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A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)
NCT02034552 · View on ClinicalTrials.gov ↗
Study Summary
The primary objective in this study is to evaluate bone scan response at Week 24 based on the quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223 dichloride in combination with abiraterone acetate or enzalutamide will be investigated. The study will evaluate radiological progression free survival, overall survival, and skeletal events. This study will also explore the clinical utility of different imaging modalities (whole body quantified technetium-99 bone scan, DW-MRI \[diffusion-weighted magnetic resonance imaging\] and NaF \[sodium fluoride\] PET-CT \[positron emission tomography-computed tomography\] scan) and will have a separate central radiological review for applicable secondary and exploratory imaging endpoints. All subjects will be randomized as assigned randomly by the IXRS (interactive voice / web response system) system in a 1:1:1 ratio into one of the treatment arms: radium-223 dichloride alone, 50 kBq/kg (55 kBq/kg after implementation of NIST \[National Institute of Standards and Technology\] update) every 4 weeks for up to 6 doses; radium-223 dichloride, 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks up to 6 doses together with abiraterone acetate 1,000 mg daily and prednisone 5 mg bid (twice daily); radium-223 dichloride 50 kBq/kg (55 kBq/kg after implementation of NIST update) every 4 weeks up to 6 doses together with enzalutamide 160 mg daily. The study will consist of screening, treatment and follow-up periods. Study will continue until disease progression as determined by investigator, or when patient meets criteria for withdrawal from study. Subjects in treatment arms with abiraterone/prednisone or enzalutamide will have the option to continue taking oral study therapy until the end of the study (2 years from the last dose of radium-223 dichloride) if the investigator deems the subject may benefit and there is no clinical or radiological progression. Subjects who discontinue all study treat
Conditions Studied
Interventions
- DRUG Prednisone
- DRUG Enzalutamide
- DRUG Abiraterone acetate
- DRUG Radium-223 dichloride (Xofigo, BAY88-8223)
Study Locations (19)
Arizona
- — Scottsdale
- — Tucson
Louisiana
- — New Orleans
- — Shreveport
New York
- — Syracuse
- — The Bronx
California
- — Los Angeles
Connecticut
- — New Haven
Delaware
- — Newark
District of Columbia
- — Washington D.C.
Florida
- — Plantation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 68 participants |
| Start Date | 2014-03-07 |
| Est. Completion | 2018-06-26 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02034552
The ClinicalTrials.gov registry entry for NCT02034552 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 68 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 143 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions — of which Prednisone is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02034552 reports 19 study locations spanning 16 distinct geographic areas — top geographies include Arizona, Louisiana, New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02034552 about?
NCT02034552 is a clinical study titled "A Randomized Phase IIa Efficacy and Safety Study of Radium-223 Dichloride With Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (CRPC)". The primary objective in this study is to evaluate bone scan response at Week 24 based on the quantified technetium-99 bone scan lesion area (BSLA). The safety of radium-223 dichloride in combination with abiraterone acetate or enzalutamide will be investigated. The study will evaluate radiological ...
What is the current status of trial NCT02034552?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 68 participants. The study started on 2014-03-07. Estimated completion is 2018-06-26.
What conditions does trial NCT02034552 study?
This clinical trial studies the following conditions: Prostatic Neoplasms. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02034552?
The interventions under investigation include: Prednisone (DRUG), Enzalutamide (DRUG), Abiraterone acetate (DRUG), Radium-223 dichloride (Xofigo, BAY88-8223) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02034552?
This trial is sponsored by Bayer, which has 143 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02034552 being conducted?
This trial has 19 study locations across Arizona, California, Connecticut, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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