Prostate CancerPhase 2eRADicAteNCT02097303
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
A Phase 2 study testing Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in people with Prostate Cancer, run by Carolina Research Professionals, LLC at 5 sites in United States.
Trial summary
This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 5 sitesUnited States
- Study dates
- Mar 2014to Dec 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible subjects will conform to all of the inclusion criteria listed below:
- Subject must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
- Subject is willing and able to comply with the protocol, including all study visits and procedures.
- Subject is a male, greater than 18 years at time of enrollment.
- Life expectancy of at least 9 months.
- Subject has histologically documented prostate cancer confirmed by a pathology report from a prostate biopsy or radical prostatectomy specimen.
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- Subject must:
- have initiated a stable dose of daily Abiraterone Acetate plus Prednisone within 90 days of enrollment, or
- plans to initiate a stable daily dose of Abiraterone plus Prednisone within 30 days of the first Radium Ra 223 dichloride treatment.
- Subject must plan to receive all 6 Radium Ra 223 dichloride injections and daily oral doses of Abiraterone plus Prednisone during the trial, per protocol.
- Subject has a history of bone metastasis from prostate cancer as evidenced by imaging performed within 90 days of enrollment from one of the following:
- Tc Bone Scan or
- Sodium Fluoride PET/CT Scan
- If a bone scan is used, solitary lesions which could be contributed to causes other than prostate cancer must be confirmed with a second modality (i.e.: plain films, CT Scan or MRI.
- Subject has Castrate Resistant Prostate Cancer, defined as rising PSA with a testosterone level </= 50ng/dl (2.0 nM/L) while receiving androgen deprivation therapy (medical or surgical castration).
- PSA progression will be defined as at least 2 rising PSA levels taken at least 7 days apart with the 2nd PSA being 2.0 ng/dl or greater.
- Subject has the presence of bone pain requiring treatment with:
- 1) EBRT within the previous 12 weeks prior to enrollment, or 2) Analgesic medications (including but not limited to acetaminophen, NSAIDS, Cox-2 inhibitors, and narcotic Opioids).
- 11. Subject has an ECOG performance status of 0-2 at screening 12. Acceptable hematology and serum biochemistry screening values:
- White Blood Cell (WBC) >/= 3,000/mm3
- Absolute Neutrophil Count (ANC) >1500/mm3
- Platelet (PLT) count >100,000/mm3
- Hemoglobin (HGB) > 10.0 g/dL (100g/L; 6.2 mmol/L
- Creatinine <1.5 ULN
- Total bilirubin level <1.5 X ULN
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <2.5 X ULN
- albumin >25 g/L
- Baseline electrolytes within normal limits ( Sodium, potassium, chloride, calcium, phosphate, magnesium, LDH, γGT, urea, total protein) 13. Normal Liver Function Tests (LFT) and normal Renal Function Tests (RFT) at screening visit. If the subject has LFT's or RFT's greater than 2.5 times the upper limit of normal (ULN), Medical Monitor review, in conjunction with the subject's PI, will be required.
- 14. Subjects receiving Anti-Resorptive medications (such as Zolendronic Acid or denosumab) must be on a stable dose for at least 90 days prior to enrollment (Cycle 1/Week 1/ Day 1). Anti-resorptive medications may be added to the subject's regimen after the End of Treatment visit has been completed. Anti-resorptive medication withdrawal will be allowed per Investigator discretion due to adverse events attributable to that medication.
- 15. Subjects of childbearing potential must agree to use adequate contraception beginning at the enrollment until at least 30 days after the last dose of the study drugs. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
Who cannot join
- Eligible subjects must not meet any of the exclusion criteria listed below:
- Subject has known malignant pleural effusion, or known lung, liver or brain metastasis (lymph node only metastasis < 6 cm in short-axis diameter is allowed).
- Subject has a history of visceral metastatic disease as assessed by abdominal/pelvic CT or chest x-ray within the previous 8 weeks.
- Subject has received previous treatment with Abiraterone Acetate for longer than 90 days prior to enrollment, or any prior treatment with Radium Ra 223 dichloride.
- Subject has a known medical contraindication to Prednisone, Abiraterone Acetate or Radium Ra 223 dichloride.
