check_circleStudy Completed
Hormone Refractory Prostate Cancer, Bone Metastases
Bayer Identifier:
15305
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
BAY88-8223, does response study in HRPC patients
Trial purpose
The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
Key Participants Requirements
Sex
MaleAge
40 YearsTrial summary
Enrollment Goal
100Trial Dates
May 2005 - October 2009Phase
Phase 2Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoPrimary Outcome
- Pain Assessment (using a 100mm Visual Analogue Scale)date_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- Analgesic consumptiondate_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Reduction of pain: the pain dimension of Quality of Life assessed using the Brief Pain Inventory (BPI) form, with total pain score and subtotals, after injection and compared to scores at baselinedate_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- Duration of pain relief: measured as the time between the first and last evaluation time points at which the pain response criteria were metdate_rangeTime Frame:16 weeksenhanced_encryptionNoSafety Issue:
- The safety of radium-223: the total safety profile including adverse events and clinical laboratory measurements, with emphasis on haematological toxicity. Adverse events will be recorded continuously during the study period.date_rangeTime Frame:2 yearsenhanced_encryptionYesSafety Issue:
- The date of death (if within 24 months after the injection of study drug)date_rangeTime Frame:2 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
4