Ignite Creation Date:
2024-05-05 @ 5:27 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459654
Status:
COMPLETED
Last Update Posted:
2014-06-25
First Post:
2007-04-11
Brief Title:
A Placebo-controlled Phase II Study of Bone-targeted Radium-223 in Symptomatic Hormone-refractory Prostate Cancer
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
A Phase II Randomised Placebo-controlled Multicentre Study in Prostate Cancer Patients With Painful Bone Metastases to Evaluate the Efficacy of Repeated Radium-223 Injections
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223 in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment
Detailed Description:
Primary objective
To study the biological effectiveness of radium-223 therapy measured as
Time to occurrence of skeletal-related eventsSREs
Change in bone-specific alkaline phosphatase bone-ALP levels
Secondary objectives
To study the efficacy of radium-223 therapy in terms of
Frequency of new SREs
Proportions of patients with an SRE
Proportions of patients with SRE at different time points
Changes of biochemical markers of bone turnover
Treatment response with regard to pain and analgesic usetermed Palliative effect in study protocol
Quality of life assessment
Overall survival To study the safety of the repeated radium-223 regimen Total Enrollment64 Study start February 2004
To study the biological effectiveness of radium-223 therapy measured as
Time to occurrence of skeletal-related eventsSREs
Change in bone-specific alkaline phosphatase bone-ALP levels
Secondary objectives
To study the efficacy of radium-223 therapy in terms of
Frequency of new SREs
Proportions of patients with an SRE
Proportions of patients with SRE at different time points
Changes of biochemical markers of bone turnover
Treatment response with regard to pain and analgesic usetermed Palliative effect in study protocol
Quality of life assessment
Overall survival To study the safety of the repeated radium-223 regimen Total Enrollment64 Study start February 2004
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BC1-02 | OTHER | Algeta ASA | None |