- Subject is not willing to initiate a stable dose of daily Abiraterone Acetate plus Prednisone within 90 days of enrollment, or does not plan to initiate a stable daily dose of Abiraterone Acetate plus Prednisone within 30 days of the first Radium Ra 223 dichloride treatment.
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- Subject does not plan to receive all 6 infusions of Radium Ra 223 Dichloride and daily Abiraterone Acetate plus Prednisone during the trial, per protocol.
- Subject has received previous strontium-89, samarium-153, rhenium-186, or rhenium-188 for the treatment of bone metastasis within 24 weeks prior to enrollment.
- Subject has received denosumab or Zolendronic Acid for less than 90 days prior to enrollment, or if the subject plans to discontinue an anti-resorptive medication prior to the EOT visit.
- Subject has received an investigational product or experimental therapy within 4 weeks of enrollment, or if initiation of either is planned prior to the EOT visit.
- Subject has had treatment with cytotoxic chemotherapy within the previous 4 weeks, or planned prior to the End of Treatment visit, or failure to recover from adverse events due to cytotoxic chemotherapy administered more than 4 weeks prior to enrollment (persistent myelosuppression, GI toxicity, or severe fatigue (ongoing neuropathy is not exclusionary).
- Subject has a history of any medical condition that may be compromised by an increase in blood pressure, or severe liver insufficiency (r Child-Pugh class B or C).
- Subject has a history of a myocardial infarction or cardiac arrhythmia within 6 months prior to enrollment.
- Subject has a history of previous radiotherapy >25% of bone marrow, including hemibody radiation.
- Subject has a history of any other malignancy within the previous 5 years. A history of squamous or basal cell carcinoma or low-grade superficial bladder cancer that has been adequately treated at least 12 months prior to enrollment is not exclusionary.
- Subject has undergone major surgery within 4 weeks prior to enrollment.
- Subject has had a blood transfusion or erythropoietin stimulation agents within 4 weeks of enrollment.
- Subject has known imminent or established spinal cord compression.
- Subject has a serious concurrent medical condition or psychiatric illness.
- Subject has a history of other serious illness of medical condition including, but not limited to any uncontrolled infection, congestive heart failure New York Heart Association (NYHA) class III or IV, Crohn's Disease or Ulcerative Colitis, uncontrolled hypertension or Bone Marrow Dysplasia at screening.
- Subject has any condition that, in the opinion of the investigator, would impair the patient's ability to comply with study procedures.
- Subject is not able to swallow the study treatment capsules.
- Subject has unmanageable fecal incontinence.
- Subject has a history of any size pelvic lymphadenopathy if it is thought to be a contributor to current hydronephrosis.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Urology Cancer Center and GU Research Network
Omaha, Nebraska, 68130
Oregon Urology Institute
Springfield, Oregon, 97477
Associated Medical Professionals
Syracuse, New York, 13210
Chesapeake urology Research Associates
Towson, Maryland, 21204
About this study
This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.
Read the detailed description
Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and concurrent Abiraterone Acetate plus Prednisone for a minimum duration of 26 weeks.
Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. All adverse events deemed to be study related will be followed until resolution. Including screening, the total duration of the study is 32 weeks.
- Conditions
- Prostate Cancer
- Being tested
- Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone
- Keywords
- Prostate Cancer, Bone Metastasis, Symptomatic, Androgen Independent, Hormone Refractory, Castrate Resistant, AIPC, pre-chemotherapy, Post-chemotherapy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus PrednisoneDrug
Also called Xofigo, Zytiga
Radium Ra 223 dichloride - A targeted alpha particle-emitting pharmaceutical (a radiopharmaceutical drug) is a ready-to-use solution for intravenous injection containing the drug substance radium dichloride. The active moiety is the alpha particle emitting nuclide Ra-223, present as a divalent cation (223Ra2+) and Abiraterone Acetate - A CYP17 inhibitor, indicated in combination with prednisone for the treatment of subjects with metastatic castration-resistant prostate cancer. Administration of Abiraterone Acetate may result in mineralocorticoid-related adverse events (AEs), due to CYP17 inhibition. Therefore, Abiraterone Acetate is administered in combination with Prednisone to reduce the frequency of these AEs.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | All subjects receive concurrent administration of Radium Ra223 Dichloride and Abiraterone Acetate plus Prednisone Receives: Drug: Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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).
