Trial Outcomes & Findings for Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases (NCT NCT02135484)
NCT ID: NCT02135484
Last Updated: 2022-02-17
Results Overview
Overall survival is measured in months from the time of enrollment until death. Participants who survived longer then the median survival rate of 24.3 months were assigned favorable survival. Participants who survived less than 24.3 months were assigned unfavorable survival.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
3.6 years
Results posted on
2022-02-17
Participant Flow
27 participants consented, 2 participants ineligible (1) withdrawal by subject and (1)screen failure.
Participant milestones
| Measure |
Alpharadin
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Radium 223 in Castrate Resistant Prostate Cancer Bone Metastases
Baseline characteristics by cohort
| Measure |
Alpharadin
n=25 Participants
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
|
|---|---|
|
Age, Continuous
|
66 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
|
Prostate Specific Antigen (PSA) Levels
|
26.9 ng/mL
n=5 Participants
|
|
Total Alkaline Phosphatase Level
|
489 U/L
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
12 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
13 Participants
n=5 Participants
|
|
Gleason Score
Score of 7
|
3 Participants
n=5 Participants
|
|
Gleason Score
Score of 8
|
5 Participants
n=5 Participants
|
|
Gleason Score
Score of 9
|
14 Participants
n=5 Participants
|
|
Gleason Score
Score of 10
|
1 Participants
n=5 Participants
|
|
Gleason Score
Unknown
|
2 Participants
n=5 Participants
|
|
Extent of Bone Metastases
Less than 20
|
8 Participants
n=5 Participants
|
|
Extent of Bone Metastases
More than 20
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3.6 yearsOverall survival is measured in months from the time of enrollment until death. Participants who survived longer then the median survival rate of 24.3 months were assigned favorable survival. Participants who survived less than 24.3 months were assigned unfavorable survival.
Outcome measures
| Measure |
Alpharadin
n=25 Participants
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
|
|---|---|
|
Overall Survival (Favorable and Unfavorable )
Unfavorable Survival
|
13.9 months
Interval 3.3 to 23.1
|
|
Overall Survival (Favorable and Unfavorable )
Favorable Survival
|
36.3 months
Interval 24.3 to 43.1
|
Adverse Events
Alpharadin
Serious events: 0 serious events
Other events: 13 other events
Deaths: 19 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Alpharadin
n=25 participants at risk
Participants treated with standard dosing of Alpharadin 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
Alpharadin: 50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
12.0%
3/25 • Number of events 3 • adverse event data collected up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
3/25 • Number of events 4 • adverse event data collected up to 3 years
|
|
General disorders
Fatigue
|
32.0%
8/25 • Number of events 8 • adverse event data collected up to 3 years
|
|
Investigations
Platelet count decreased
|
12.0%
3/25 • Number of events 3 • adverse event data collected up to 3 years
|
|
Investigations
White blood cell decreased
|
28.0%
7/25 • Number of events 9 • adverse event data collected up to 3 years
|
Additional Information
John C. Araujo, Associate Professor, Genitourinary Medical Oncology
UT MD Anderson Cancer Center
Phone: (713) 792-2830
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place