Phase 2
Completed N=312
ZD4054 (Zibotentan) in Pain-free or Mildly Symptomatic Patients With Prostate Cancer and Bone Metastases Who Have Rising Serum Prostate Specific Antigen (PSA)
Source: ClinicalTrials.gov NCT00090363 ↗Enrolled (actual)
312
Serious AEs
19.2%
Results posted
Sep 2012
Primary outcomePrimary: Time to Progression (TTP) — 111; 138; 113 Days
Summary
This study is being carried out to see if ZD4054 (Zibotentan) is effective in treating prostate cancer and spread of cancer to the bone, and if so, how it compares with placebo (sugar pill). The study will also provide further information on the safety of ZD4054 (Zibotentan).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Progression (TTP) |
111; 138; 113 | — |
| SECONDARY Time to Death |
596; 706; 717 | — |
| SECONDARY Change in Total Prostate Specific Antigen (PSA) Over Time |
110.4; 131.6; 69.34 | — |
| SECONDARY Objective Response Rate (ORR) |
0; 0; 0 | — |
| SECONDARY Change in Number of Bone Metastases Over Time |
187.1; 113.4; 189 | — |
Eligibility Criteria
Inclusion Criteria
- Surgically or medically castrated
- Bone metastasis
- Rising PSA
Exclusion Criteria
- Opiate use
- Prior chemotherapy
Data sourced from ClinicalTrials.gov (NCT00090363). 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.