Measured: 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.
Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)
Improvement in Bone Pain was assessed using the Bone Pain Inventory (BPI)
- 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.
- 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.
- 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.
Measured: 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.
Secondary outcomes (3)
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.
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.
Measured: 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.
Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment
[Not specified]
Measured: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment
[Not Specified]
Measured: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carolina Research Professionals, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Neal D Shore, MD, Principal investigator, Carolina Research Professionals, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097303
- Sponsor's protocol ID
- CRP-PCA-01 eRADicAte
- Acronym
- eRADicAte
- Status last verified
- Jan 2018
- First submitted
- 21 Mar 2014
- Last updated
- 1 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02097303
- Acronym / sponsor ID
- eRADicAte / CRP-PCA-01 eRADicAte
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Bone Metastasis, Symptomatic, Androgen Independent, Hormone Refractory, Castrate Resistant, AIPC, pre-chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Carolina Research Professionals, LLCUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- Mar 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Posted 1 Feb 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.
Detailed description
Approximately 40 subjects will be enrolled to obtain 30 evaluable subjects. All subjects will receive Radium Ra 223 dichloride every 4 weeks for a total of 6 doses over 24 weeks and concurrent Abiraterone Acetate plus Prednisone for a minimum duration of 26 weeks.
Subjects will be evaluated 30 days after the last dose of Radium Ra 223 dichloride. All adverse events deemed to be study related will be followed until resolution. Including screening, the total duration of the study is 32 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus PrednisoneAll subjects receive concurrent administration of Radium Ra223 Dichloride and Abiraterone Acetate plus Prednisone |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Subject must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
- Subject is willing and able to comply with the protocol, including all study visits and procedures.
- Subject is a male, greater than 18 years at time of enrollment.
- Life expectancy of at least 9 months.
- Subject has histologically documented prostate cancer confirmed by a pathology report from a prostate biopsy or radical prostatectomy specimen.
Key exclusion criteria (24 listed)
- Subject has known malignant pleural effusion, or known lung, liver or brain metastasis (lymph node only metastasis < 6 cm in short-axis diameter is allowed).
- Subject has a history of visceral metastatic disease as assessed by abdominal/pelvic CT or chest x-ray within the previous 8 weeks.
- Subject has received previous treatment with Abiraterone Acetate for longer than 90 days prior to enrollment, or any prior treatment with Radium Ra 223 dichloride.
- Subject has a known medical contraindication to Prednisone, Abiraterone Acetate or Radium Ra 223 dichloride.
- Subject is not willing to initiate a stable dose of daily Abiraterone Acetate plus Prednisone within 90 days of enrollment, or does not plan to initiate a stable daily dose of Abiraterone Acetate plus Prednisone within 30 days of the first Radium Ra 223 dichloride treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus PrednisoneAlso: Xofigo, ZytigaRadium Ra 223 dichloride - A targeted alpha particle-emitting pharmaceutical (a radiopharmaceutical drug) is a ready-to-use solution for intravenous injection containing the drug substance radium dichloride. The active moiety is the alpha particle emitting nuclide Ra-223, present as a divalent cation (223Ra2+) and Abiraterone Acetate - A CYP17 inhibitor, indicated in combination with prednisone for the treatment of subjects with metastatic castration-resistant prostate cancer. Administration of Abiraterone Acetate may result in mineralocorticoid-related adverse events (AEs), due to CYP17 inhibition. Therefore, Abiraterone Acetate is administered in combination with Prednisone to reduce the frequency of these AEs. | Drug | Single arm |
Primary outcome
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
Time frame: 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).
Number and Percentage of Participants With Clinically Meaningful Improvement (CMI) in Pain (Between Baseline and End of Treatment)
Time frame: 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.
3 secondary outcomes
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.
Time frame: 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.
Alkaline Phosphatase (ALP) and Prostate Specific Antigen (PSA) Levels Before and After Treatment
Time frame: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Radiologic Assessment Mean Number of Bone Lesions Before and After the Treatment
Time frame: Baseline and End of Treatment (EOT), approximately 32 weeks from Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neal D Shore, MD principal investigator
Carolina Research Professionals, LLC
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in people with Prostate Cancer, run by Carolina Research Professionals, LLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2018.