check_circleStudy Completed
Prostatic Neoplasms
Bayer Identifier:
15397
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Radium-223 dichloride Asian population study in the treatment of CRPC patients with bone metastasis
Trial purpose
To evaluate the safety and efficacy (Overall survival [OS]) of multiple doses of Ra-223 dichloride in an Asian population of subjects with CRPC metastatic to the bone.
Key Participants Requirements
Sex
MaleAge
18 - N/ATrial summary
Enrollment Goal
243Trial Dates
March 2013 - September 2017Phase
Phase 3Could I Receive a placebo
NoProducts
Xofigo (Radium-223 dichloride, BAY88-8223)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Singapore, 169610, Singapore | |
Completed | Singapore, 258499, Singapore | |
Completed | Singapore, 119228, Singapore | |
Completed | Singapore, Singapore | |
Completed | Taipei, 10002, Taiwan | |
Completed | Taoyuan, 333, Taiwan | |
Completed | Taipei City, 112, Taiwan | |
Completed | Kaohsiung, 81362, Taiwan | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Seoul, 03080, Korea, Republic Of | |
Completed | Donggu,, 61469, Korea, Republic Of | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Shanghai, 200433, China | |
Withdrawn | Beijing, 100191, China | |
Withdrawn | Beijing, 100034, China | |
Completed | Beijing, 100730, China | |
Withdrawn | shanghai, 200032, China | |
Completed | Shanghai, 200032, China | |
Completed | Guangzhou, China | |
Completed | Shanghai, 200127, China | |
Completed | Shanghai, 200072, China | |
Completed | Beijing, 100029, China | |
Completed | Guangzhou, 510060, China | |
Completed | Beijing, 100021, China | |
Completed | Nanjing, 210008, China | |
Completed | Nanjing, 210009, China | |
Completed | Beijing, 100050, China | |
Completed | Shanghai, 200040, China | |
Completed | Beijing, 100020, China | |
Completed | Guangzhou, 510080, China |
Primary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilitydate_rangeTime Frame:Up to 36 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with laboratory changesdate_rangeTime Frame:Up to 36 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with changes in vital signsdate_rangeTime Frame:Up to 36 monthsenhanced_encryptionYesSafety Issue:
- Number of participants with changes in electrocardiogram (ECG)date_rangeTime Frame:Up to 36 monthsenhanced_encryptionYesSafety Issue:
- Overall Survival (OS)OS is defined as the time from date of first study drug treatment to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.date_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Changes in total Alkaline Phosphate (ALP) in serumdate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Number of participants with total-ALP normalizationdate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Time to total ALP progressiondate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Changes in prostate specific antigen (PSA) in serumdate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Time to PSA progressiondate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Time to first skeletal related event (SRE)date_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- SRE free survivaldate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Time to occurrence of first use of radio-isotopes to relieve skeletal symptomsdate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Time to occurrence of first start of any other anti-cancer treatmentdate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Time to occurrence of first deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)date_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Quality of life (QoL)QoL is assessed by the scores got from the Functional Assessment of Cancer Therapy in subjects with prostate cancer (FACT-P) questionnaire, EuroQoL (EQ-5D) questionnaire, and the BPI-SF questionnaire.date_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
- Time to pain progressiondate_rangeTime Frame:Up to 36 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1