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A Biomarker Study of Standard-of-care Radium-223 Chloride for Metastatic Castration-resistant Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02346526
Recruitment Status : Completed
First Posted : January 27, 2015
Results First Posted : September 29, 2022
Last Update Posted : September 29, 2022
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Philip J. Saylor, MD, Massachusetts General Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Prostate Cancer
Castration-resistant Prostate Cancer
Castration-resistant Prostate Cancer Metastatic to Bone
Interventions Procedure: Blood Tests
Procedure: CT scan
Procedure: FACBC PET/MRI in a subset of participants
Drug: Radium-223 dichloride
Procedure: bone scan
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Radium-223 Dichloride
Hide Arm/Group Description

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title Radium-223 Dichloride
Hide Arm/Group Description

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Median (Full Range)
Unit of measure:  Years
Age Number Analyzed 22 participants
71
(49 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
0
   0.0%
Male
22
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   4.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
18
  81.8%
More than one race
1
   4.5%
Unknown or Not Reported
2
   9.1%
Current Use of Bisphosphonates   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Yes
4
  18.2%
No
18
  81.8%
[1]
Measure Description: Bisphosphonates are a group of drugs that work by slowing bone loss.
Any Prior Use of Docetaxel  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Yes
5
  22.7%
No
17
  77.3%
Eastern Cooperative Oncology Group (ECOG) Performance Status   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Score 0
10
  45.5%
Score 1
12
  54.5%
Score greater than or equal to 2
0
   0.0%
[1]
Measure Description: ECOG performance status scale describes a participant's level of functioning in terms of their ability to care for themselves, daily activity, and physical ability (walking, working, etc.). The ECOG scale ranges from 0 to 5, with lower scores indicating higher levels of functioning.
Extent of disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Less than 6 metastases
8
  36.4%
6 to 20 metastases
7
  31.8%
Greater than 20 metastases
7
  31.8%
1.Primary Outcome
Title Bone Scan Index
Hide Description Automated bone scan index (aBSI) is an imaging prognostic biomarker used to quantitatively assess effect of therapy. aBSI expresses the tumor burden in bone as a percent of the total skeletal mass. An aBSI value of 1.0 indicates the tumor(s) to be present in 1% of the entire skeleton (arms and legs included).
Time Frame Baseline to 2 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radium-223 Dichloride
Hide Arm/Group Description:

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: percentage of skeletal mass
aBSI at Baseline 2.90  (3.44)
aBSI at 2 months 3.79  (4.28)
2.Secondary Outcome
Title Percentage of Skeletal Mass Occupied by a Lesion, Stratified by 18 Month Survival Status
Hide Description Mean change in automated bone scan index (aBSI) at 2 months (i.e. approximately week 9) as assessed by aBSI will be described by 18 month survival status. In other words, decline in aBSI at 2 months on therapy will be evaluated as a predictive biomarker of survival at 18 months.
Time Frame Baseline and 2 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radium-223 Dichloride / Alive at 18 Months Radium-223 Dichloride / Deceased at 18 Months
Hide Arm/Group Description:

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: percentage of skeletal mass
aBSI at Baseline 1.55  (1.86) 4.38  (4.25)
aBSI at 2 months 2.24  (2.59) 6.44  (5.60)
3.Secondary Outcome
Title Circulating Tumor Cell (CTC) Number
Hide Description The presence of circulating tumor cells (CTCs) in the peripheral blood, will be assessed by by the FDA-approved assay CELLSEARCH® CTC Test, is associated with decreased progression-free survival and decreased overall survival in patients treated for metastatic prostate cancer.
Time Frame Baseline/Day 1, Day 30, Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radium-223 Dichloride / Alive at 18 Months Radium-223 Dichloride / Deceased at 18 Months
Hide Arm/Group Description:

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: circulating tumor cells
Baseline/Day 1 14.70  (29.64) 18.44  (25.36)
Day 30 24.71  (61.00) 15.57  (12.37)
Day 60 11.71  (21.51) 26.86  (28.05)
4.Secondary Outcome
Title Circulating Biomarkers of the Tumor Microenvironment
Hide Description

