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PK in Pts With HRPC & Skeletal Metastes

This study has been completed.
Information provided by (Responsible Party):
Bayer Identifier:
First received: April 24, 2008
Last updated: December 11, 2015
Last verified: December 2015

Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart).

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

Condition Intervention Phase
Prostatic Neoplasms
Drug: Radium-223 chloride (Xofigo®, BAY88-8223) injection
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase I, Open-label, Dosimetry, Biodistribution and Pharmacokinetic Study of Alpharadin™ in Patients With Hormone Refractory Prostate Cancer and Skeletal Metastases

Resource links provided by NLM:

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Estimation of whole-body retention of radioactivity at each imaging time post-injection [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Estimation of the individual organ uptake/retention of radioactivity at each time-point post injection [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Estimate retention of administered radioactivity in blood [ Time Frame: Up to 1 week ] [ Designated as safety issue: No ]
  • Estimation of elimination of radioactivity in urine and faeces [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Calculation of estimated absorbed radiation dose to target organs [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 1 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of the biodistribution and dosimetry after the first and second injection [ Time Frame: 7 weeks ] [ Designated as safety issue: No ]
  • Prostate specific antigen (PSA) response [ Time Frame: At baseline, before injections, and at 2 month intervals during the 12 month follow up period ] [ Designated as safety issue: No ]
    PSA decline, defined as the number of patients with a confirmed ≥50% reduction in PSA level after treatment with respect to the pre-injection PSA level and the time to PSA progression after PSA response

  • Survival [ Time Frame: 6 and 12 months after the first injection ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Laboratory variables; serum biochemistry and haematology [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Systolic/diastolic blood pressure, respiratory rate, heart rate and body temperature

  • ECG (12 leads) [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    Electrocardiogram (12 leads)

  • Physical examination [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
Drug: Radium-223 chloride (Xofigo®, BAY88-8223) injection
Sterile, clear and colourless aqueous solution of radium-223 chloride free of endotoxins, for intravenous administration


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the prostate
  • 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 an investigational drug within 4 weeks prior to the administration of radium-223, or is scheduled to receive one during the treatment and post-treatment period
  • 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
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Please refer to this study by its identifier: NCT00667537

United Kingdom
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Bayer Identifier: NCT00667537     History of Changes
Other Study ID Numbers: 15302  2006-006101-88  BC1-05 
Study First Received: April 24, 2008
Last Updated: December 11, 2015
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases processed this record on October 21, 2016