on the Androgen Signaling Pathway in Correlation With the Anti-tumor Effects of Enzalutamide
Metastatic Progressive Castration-resistant Prostate Cancer
Source: ClinicalTrials.gov NCT01091103 ↗
Enrolled (actual)
60
Serious AEs
21.7%
Results posted
Nov 2014
Primary outcomePrimary: Change From Baseline in Bone Marrow Testosterone — 0.05 ng/mL
Summary
This study is being conducted to determine the effect of enzalutamide on the androgen signaling pathway in correlation with the anti-tumor effects of enzalutamide to identify potential predictors of response or resistance to therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Bone Marrow Testosterone |
0.05 | — |
| PRIMARY Change From Baseline in Bone Marrow Dihydrotestosterone |
0.00 | — |
| PRIMARY Change From Baseline in Bone Marrow Testosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status |
0.05; 0.05 | 0.9427 |
| PRIMARY Change From Baseline in Bone Marrow Dihydrotestosterone at Week 9 by Prostate-Specific Antigen (PSA) Response Status |
-0.01; 0.00 | 0.3370 |
| SECONDARY Percentage of Participants at Week 9 With a Response in Prostate-Specific Antigen (PSA) |
41.1; 21.4 | — |
| SECONDARY Median Time to Study Drug Discontinuation |
5.0 | — |
| SECONDARY Change From Baseline in Urinary N-Telopeptide |
17.67 | — |
Eligibility Criteria
Inclusion Criteria
- Confirmed prostate cancer
- Presence of metastatic disease to the bone
- Ongoing androgen deprivation therapy
Exclusion Criteria
- Severe concurrent disease
- Metastases in the brain
Data sourced from ClinicalTrials.gov (NCT01091103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.