Bone turnover markers (i.e., serum bone specific alkaline phosphatase and N-telopeptide) and plasma biomarkers of inflammation and angiogenesis will be assessed serially. Our analyses of circulating biomarkers of the tumor microenvironment were more limited than originally planned due to a freezer malfunction that compromised our frozen samples that had been saved for later batched analyses. The reported values within the table below reflect CTCm score which is a previously described analysis that uses droplet digital PCR to assess gene expression from circulating tumor cells (CTCs) isolated using the microfluidic CTC-iChip. CTCm score, by published convention, does not have units and does not have a normal range.

In the present study, the normalized CTCm score was calculated as described previously using weighting coefficients. It is considered better to have a lower CTCm score. The table contains [mean (standard deviation)] of CTCm score for each group at the specified timepo

Time Frame Baseline/Day 1, Day 30, Day 60
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Radium-223 Dichloride / Alive at 18 Months Radium-223 Dichloride / Deceased at 18 Months
Hide Arm/Group Description:

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Overall Number of Participants Analyzed 12 10
Mean (Standard Deviation)
Unit of Measure: gene expression score per 7.5mL blood
Baseline/Day 1 91.11  (201.94) 302.40  (762.97)
Day 30 102.25  (248.64) 42.21  (57.95)
Day 60 294.52  (493.61) 138.29  (138.02)
5.Secondary Outcome
Title Baseline Pain Score Evaluation as a Predictor of Survival
Hide Description

Pain and narcotic analgesic use was assessed by the 4-item Brief Pain Inventory (BPI). This instrument contains 4 items, with each item reported on a scale of 0-10, meaning that total possible range is 0-40. For each question's 0-10 response scale, 0 meant no pain/interference and 10 meant worst pain imaginable/complete interference.

Overall survival (OS) was defined as the interval between the start of therapy and the date of death or censor. For the analysis presented in the table, the algorithm of Contal-O'Quigley was applied to the data using leave-one-out jack-knife resampling to determine the optimal division points according to pain score on 4-item BPI at baseline. Each iteration of the algorithm produced an estimate of the "best" division point based on the data. With this method, optimal cut-point for this cohort was baseline total BPI score < 8 vs ≥8. Median survival for each sub-group is reported as months (with range in parentheses).

Time Frame Baseline through study completion, up to approximately 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
Only 20 out of 22 participants were analyzed due to participant non-compliance.
Arm/Group Title Radium-223 Dichloride / Pain Score Greater Than or Equal to 8 Radium-223 Dichloride / Pain Score Less Than 8
Hide Arm/Group Description:

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Overall Number of Participants Analyzed 6 14
Median (Full Range)
Unit of Measure: months
9.35
(4.10 to 17.50)
33.85
(2.10 to 49.60)
6.Secondary Outcome
Title Baseline Global Health Score Evaluation as a Predictor of Survival
Hide Description

Baseline Global Health Score was reported by participants on a scale of 0 ("The worst health you can imagine") to 100 ("The best health you can imagine"). Overall survival (OS) was defined as the interval between the start of therapy and the date of death or censor, expressed here in months.

For the analysis presented in the table, the algorithm of Contal-O'Quigley was applied to the data using leave-one-out jack- knife resampling to determine the optimal division points according to Global Health Score at baseline. Each iteration of the algorithm produced an estimate of the "best" division point based on the data. With this method, optimal cut-point for this cohort was baseline Global Health Score ≥95 or <95. Median survival for each sub-group is reported as months (with range in parentheses).

Time Frame Baseline through study completion, up to approximately 5 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Only 21 out of 22 participants were analyzed due to participant non-compliance.
Arm/Group Title Radium-223 Dichloride / Global Health Score Greater Than or Equal to 95 Radium-223 Dichloride / Global Health Score Less Than 95
Hide Arm/Group Description:

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

After the screening procedures confirm that a patient is eligible to participate in the research study.

Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments. These treatments are designed to be entirely standard. Extra testing during and after that six month period will be added to standard testing and monitoring.

  • Blood Tests
  • CT scan
  • Bone scan
  • FACBC PET/MRI in a subset of participants

Blood Tests: Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC PET/MRI in a subset of participants: Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.

Radium-223 dichloride: Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.

bone scan: Standard bone scans will be carried out prior to treatment, week 9, and week 25.

Overall Number of Participants Analyzed 7 14
Median (Full Range)
Unit of Measure: months
39.90
(19.30 to 49.60)
12.85
(2.10 to 33.20)
Time Frame through study completion, up to approximately 5 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Radium-223 Dichloride
Hide Arm/Group Description

Ra-223: Each treatment cycle lasted 4 weeks during which the patient received Ra-223 by intravenous infusion on day 1 only. Treatments were given every 4 weeks for a total of 6 treatments. These treatments were designed to be entirely standard. Extra testing during and after that six month period was added to standard testing and monitoring (blood tests, CT, bone scan, and FACBC (fluciclovine) PET/MRI in a subset of participants).

Blood Tests: Blood was drawn for standard and nonstandard testing on day 1, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.

CT scan: Standard CT scans will be carried out prior to treatment, week 9, and week 25.

FACBC (fluciclovine) PET/MRI in a subset of participants: Approximately half of the study patients (n=10) underwent experimental FACBC (fluciclovine) PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9. We did not separate the PET/MRI and non-PET/MRI groups within this adverse event reporting because therapy was identical regardless of whether that imaging was done. The PET and MRI used per this protocol were both clinically available tests (i.e., not experimental).

Radium-223 dichloride: Each treatment cycle lasted 4 weeks during which the patient received Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments were given every 4 weeks for a total of 6 treatments.

Bone scan: Standard bone scans were carried out prior to treatment, week 9, and week 25.

All-Cause Mortality
Radium-223 Dichloride
Affected / at Risk (%)
Total   18/22 (81.82%)    
Hide Serious Adverse Events
Radium-223 Dichloride
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Radium-223 Dichloride
Affected / at Risk (%) # Events
Total   8/22 (36.36%)    
Blood and lymphatic system disorders   
Anemia  1  1/22 (4.55%)  1
General disorders   
General disorders and administration site conditions - Other, specify  1 [1]  1/22 (4.55%)  1
Pain  1  1/22 (4.55%)  1
Edema limbs  1  1/22 (4.55%)  1
Injury, poisoning and procedural complications   
Spinal fracture  1  1/22 (4.55%)  1
Metabolism and nutrition disorders   
Anorexia  1  1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorder - Other, specify  1 [2]  1/22 (4.55%)  1
Back pain  1  1/22 (4.55%)  1
Pain in extremity  1  2/22 (9.09%)  2
Arthritis  1  1/22 (4.55%)  1
Musculoskeletal and connective tissue disorders - other, specify  1 [3]  1/22 (4.55%)  1
Nervous system disorders   
Dizziness  1  1/22 (4.55%)  1
Headache  1  1/22 (4.55%)  1
Paresthesia  1  1/22 (4.55%)  1
Psychiatric disorders   
Depression  1  1/22 (4.55%)  1
Renal and urinary disorders   
Urinary incontinence  1  1/22 (4.55%)  1
Skin and subcutaneous tissue disorders   
Dry skin  1  1/22 (4.55%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
[1]
polydipsia
[2]
hand cramp
[3]
shaking thighs
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Philip Saylor, MD
Organization: Massachusetts General Hospital
Phone: 617-724-5197
EMail: psaylor@mgh.harvard.edu
Layout table for additonal information
Responsible Party: Philip J. Saylor, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02346526    
Other Study ID Numbers: 14-375
ONC-2013-119 ( Other Identifier: Bayer )
First Submitted: January 13, 2015
First Posted: January 27, 2015
Results First Submitted: June 24, 2022
Results First Posted: September 29, 2022
Last Update Posted: September 29, 2022