Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2007-07-31
2008-12-31
Brief Summary
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Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Radium-223 chloride
IV administrations of 100 kBq/kg b.w (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization). Two administrations took place with an interval of 6 weeks
Radium-223 chloride (Xofigo®, BAY88-8223) injection
Sterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration
Interventions
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Radium-223 chloride (Xofigo®, BAY88-8223) injection
Sterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration
Eligibility Criteria
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Inclusion Criteria
* Hormone refractory with evidence of rising prostate-specific antigen (PSA): Subject must be maintained on androgen ablation therapy with luteinizing hormone-releasing hormone agonist or have undergone bilateral orchiectomy
* Serum testosterone level required to be ≤50 ng/dL
* Subjects who have received prior antiandrogen drug therapy: Flutamide, nilutamide, or cyproterone acetate must have stopped at least 4 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation; bicalutamide must have stopped at least 6 weeks prior to study drug administration and progression, as defined by rising PSA as defined below, must have been demonstrated since cessation
* PSA progression: Progressive rise in PSA, defined as two consecutive increases in PSA documented over a previous reference value (measure 1). The first increase in PSA (measure 2) should occur at a minimum of 1 week from the reference value (measure 1). This increase in PSA should be confirmed (measure 3) after a minimum of 1 week. If the confirmatory PSA value (measure 3) is less than the previous value, the subject will still be eligible provided the next PSA measure (measure 4) is found to be greater than the second PSA value (measure 2)
* Skeletal metastases confirmed by bone scintigraphy within the last 6 weeks
* Performance status: Eastern Co-operative Oncology Group (ECOG) 0-2
* Life expectancy: ≥6 months
* Laboratory requirements: Neutrophil count ≥1.5 x 109/L, platelet count ≥100 x109/L, haemoglobin ≥95 g/L, total bilirubin level within normal institutional limits, aspartate aminotransferase and alanine aminotransferase ≤2.5 times upper institutional limit of the normal range, S Creatinine ≤1.5 times upper institutional limit of the normal range
Exclusion Criteria
* Has received chemo-, immunotherapy, or external radiotherapy within the last 4 weeks prior to administration of study drug, or has not recovered from adverse events due to agents administered more than 4 weeks earlier
* More than one regimen of previous cytotoxic chemotherapy
* Has received prior hemibody external radiotherapy
* Has a need for immediate external radiotherapy
* Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last year prior to administration of study drug
* Has started treatment with bisphosphonates less than 3 months prior to administration of study drug. Patients are allowed to be on bisphosphonates provided patient is on a stable dose for \>/= 12 weeks before administration of study drug
* Patients who are \</= 4 weeks (6 weeks for bicalutamide) post withdrawal of antiandrogen therapy
* Patients who have started or stopped systemic steroids, within a week prior to study drug administration, or are expected to be subject to changes in the systemic steroid medication
* Other currently active (relapse within the last 3 years) malignancy (except non-melanoma skin cancer) that are not prostate cancer metastases
* Visceral (e.g. liver, lung) metastases from prostate cancer as assessed by abdominal/ pelvic CT or chest radiograph within six weeks before administration of study drug
* Lymph node metastases with short-axis diameter greater than 2 cm
* Bulky loco-regional disease
* Any other serious illness or medical condition, for example: any uncontrolled infection, any patient who has clinical heart failure severe enough to cause marked limitation of activity, and who is only comfortable at rest; or any patient who has heart failure more severe than this (NYHA Heart Failure Class III or IV), Crohns disease or ulcerative colitis
18 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Sutton, Surrey, United Kingdom
Countries
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References
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Cook G Jr, Parker C, Chua S, Johnson B, Aksnes AK, Lewington VJ. 18F-fluoride PET: changes in uptake as a method to assess response in bone metastases from castrate-resistant prostate cancer patients treated with 223Ra-chloride (Alpharadin). EJNMMI Res. 2011 Jun 7;1(1):4. doi: 10.1186/2191-219X-1-4.
Chittenden SJ, Hindorf C, Parker CC, Lewington VJ, Pratt BE, Johnson B, Flux GD. A Phase 1, Open-Label Study of the Biodistribution, Pharmacokinetics, and Dosimetry of 223Ra-Dichloride in Patients with Hormone-Refractory Prostate Cancer and Skeletal Metastases. J Nucl Med. 2015 Sep;56(9):1304-9. doi: 10.2967/jnumed.115.157123. Epub 2015 Jul 16.
Hindorf C, Chittenden S, Aksnes AK, Parker C, Flux GD. Quantitative imaging of 223Ra-chloride (Alpharadin) for targeted alpha-emitting radionuclide therapy of bone metastases. Nucl Med Commun. 2012 Jul;33(7):726-32. doi: 10.1097/MNM.0b013e328353bb6e.
Hobbs RF, Song H, Watchman CJ, Bolch WE, Aksnes AK, Ramdahl T, Flux GD, Sgouros G. A bone marrow toxicity model for (2)(2)(3)Ra alpha-emitter radiopharmaceutical therapy. Phys Med Biol. 2012 May 21;57(10):3207-22. doi: 10.1088/0031-9155/57/10/3207. Epub 2012 May 1.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe.
Other Identifiers
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2006-006101-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BC1-05
Identifier Type: OTHER
Identifier Source: secondary_id
15302
Identifier Type: -
Identifier Source: org_study_id