Trial Outcomes & Findings for Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer (NCT NCT02278055)
NCT ID: NCT02278055
Last Updated: 2023-04-07
Results Overview
Defined as a 30% decline in the Brief Pain Inventory/BPI worse pain item from baseline to week 8, with a confirmed reduction at week 12 without an escalation of the subject's pain regimen from Step 1 to Step 2 or Step 2 to Step 3 of the WHO analgesic ladder.) The baseline BPI worst pain score average will be based on the worst pain scores completed by the participant in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the participant in the 7 day window in order to calculate the average worst pain score. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
COMPLETED
PHASE2
29 participants
8 weeks
2023-04-07
Participant Flow
Participant milestones
| Measure |
Radium-223
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Radium-223
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Progressive Disease
|
4
|
Baseline Characteristics
Non-Randomized Trial Assessing Pain Efficacy With Radium-223 in Symptomatic Metastatic Castration-Resistant Prostate Cancer
Baseline characteristics by cohort
| Measure |
Radium-223
n=29 Participants
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Age, Continuous
|
69 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
29 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 8 weeksDefined as a 30% decline in the Brief Pain Inventory/BPI worse pain item from baseline to week 8, with a confirmed reduction at week 12 without an escalation of the subject's pain regimen from Step 1 to Step 2 or Step 2 to Step 3 of the WHO analgesic ladder.) The baseline BPI worst pain score average will be based on the worst pain scores completed by the participant in the 7 consecutive pretreatment days. A minimum of 4 days of pain scores must be completed by the participant in the 7 day window in order to calculate the average worst pain score. The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
Outcome measures
| Measure |
Radium-223
n=21 Participants
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Percentage of Participants With 30% Decline in the Brief Pain Inventory (BPI) Worst Pain Item From Baseline to Week 8
|
11 Percentage of pts w/pain improvement
|
SECONDARY outcome
Timeframe: 12 weeksNumber of participants with changes from baseline to 12 weeks (or earlier for those who discontinue study therapy). Maximum change (rise or fall) in bone Alkaline phosphatase (ALP) during the treatment period reported.
Outcome measures
| Measure |
Radium-223
n=29 Participants
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)
Count of non pain responders with consecutive decrease in Bone Alkaline Phosphatase
|
18 Participants
|
|
Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)
Count of pain responders with consecutive decrease in Bone Alkaline Phosphatase
|
9 Participants
|
|
Number of Participants With Changes in Bone Alkaline Phosphatase (ALP)
Count of participants with no change
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearSerum C-telopeptide (sCTX-1) N-terminal propeptide of procollagen type 1 (PINP) Changes in total-ALP will be defined as for bone-ALP above
Outcome measures
| Measure |
Radium-223
n=29 Participants
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Number of Participants With Changes in Other Bone Markers:
Count of pain responder participants with consecutive decrease in N-terminal propeptide
|
9 Participants
|
|
Number of Participants With Changes in Other Bone Markers:
Count of participants with no consecutive decrease in N-terminal propeptide
|
20 Participants
|
Adverse Events
Radium-223
Serious adverse events
| Measure |
Radium-223
n=29 participants at risk
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • 1 year
|
|
Gastrointestinal disorders
Esophageal perforation
|
3.4%
1/29 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
6.9%
2/29 • 1 year
|
|
Gastrointestinal disorders
Vomiting
|
3.4%
1/29 • 1 year
|
|
General disorders
Chills
|
3.4%
1/29 • 1 year
|
|
General disorders
Fatigue
|
10.3%
3/29 • 1 year
|
|
General disorders
Fever
|
3.4%
1/29 • 1 year
|
|
General disorders
Malaise
|
6.9%
2/29 • 1 year
|
|
General disorders
Non-cardiac chest pain
|
3.4%
1/29 • 1 year
|
|
General disorders
Pain
|
13.8%
4/29 • 1 year
|
|
Injury, poisoning and procedural complications
Fracture
|
3.4%
1/29 • 1 year
|
|
Investigations
Weight loss
|
3.4%
1/29 • 1 year
|
|
Metabolism and nutrition disorders
Anorexia
|
3.4%
1/29 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
3/29 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
6.9%
2/29 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
3.4%
1/29 • 1 year
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms ben/mal/unk
|
3.4%
1/29 • 1 year
|
|
Nervous system disorders
Radiculitis
|
3.4%
1/29 • 1 year
|
|
Vascular disorders
Hypertension
|
3.4%
1/29 • 1 year
|
|
Vascular disorders
Hypotension
|
3.4%
1/29 • 1 year
|
Other adverse events
| Measure |
Radium-223
n=29 participants at risk
Radium Ra 223 dichloride will be administered as a bolus intravenous (IV) injection (up to 1 minute) at intervals of every 4 weeks for up to 6 cycles. The dosage of Radium Ra 223 dichloride after implementation of the new 2015 NIST standard is 55kBq/kg body weight.
Radium-223
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
20.7%
6/29 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
20.7%
6/29 • 1 year
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
17.2%
5/29 • 1 year
|
|
Investigations
Alkaline phosphatase increased
|
10.3%
3/29 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
10.3%
3/29 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.3%
3/29 • 1 year
|
|
Investigations
White blood cell decreased
|
10.3%
3/29 • 1 year
|
|
Investigations
Creatinine increased
|
6.9%
2/29 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
6.9%
2/29 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.9%
2/29 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.9%
2/29 • 1 year
|
|
Investigations
INR increased
|
6.9%
2/29 • 1 year
|
|
Investigations
Platelet count decreased
|
6.9%
2/29 • 1 year
|
Additional Information
Dr. Michael Morris, MD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place