Trial · NCT02097303
Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis
NCT02097303, Phase 2, Completed, Carolina Research Professionals, LLC; results first posted 2018-02-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis. Trials, record NCT02097303. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02097303
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis
- NCT number
- NCT02097303
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 36 participants, actual
- Lead sponsor
- Carolina Research Professionals, LLC
- Conditions
- Prostate Cancer
- Interventions
- Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone
- First posted
- 2014-03-27
- Last updated
- 2018-02-01
- Results first posted
- 2018-02-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects. | Following Quality of Life questionnaires were given at each visit: FACT-P assesses symptoms/problems related to prostate carcinoma and its treatment. It is a combination of the FACT- General + the PCS (Range 1-156, higher scores better). The FACT-General (FACT-G) is a 28 item QOL measure that provides a total score as well as subscale scores: Physical (0-28), Functional (0-28), Social (0-28), Emotional (0-24) Well-being, and Satisfaction with Treatment was not assessed for this study (The total range was between 1-108, higher scores better) FACT-TOI is derived from the sum of the Physical Well-Being, Functional Well-Being, and Prostate Cancer subscale scores; a sensitive measure of patient-reported health (Range 1-104, higher scores better) PCS is a 12-item prostate cancer subscale that asks about symptoms and problems specific to prostate cancer (Range 0-48, higher scores better). |
| Primary | Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment) | Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects. | Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI) 1. Pain Severity: Pain severity is the composite of scores of worst pain, least pain, average pain, and pain now. CMI criteria: Decrease \>30% at two consecutive visits in Pain Severity Score in 24 hours without an increase in analgesic use. 2. Pain interference: Pain interference is the composite scores on general activity, mood, walking ability, normal work, relationships with others, sleep and enjoyment of life. CMI criteria: Decrease by 1.25 points or more compared with baseline at two consecutive visits. 3. Transient Pain Flare: Based on the work of Atkinson et al, a transient pain flare was assessed by pain at its worst in 24 hours. CMI criteria: \> 2 points on the BPI-SF Worst Pain scale and subsequent reduction after initiation of Ra-223 and during the first 3 cycles. |
| Secondary | Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported. | Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects. | All adverse events relevant to advanced mCRPC subjects as well as adverse events of interest for both Abiraterone Acetate plus Prednisone and Radium Ra 223 dichloride will be reported. |
| Secondary | Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | \[Not specified\] |
| Secondary | Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | \[Not Specified\] |
| Other | Bone Imaging Response (Number of Participants With Progression and Stable Disease) | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | Bone imaging response was assessed at baseline and at EOT visit. Progression was defined as two or more additional lesions in comparison to the baseline. |
| Other | Overall Response Rate | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | Determination of measurable disease progression or response was based on modified RECIST criteria. Reported is the number of participants with either a partial or complete response, and who had radiological extraskeletal progression. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects. | Improvement at the EOT visit was defined as increase from baseline of \>= 10 points for FACT-P Total Scale. \>9 points for FACT-G Total and FACT-TOI scales, and \>=3 points for the remaining scales. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported. | Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects. | Adverse Events | NUMBER | |
| SECONDARY | Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | ng/dL | MEAN | |
| SECONDARY | Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | Lesions | MEAN | |
| OTHER_PRE_SPECIFIED | Bone Imaging Response (Number of Participants With Progression and Stable Disease) | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment) | Subjects were evaluated at the screening visit, monthly during the study, and 30 days after the last dose of Radium Ra 223 dichloride, which will be approximately 32 weeks after the screening visit of evaluable subjects. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Overall Response Rate | Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | FACT-P Total Scale | 20 | Participants | |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | FACT-G Total Scale | 18 | Participants | |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Treatment Outcome Index (FACT-TOI) | 18 | Participants | |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Prostate Cancer Subscale (PCS) | 25 | Participants | |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Physical Well-being | 19 | Participants | |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Functional Well-being | 17 | Participants | |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Emotional Well-being | 18 | Participants | |
Number and Percentage of Participants With Clinically Meaningful Improvement (Between Baseline and End of Treatment) in Quality-of-Life Determined by the Minimum Increase From Baseline in Scores as Per the QOL CMI Criteria | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Social Well-being | 15 | Participants | |
| Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported. | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Overall Adverse Events | 186 | Adverse Events | |
| Safety Data Was Analyzed and Summarized in Subjects Who Receive at Least One Infusion of Radium Ra 223 Dichloride. Number of Adverse Events Are Being Reported. | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | Grade I or II Adverse Events | 179 | Adverse Events |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 36 | |
| Overall Study | COMPLETED | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 31 | |
| Overall Study | NOT COMPLETED | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 5 |
Source ClinicalTrials.gov
Adverse events35
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 5 | 36 | 9 |
| other | Leukopenia | Blood and lymphatic system disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 3 | 36 | 4 |
| other | Neutropenia | Blood and lymphatic system disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 2 | 36 | 4 |
| other | Pancytopenia | Blood and lymphatic system disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 1 | 36 | 2 |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 1 | 36 | 2 |
| other | Diarrhea | Gastrointestinal disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 7 | 36 | 14 |
| other | Nausea | Gastrointestinal disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 7 | 36 | 21 |
| other | Stomach Pain | Gastrointestinal disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 2 | 36 | 4 |
| other | Abdominal Pain | Gastrointestinal disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 1 | 36 | 2 |
| other | Decreased Appetitie | Gastrointestinal disorders | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 1 | 36 | 3 |
1 to 10 of 35Source ClinicalTrials.gov
See all 35 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 1 | 36 |
| Total, other adverse events | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 30 | 36 |
| Total, serious adverse events | Radium 223 With Concomitant Abiraterone Acetate and Prednisone | 5 | 36 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02097303
GET https://conductscience.org/api/trials/v1/NCT02097303/results?page=2