check_circleStudy Completed
Prostate Cancer, Neoplasm Metastasis
Bayer Identifier:
15304
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
BAY88-8223, dose finding study in pts with HRPC
Trial purpose
The purpose of this study is to evaluate the effectiveness of the investigational radioisotope Radium-223, Alpharadin, in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
Key Participants Requirements
Sex
MaleAge
18 YearsTrial summary
Enrollment Goal
122Trial Dates
May 2006 - December 2009Phase
Phase 2Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | The Royal Marsden Hospital | Sutton, SM2 5RT, United Kingdom |
Primary Outcome
- Proportion of participants in each dose group with a confirmed PSA responsePSA response; each patient will be classified as PSA responder/non-responder according to the definition of PSA response:a decrease from baseline of at least 50% maintained for at least three weeks.date_rangeTime Frame:24 weeks, 12 months, 24 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- The maximum percent decrease in PSA level compared to baselinedate_rangeTime Frame:24 weeks, 12 months, 24 monthsenhanced_encryptionNoSafety Issue:
- Time to PSA Progressiondate_rangeTime Frame:24 weeks, 12 months, 24 monthsenhanced_encryptionNoSafety Issue:
- Bone-ALP response (classified as for PSA response) and decrease in bone-ALP level compared to baselinedate_rangeTime Frame:24 weeks, 12 months, 24 monthsenhanced_encryptionNoSafety Issue:
- Total number of SRE per patientdate_rangeTime Frame:24 weeks, 12 months, 24monthsenhanced_encryptionNoSafety Issue:
- Pain Assessment and analgesic consumptiondate_rangeTime Frame:24 weeks, 12 months, 24monthsenhanced_encryptionNoSafety Issue:
- Time to death from first treatmentdate_rangeTime Frame:24 weeks, 12 months, 24monthsenhanced_encryptionNoSafety Issue:
- Time to Skeletal Related Events (SRE)date_rangeTime Frame:24 weeks, 12 months, 24 monthsenhanced_encryptionNoSafety Issue:
- Adverse events, blood chemistry and haematological toxicitydate_rangeTime Frame:24 weeks, 12 months, 24 monthsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
3