Phase 3
Completed N=1,199
Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy
Source: ClinicalTrials.gov NCT00974311 ↗Enrolled (actual)
1,199
Serious AEs
40.0%
Results posted
Oct 2012
Primary outcomePrimary: Overall Survival — 18.4; 13.6 Months — p=<0.0001
Summary
This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival |
18.4; 13.6 | <0.0001 sig |
| SECONDARY Radiographic Progression-free Survival |
8.3; 2.9 | <0.0001 sig |
| SECONDARY Time to First Skeletal-related Event |
16.7; 13.3 | 0.0001 sig |
| SECONDARY Percentage of Participants Who Were Responders for Functional Assessment of Cancer Therapy-Prostate (FACT-P) |
43.2; 18.3 | <0.0001 sig |
| SECONDARY Time to Prostate-specific Antigen (PSA) Progression |
8.3; 3.0 | <0.0001 sig |
| SECONDARY Percentage of Participants With Pain Palliation |
44.9; 6.7 | 0.0079 sig |
| SECONDARY Percentage of Participants With Prostate Specific Antigen (PSA) Response |
54; 2; 25; 1 | — |
| SECONDARY Percentage of Participants With Soft-tissue Objective Response |
29; 4 | — |
| SECONDARY European Quality of Life Five-Domain (EQ-5D) Scale |
67.2; 60.0 | — |
| SECONDARY Percentage of Participants With Circulating Tumor Cell (CTC) Conversion |
48; 9.7 | — |
Eligibility Criteria
Inclusion Criteria
- Progressive prostate cancer
- Medical or surgical castration with testosterone less than 50 ng/dl
- One or two prior chemotherapy regimens. At least one chemotherapy regimen must have contained docetaxel
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Adequate bone marrow, hepatic, and renal function
- Able to swallow the study drug and comply with study requirements
- Informed consent
Exclusion Criteria
- Metastases in the brain or active epidural disease
- Another malignancy within the previous 5 years
- Clinically significant cardiovascular disease
- Gastrointestinal disorder affecting absorption
Data sourced from ClinicalTrials.gov (NCT00974311). 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.